U.S. GOVERNMENT PUBLISHING OFFICE

25–747 PDF WASHINGTON : 2018

EXAMINING FDA’S MEDICAL DEVICE USER FEE 

PROGRAM 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED FIFTEENTH CONGRESS 

FIRST SESSION 

MARCH 28, 2017 

Serial No. 115–20 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

GREG WALDEN, Oregon 

Chairman 

JOE BARTON, Texas 

Vice Chairman 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

BILL FLORES, Texas 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

KEVIN CRAMER, North Dakota 

TIM WALBERG, Michigan 

MIMI WALTERS, California 

RYAN A. COSTELLO, Pennsylvania 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

PETER WELCH, Vermont 

BEN RAY LUJA ́ N, New Mexico 

PAUL TONKO, New York 

YVETTE D. CLARKE, New York 

DAVID LOEBSACK, Iowa 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

RAUL RUIZ, California 

SCOTT H. PETERS, California 

DEBBIE DINGELL, Michigan 

SUBCOMMITTEE ON HEALTH

MICHAEL C. BURGESS, Texas 

Chairman 

BRETT GUTHRIE, Kentucky 

Vice Chairman 

JOE BARTON, Texas 

FRED UPTON, Michigan 

JOHN SHIMKUS, Illinois 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILLY LONG, Missouri 

LARRY BUCSHON, Indiana 

SUSAN W. BROOKS, Indiana 

MARKWAYNE MULLIN, Oklahoma 

RICHARD HUDSON, North Carolina 

CHRIS COLLINS, New York 

EARL L. ‘‘BUDDY’’ CARTER, Georgia 

GREG WALDEN, Oregon (ex officio) 

GENE GREEN, Texas 

Ranking Member 

ELIOT L. ENGEL, New York 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

DORIS O. MATSUI, California 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

BEN RAY LUJA ́ N, New Mexico 

KURT SCHRADER, Oregon 

JOSEPH P. KENNEDY, III, Massachusetts 

TONY CA ́ RDENAS, California 

ANNA G. ESHOO, California 

DIANA DEGETTE, Colorado 

FRANK PALLONE, JR., New Jersey (ex 

officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 4 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement ................................................................................................ 5 

Prepared statement .......................................................................................... 6 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 7 

Prepared statement .......................................................................................... 8 

WITNESSES

Jeffrey Shuren, M.D., Director, Center for Devices and Radiological Health, 

Food and Drug Administration, Department of Health and Human Services ......................................................................................................................... 9

Prepared statement .......................................................................................... 11 

Answers to submitted questions 1 ................................................................... 97 

Cynthia A. Bens, Vice President of Public Policy, Alliance for Aging Research 55 

Prepared statement .......................................................................................... 58 

Answers to submitted questions 1 ................................................................... 102 

Robert Kieval, Founder and Chief Executive Officer, CVRx ................................ 66 

Prepared statement .......................................................................................... 68 

Patrick Daly, President and Chief Executive Officer, Cohera Medical ............... 74 

Prepared statement .......................................................................................... 76 

Answers to submitted questions 1 ................................................................... 105 

Diane Wurzburger, Executive of Regulatory Affairs, GE Healthcare, on Behalf 

of the Medical Imaging & Technology Alliance ................................................. 81 

Prepared statement .......................................................................................... 83 

1Dr. Shuren, Ms. Bens, and Mr. Daly did not answer submitted questions 

for the record by the time of printing. 

(1) 

EXAMINING FDA’S MEDICAL DEVICE USER 

FEE PROGRAM 

TUESDAY, MARCH 28, 2017 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:15 a.m., in Room 

2123 Rayburn House Office Building, Hon. Michael Burgess (chairman of the subcommittee) presiding. 

Members present: Representatives Burgess, Guthrie, Upton, 

Shimkus, Murphy, Blackburn, Lance, Griffith, Bilirakis, Long, 

Bucshon, Brooks, Mullin, Hudson, Collins, Carter, Walden (ex officio), Green, Schakowsky, Butterfield, Matsui, Castor, Schrader, 

Kennedy, Eshoo, DeGette, and Pallone (ex officio). 

Staff present: Zachary Dareshori, Staff Assistant; Jordan Davis, 

Director of Policy and External Affairs; Paul Edattel, Chief Counsel, Health; Adam Fromm, Director of Outreach and Coalitions; Jay 

Gulshen, Legislative Clerk, Health; Katie McKeough, Press Assistant; Carly McWilliams, Professional Staff Member, Health; Jennifer Sherman, Press Secretary; John Stone, Senior Counsel, 

Health; Hamlin Wade, Special Advisor for External Affairs; Jeff 

Carroll, Minority Staff Director; Tiffany Guarascio, Minority Deputy Staff Director and Chief Health Advisor; Dan Miller, Minority 

Staff Assistant; Olivia Pham, Minority Health Fellow; Samantha 

Satchell, Minority Policy Analyst; Kimberlee Trzeciak, Minority 

Health Policy Advisor; and C.J. Young, Minority Press Secretary. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. The Subcommittee on Health will now come to 

order. 

The Chair starts by recognizing himself for 5 minutes for the 

purpose of an opening statement. 

Dr. Shuren, welcome back to our subcommittee. I am glad to say 

that your center at the Food and Drug Administration certainly, 

since 2012, I just have to acknowledge that there has been a—you 

have come a long way since the User Fee Agreement authorization 

from 2012. 

Today is this subcommittee’s third hearing to consider the reauthorization of the Food and Drug Administration User Fee Programs that are set to expire in September. The Medical Device 

User Fee Agreement gives the Food and Drug Administration the 

authority to collect fees from the medical device industry and to 

2 

support product review activities. This must be renewed every 5 

years. The Energy and Commerce Committee has taken the necessary actions to renew this authority three times before, and this 

committee remains dedicated to completing this fourth authorization in a timely manner. 

While there can always be room for improvement, the Medical 

Device User Fee Agreements Program has significantly enhanced 

the efficiency, the transparency, and the uniformity of the product 

review process at the Food and Drug Administration. Leading up 

to the 2012 reauthorization of the Medical Device Agreements, this 

subcommittee heard repeatedly about the sometimes slow, sometimes onerous, sometimes arbitrary process by which devices were 

reviewed at the Center for Devices and Radiological Health. The 

state of affairs at the Center for Devices was driving away investment in research and development and significantly hindering the 

pace at which American patients had access to new medical technologies. Through the Food and Drug Administration Safety and 

Innovation Act, Congress reauthorized the Medical Device User Fee 

Agreements, and the paradigm started to shift in what I consider 

to be the right direction. 

The Food and Drug Administration Safety and Innovation Act included meaningful regulatory reforms, improved communication between the industry and the Food and Drug Administration, and increased accountability at the Centers for Devices and Radiological 

Health. It is important that the next Medical Device User Fee 

Agreement continue to build upon the progress that was made in 

the last FDA reauthorization bill as well as the good policies that 

members of this subcommittee championed during the discussions 

on the 21st Century Cures Act. 

I am encouraged that the proposed agreement transmitted to 

Congress in January contains many promising elements that will 

be good for the Food and Drug Administration, good for the industry, but, most importantly, good for our patients. In the proposed 

agreement, the Food and Drug Administration has agreed to further decrease the total time it takes from submission of an application to a final decision on approval. This is a good thing because 

it will get safe and effective products to doctors and to patients 

faster. 

Further, the Food and Drug Administration would enhance patient engagement by more formally involving patient preference 

and patient-reported outcomes in the review process. It is vital that 

the Food and Drug Administration routinely incorporate the patient perspective in its decisionmaking process. 

The proposed agreement would also establish process improvements and goals that ought to foster a more timely and efficient 

approval process if implemented. For instance, the process for presubmission and interactions between the Food and Drug Administration and the industry would be updated and improved upon. In 

addition, the proposed agreement would establish a pilot program 

to examine the use of real-world evidence for pre-market activities. 

Furthermore, the proposed agreement provides for improved 

transparency and for greater responsibility. A wide array of new 

measures, new tools, and reports will provide data that is necessary to ensure that the Food and Drug Administration is meeting 

3 

the goals of the agreement. Reauthorizing the Medical Device User 

Fee Agreements and the user fee programs we have previously discussed would increase efficiency at FDA and ensure that American 

patients benefit from advances in biomedical technology, that 

American patients benefit from advances and innovations as soon 

as safely possible. 

I want to thank all of our witnesses for being here today on both 

panels. I look forward to hearing from each of you about how the 

substance of the proposed User Fee Agreement will accomplish its 

stated goal. 

[The prepared statement of Mr. Burgess follows:] 

PREPARED STATEMENT OF HON. MICHAEL C. BURGESS

The subcommittee will come to order. 

The Chair will recognize himself for an opening statement. 

Dr. Shuren, welcome back to our subcommittee. I am glad to say that your Center 

at FDA has come a long way since the 2012 reauthorization of the Medical Device 

User Fee Amendments (MDUFA). 

Today is this subcommittee’s third hearing to consider the reauthorization of FDA 

user fee programs set to expire in September. MDUFA gives FDA authority to collect fees from the medical device industry to support product review activities, and 

must be renewed every 5 years. The Energy and Commerce Committee has taken 

the necessary actions to renew this authority three times before, and this committee 

remains dedicated to completing this fourth authorization in a timely manner. 

While there will always be room for improvement, the MDUFA program has significantly enhanced the efficiency, transparency, and uniformity of the product review process at FDA. Leading up to the 2012 reauthorization of MDUFA, this subcommittee heard repeatedly about the slow, onerous, and arbitrary process by which 

devices were reviewed at the Center for Devices and Radiological Health (CDRH). 

The state of affairs at CDRH was driving away investment in research and development, and significantly hindering the pace at which American patients had access 

to new medical technologies. Through the Food and Drug Administration Safety and 

Innovation Act (FDASIA) Congress reauthorized MDUFA and the paradigm started 

to shift in the right direction. 

FDASIA included meaningful regulatory reforms, improved communication between industry and FDA, and increased accountability at CDRH. It is important 

that the next medical device user fee agreement continue to build upon the progress 

made in FDASIA, as well as the good policies members of this subcommittee championed in the 21st Century Cures Act. I am encouraged that the proposed agreement transmitted to Congress in January contains many promising elements that 

will be good for FDA, industry, and most importantly, patients. 

In the proposed agreement, FDA has agreed to further decrease the total amount 

of time it takes from submission of an application to a final decision on approval. 

This is a good thing because it will get safe and effective products to doctors and 

patients faster. 

Further, FDA would enhance patient engagement by more formally involving patient preference and patient reported outcomes in the review process. It is vital that 

FDA routinely incorporate the patient perspective in its decision-making process. 

The proposed agreement would also establish process improvements and goals 

that ought to foster a more timely and efficient approval process if implemented. 

For instance, the process for pre-submission interactions between FDA and industry 

would be updated and improved upon. In addition, the proposed agreement would 

establish a pilot program to examine the use of real-world evidence for premarket 

activities. 

Furthermore, the proposed agreement provides for improved transparency and 

greater responsibility. A wide array of new measures, tools, and reports will provide 

data that is necessary to ensure FDA is meeting the goals of the agreement. 

Reauthorizing MDUFA and the user fee programs we have previously discussed 

would increase efficiency at FDA and ensure that American patients benefit from 

advances in biomedical technology and innovation as soon as safely possible. 

I thank all of our witnesses for being here, and I look forward to hearing from 

each of you about how the substance of the proposed agreement will accomplish this 

goal. 

4 

Mr. BURGESS. It is now my pleasure to recognize the ranking 

member of the subcommittee, Mr. Gene Green of Texas, for 5 minutes for the purpose of an opening statement. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Thank you, Mr. Chairman, and thank Dr. Shuren 

and our other witnesses for being here this morning. 

Modeled after the successful Prescription Drug User Fee Agreement, the Medical Device User Fee Agreement was first established in 2002. It authorizes the FDA to collect fees from medical 

device manufacturers to support the work of reviewing device applications and other components of medical device oversight. 

We are here today to learn about the fourth iteration of the Medical Device User Fee Agreement, or as we call it, PDUFA. This, 

similar to other user fee agreements, is an important tool to help 

ensure that the FDA can evaluate devices efficiently while upholding its gold standard of approval. 

Today is markedly different from where we were 5 years ago. 

There was widespread frustration with the program and the challenges facing the FDA. Medical device companies, and patients 

were in need. Thanks to investments provided by the industry, congressional leadership, and a commitment from the agency to double-down and address inadequacies head-on, substantial progress 

has been made. 

From 2009 to 2015, the time it takes for the FDA to issue a decision on PMA is down by 35 percent and down by 11 percent for 

510(k) submissions. Critically, this has happened without any sacrifice in the FDA’s gold standard for safety and effectiveness. 

And I want to thank Dr. Shuren for his leadership in changing 

the culture and policies and the processes of the Center for Devices 

and Radiological Health. This along with user fee funds and reforms instituted by Congress have resulted in an improved medical 

device pipeline, most importantly, innovative device technologies 

reaching patients in the United States earlier than in the past. 

Progress made since MDUFA III demonstrates the importance of 

user free programs and underscores how critical it is that Congress 

reauthorize the program without delay. We also recognize that 

more work remains to improve the innovation and ecosystem and 

realize the full potential of scientific breakthroughs, so patients can 

access new cures and treatments. Past efforts, combined with the 

provisions of this new User Fee Agreement, will keep things headed in the right direction. 

Measuring the total time for submission to an FDA decision on 

an application is a central measure of the user fee process. The 

MDUFA IV agreement would continue to drive towards reducing 

the total time that is spent reviewing submissions which brings innovator companies additional certainty and ensures breakthroughs 

get from the lab table to the bedside in a timely manner. 

The agreement also includes provisions to further enhance the 

predictability and efficiency of the review process. These provisions 

lay the groundwork for further performance improvements and advances in patient safety. 

5 

MDUFA IV includes a new Quality Management Program to improve consistency and predictability in the review process. It will 

allow the FDA to strengthen partnership with patients to make 

sure that the patient remains at the center of the develop and review consideration. 

MDUFA IV will help get the National Evaluation System for 

Health Technology, or NEST, off the ground. Harnessing real-world 

data collected during the routine care, NEST has the potential to 

shorten the time and lower the cost it takes to bring a new device 

to market, expand approved uses for products already in the market, and meet post-market reporting requirements. Critically, 

NEST will enable faster identification of safety issues. This will 

allow the FDA to be more proactive in addressing safety concerns, 

which will reduce harm to patients and liability for companies. 

21st Century Cures included a number of improvements to the 

medical device pre- and post-market review processes. I am 

pleased, as agreement builds on past User Fee Agreements and reforms included in Cures, it maintains our shared commitment to 

ensuring patients benefit from innovative, safe devices necessary 

for public health and fostering a robust pipeline of new treatments 

and cures. 

The MDUFA IV agreement is supported by a broad range of 

stakeholders and is a result of extensive public input and review 

during the drafting process. It will expedite the availability of innovative products and continue to increase the efficiency of FDA. In 

short, this agreement is good for the medical device industry, 

healthcare providers, the FDA, and, most importantly, good for patients. 

I want to thank the FDA and the industry and patient advocates 

and providers and other stakeholders for their work on this agreement. 

And I want to thank again our witnesses for being here today. 

I look forward to your testimony and response to our committee’s 

question. 

I yield back my time. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. 

The Chair now is pleased to recognize the chairman of the full 

committee, Mr. Greg Walden from Oregon, 5 minutes for your 

opening statement, please. 

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

Mr. WALDEN. Thank you, Chairman Burgess, for your work on 

this and many other issues. 

I want to welcome all of our witnesses. I have read through your 

testimony. It is most helpful as we work on this matter. 

The last time Congress reauthorized Medical Device User Fee 

Amendments, MDUFA, in 2012, we heard story after story about 

venture capital drying up, innovation, medical technology companies launching their products overseas. We heard oftentimes years 

before American patients could benefit from them. 

Witnesses from all sides of the political spectrum came before the 

subcommittee. They highlighted the burdensome, inconsistent, and 

6 

opaque nature of the FDA review process as the primary driver for 

these alarming trends. That was 2012. What a difference 5 years 

makes. 

Thanks to Dr. Burgess and others, the Food and Drug Administration Safety and Innovation Act included a number of commonsense regulatory improvements that greatly benefitted patients and 

have spurred innovation. 

I would like to specifically thank Dr. Jeff Shuren who is with us 

today. Thank you for your leadership. You have done great work. 

All the legislation in the world could not change the deeply rooted cultural issues that were plaguing the Device Center at FDA. 

Dr. Shuren, you took constructive feedback to heart. You put these 

new legislative authorities to work and you got results for the 

American people. 

Since 2009, the number of innovative devices approved by the 

FDA has almost quadrupled, resulting in American patients benefitting from safe and effective American technologies sooner. In 

2009, it took an average of 427 days before the FDA even reached 

the decision on a Pre-market Approval Application, a PMA. As of 

2015, the average review time was down to 276 days. That is a 25- 

percent decrease. 

More work lies ahead, but great strides have been made. Building upon the successful implementation of the previous User Free 

Agreement, 21st Century Cures legislation, heralded through this 

process by my friend from Michigan, Mr. Upton, and others, that 

also included a number of additional bipartisan process reforms reauthorizing MDUFA in a timely fashion, which I remain steadfastly committed to doing. It will ensure that we continue to move 

in the right direction. 

Today’s hearing continues these positive efforts. This is a good 

agreement that will build upon some recent successes and 

strengthen the agency, improve the lives of patients, and bolster 

America’s medical technology sector, which has brought hundreds 

of thousands of high-paying jobs to our communities. It is also a 

critical next step after the game-changing 21st Century Cures Act 

became law just a few months ago. So, let’s continue to build upon 

these remarkable and bipartisan advancements that put patients 

first. 

Thank you again for the hard work that has gone into this agreement. We look forward to hearing from all of you and moving 

ahead in this area. 

With that, Mr. Chairman, if there are others seeking time, I 

would be happy to yield the balance. Otherwise, I will yield back 

and we can get on with the hearing. 

[The prepared statement of Mr. Walden follows:] 

PREPARED STATEMENT OF HON. GREG WALDEN

Thank you, Chairman Burgess. 

What a difference 5 years makes. The last time Congress reauthorized the Medical Device User Fee Amendments (MDUFA) in 2012, we heard story after story 

about venture capital drying up and innovative medical technology companies 

launching their products overseas, oftentimes years before American patients could 

benefit from them. Time after time, witnesses from all sides of the political spectrum came before this subcommittee and highlighted the burdensome, inconsistent, 

7 

and opaque nature of the FDA review process as the primary driver of these alarming trends. 

Thanks to Dr. Burgess and others, the Food and Drug Administration Safety and 

Innovation Act (FDASIA) included a number of common-sense regulatory improvements that greatly benefitted patients and spurred innovation. I also want to thank 

Dr. Jeff Shuren for his leadership. All of the legislation in the world could not 

change the deeply rooted cultural issues that were plaguing the device center at 

FDA. He took these criticisms to heart and then put these new legislative authorities to work. 

Since 2009, the number of innovative devices approved by the FDA has almost 

quadrupled and American patients are benefiting from safe and effective American 

technologies sooner. In 2009, it took an average of 427 days before FDA even 

reached a decision on a premarket approval application (PMA). As of 2015, the average review time was down to 276 days—a 35 percent decrease. 

Building upon the successful implementation of the previous user fee agreement, 

21st Century Cures included a number of additional bipartisan process reforms. Reauthorizing MDUFA in a timely fashion-which I remain steadfastly committed to 

doing-will ensure that we continue to move in the right direction. This is a good 

agreement that will further strengthen the agency, improve the lives of patients, 

and bolster America’s medical technology sector which has brought hundreds of 

thousands of high-paying jobs to our communities. 

Mr. WALDEN. With that, Mr. Chairman, if there are others seeking time, I would be happy to yield the balance. Otherwise, I will 

yield back and we can get on with the hearing. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. 

The Chair, then, recognizes the ranking member of the full committee, Mr. Pallone of New Jersey, 5 minutes for your opening 

statement, please. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Mr. Chairman. 

I appreciate the opportunity today to discuss the reauthorization 

of the Medical Device User Fee Amendments. I am pleased to see 

the progress that has been made under MDUFA in reducing review 

times for medical devices as well as ensuring that the Center for 

Devices and Radiological Health is well-resourced and well-staffed. 

I would also be remiss if I didn’t acknowledge the positive response from industry in terms of how MDUFA III is working, a 

dramatic shift from where things stood prior to reauthorization in 

2012. 

A lot has been accomplished in meeting the goal of reduced review times under the MDUFA program. Average total review times 

for 510(k)s are down by 11 percent and average total review times 

for pre-market applications are down by 35 percent, or 150 days. 

Importantly, CDRH also approved the highest number of novel 

devices in the history of the MDUFA program in 2016, approving 

91 new devices. While more work needs to be done, this progress 

has resulted in patient access to safe and effective medical devices 

more quickly, which is a goal I think we all share. 

And MDUFA IV will build on these successes by working to improve the Medical Device User Free Program. It will advance the 

use of the patient perspective and the risk/benefit assessment of 

medical devices. It will also establish a system called the NEST to 

utilize real-world data for pre-market approval of new indications 

8 

and post-market safety monitoring. It tailors the use of the thirdparty review program and improves pre-submission communications with sponsors. All of these actions will help to improve the 

consistency, efficiency, and effectiveness of medical device reviews. 

Just as I have said before on the other User Fee Agreements, the 

agreement before us today is the result of many negotiations with 

industry and stakeholders, consultations with patients and consumers, and solicitation of public input. The resulting recommendations were transmitted to Congress in meeting the January 15th 

statutory deadline. 

Transmitting new recommendations at this point would go 

against this requirement and run the very real risk of MDUFA not 

being reauthorized before the program expires on September 30th. 

Any delays would endanger the review of innovation medical devices and threaten the jobs of thousands of FDA employees. 

So, I intend to continue to work with my colleagues on the committee and across the Capitol as well as industry to ensure that we 

do not let this happen. This is a strong agreement and one that deserves our support, and I look forward to continuing our work on 

all of the User Fee Agreements to ensure that they are signed into 

law as soon as possible. 

[The prepared statement of Mr. Pallone follows:] 

PREPARED STATEMENT OF HON. FRANK PALLONE, JR. 

Thank you, Mr. Chairman. I appreciate the opportunity today to discuss the reauthorization of the Medical Device User Fee Amendments. 

I am pleased to see the progress that has been made under MDUFA in reducing 

review times for medical devices, as well as ensuring that the Center for Devices 

and Radiological Health (CDRH) is well-resourced and well-staffed. I would also be 

remiss if I did not acknowledge the positive response from industry in terms of how 

MDUFA III is working, a dramatic shift from where things stood prior to reauthorization in 2012. 

A lot has been accomplished in meeting the goal of reduced review times under 

the MDUFA program. Average total review times for 510(k)s are down by 11 percent, and average total review times for pre-market applications are down by 35 

percent or 150 days. Importantly, CDRH also approved the highest number of novel 

devices in the history of the MDUFA program in 2016, approving 91 new devices. 

While more work needs to be done, this progress has resulted in patient access to 

safe and effective medical devices more quickly, which is a goal I think we all share. 

MDUFA IV will build on these successes by working to improve the medical device user fee program. It will advance the use of the patient perspective in the riskbenefit assessment of medical devices. It also establishes a system called the NEST 

to utilize real world data for premarket approval of new indications and post-market 

safety monitoring. It tailors the use of the Third Party Review program, and improves pre-submission communication with sponsors. All of these actions will help 

to improve the consistency, efficiency, and effectiveness of medical device reviews. 

Just as I have said before on the other user fee agreements, the agreement before 

us today is the result of many negotiations with industry and stakeholders, consultations with patients and consumers, and solicitation of public input. The resulting recommendations were transmitted to Congress in meeting the January 15, 

2017 statutory deadline. Transmitting new recommendations at this point would go 

against this requirement, and run the very real risk of MDUFA not being reauthorized before the program expires on September 30. Any delays would endanger the 

review of innovative medical devices and threaten the jobs of thousands of FDA employees. 

I intend to continue to work with my colleagues on the committee and across the 

Capitol, as well as industry, to ensure that we do not let this happen. This is a 

strong agreement, and one that deserves our support, and I look forward to continuing our work on all of the user fee agreements to ensure they are signed into 

law as soon as possible. 

Thank you. 

9 

Mr. PALLONE. I have 2 minutes left. I don’t think anybody wants 

the time. But, with that, I will yield back, Mr. Chairman. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. 

And that concludes Member opening statements. The Chair 

would like to remind Members that, pursuant to committee rules, 

all Members’ opening statements will be made part of the record. 

Again, we want to thank our witnesses for being here today, for 

taking time to testify before the subcommittee. Each witness will 

have the opportunity to give an opening statement, followed by 

questions from Members. 

We will have two panels of witnesses today, and we are going to 

begin with Dr. Jeffrey Shuren, the Director for the Center for Devices and Radiological Health at the Food and Drug Administration, no stranger to this subcommittee. 

Welcome back, Dr. Shuren. We look forward to your testimony. 

You are recognized for 5 minutes, please. 

STATEMENT OF JEFFREY SHUREN, M.D., DIRECTOR, CENTER 

FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND 

DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Dr. SHUREN. Chairmen Walden and Burgess, Ranking Members 

Pallone and Green, and members of the subcommittee, thank you 

for the opportunity to discuss the reauthorization of the Medical 

Device User Fee Amendments, or MDUFA, today. 

When I was last here testifying about MDUFA, I am sure many 

of you recall, and have already mentioned, that the program was 

in a much different place. Since then, much has changed for the 

better, but we have more work to do. 

As you have heard, between 2010 and 2016, we reduced the average total time to reach a decision on the 510(k), the submission 

type for lower-risk medical devices, by 11 percent. Between 2009 

and last year, we reduced the average total time to reach a decision 

on a PMA, the submission type for a high-risk device, by 35 percent, reducing by 150 days. 

But we went beyond our MDUFA III commitments. For example, 

we reduced the median time to approve a clinical trial submission 

from 442 days in 2011 to just 30 days in 2015 and 2016, a 93-percent decrease. Changes we have made at the Center for Devices 

and Radiological Health, or CDRH, to our culture, our policies, and 

our processes, the investments provided by industry through user 

fee funding, and the direction provided by Congress through 

changes to Federal law, have resulted in improved medical device 

pipeline and innovative technologies being introduced in the U.S. 

earlier than in the past. In fact, the number of novel devices we 

have approved has almost quadrupled from 24 in 2009, when I first 

came to CDRH, to 91 in 2016, the highest since the start of the 

User Fee Program in 2003. 

Last year we approved the first artificial pancreas, working 

interactively with the device manufacturer from the early stages of 

development. We approved the first device in the world that is intended to automatically monitor glucose levels around the clock 

and automatically provide insulin doses. Overall, working with the 

10 

manufacturer, we helped bring this technology to market 3 years 

earlier than the company originally intended to do. 

MDUFA IV could continue that trajectory for more timely patient 

access to novel technologies, supporting CDRH’s vision that patients in the U.S. have access to high-quality, safe, and effective 

medical devices of public health importance first in the world. 

The MDUFA IV proposal submitted to Congress in January includes programmatic enhancements, such as a new quality management program that will improve consistency, efficiency, predictability, and the application of the least-burdensome approach in 

our pre-market review processes and decisionmaking. The proposal 

would allow FDA to move forward in some critical and strategic 

areas, such as strengthening our partnerships with patients, allowing us to promote more patient-centric clinical trials, advanced benefit/risk assessments that are informed by patient perspectives, and 

foster earlier patient access to new devices. 

Another critical area is the development of the National Evaluation System for health—with a small ‘‘h’’—Technology, or NEST. 

The NEST is a nongovernment system that will be operated by 

stakeholders of the medical device ecosystem, including patients, 

providers, and the device industry, and it would facilitate the use 

of real-world data, collected as a part of routine clinical care, such 

as from electronic health records and registers, consistent with the 

goals of 21st Century Cures. 

A robust NEST will enable manufacturers to harness real-world 

evidence that could enable them to drive down the time and cost 

of bringing new devices to market, expanding the indications to already marketed drugs, meeting post-market reporting requirements, and obtaining payer coverage and reimbursement. The 

NEST will also enable faster identification of safety issues, reducing harm to patients and liability for companies. 

In conclusion, the authorization of the Medical Device User Fee 

Program would expedite the availability of innovative new products, create jobs, protect patients, and provide the enhancements 

that will continue to increase the efficiency of FDA’s programs. Improvements in total time to decision, transparency, consistency, 

predictability, efficiency, and assuring a least-burdensome approach will benefit industry, healthcare providers, and, most importantly, patients. 

Thank you for the opportunity to testify here today. I look forward to answering your questions. 

[The prepared statement of Dr. Shuren follows:] 

11 


25747.001

"Examining FDA's Medical Device User Fee Program" 

Testimony of 

Jeffrey Shuren, M.D., J.D. 

Director, Center for Devices and Radiological Health 

Before the 

United States House of Representatives 

Committee on Energy and Commerce 

Subcommittee on Health 

March 28, 2017 

U.S. Department of Health and Human Services 

U.S. Food and Drug Administration 

www.fda.gov 

(7# 

~ 

m!J U.S. FOOD & DRUG • ADMINISTRATION 

RELEASE ONLY UPON DELIVERY 
12 


25747.002

INTRODUCTION 

Chairman Walden, Ranking Member Pallone, Chairman Burgess, Ranking Member Green, and 

members of the committee: 

Thank you for having me here today. I'm JeffShuren, Director of the Center for Devices and 

Radiological Health (CDRH) at the Food and Drug Administration (FDA). I'm pleased to be 

here today to discuss reauthorization of the Medical Device User Fee Amendments, or MDUFA 

IV. 

The MDUF A reauthorization proposal described below was submitted to Congress in January 

under the previous Administration, and reflects a different approach to the Federal Budget. The 

Blueprint Budget supports many of the goals of the reauthorization proposal but proposes a 

different way of financing these goals. The Administration looks forward to working with 

Congress, with industry input, to develop a reauthorization proposal that speeds the development 

and approval of vital medical devices that are safe and effective. 

MDUFA 

Enacted by Congress in 2002, MDUF A is a user fee program through which medical device 

companies pay fees to FDA when they submit a request for marketing authorization or register 

their establishments with FDA. The program includes commitments between the U.S. medical 

device industry and FDA to improve the predictability, transparency, and consistency of 

regulatory processes, which are intended to reduce the time for FDA to make a decision about 

whether to authorize marketing of a device. 

MDUFA has been reauthorized every five years since Congress created the program. As the 

program has evolved, FDA and industry have successfully negotiated agreements to improve 

patient access to medical devices and streamline regulatory processes. 

During the 2012 MDUFA III testimony, many of you may recall that the program was in a much 

different place 1

: 

1 See Appendix A: "U.S. Food and Drug Administration, Center for Devices and Radiological Health: 

Progress in Achieving Our Vision of Patients First." 
13 


25747.003

• In FY 2009, it took an average of 427 days to reach a decision on a premarket approval 

application (PMA), the submission type required for the highest-risk devices. 

• In FY 20 I 0, it took an average of 150 days to reach a decision on a premarket 

notification submission (also known as a 510(k)), the submission type required for low 

to moderate-risk devices. 

Thanks to the investment provided by industry, and direction provided by Congress, we have 

made substantial progress toward reducing decision times. As of2015: 

• It took an average of just 276 days to reach a decision on a PMA, a 35 percent decrease in 

six years; and 

• It took an average of just 133 days to reach a decision on a 51 O(k), an 11 percent decrease 

in five years. 

Further, we went beyond our MDUFA III commitments to reduce the median time to approve an 

Investigational Device Exemption (IDE) study to just 30 days in FY 2015, down from 442 days 

in FY 20 11-a 93 percent decrease in four years. This improvement has allowed companies to 

begin their clinical trials earlier so they can begin collecting data to support a decision on their 

submission requesting marketing authorization. In addition, we reduced the average time to reach 

a decision on a De Novo classification request, the submission type typically used by novel low 

or moderate-risk devices, to 259 days in FY 2014, down from 770 days in FY 2009-a 66 

percent decrease in five years. 

Changes we have made at CDRH to our culture, policies, and processes-in addition to user fee 

funding and changes to federal law-have resulted in an improved medical device pipeline and 

innovative technologies being introduced in the U.S. earlier than in the past. For example, since 

2009, the number of innovative devices we have approved has almost quadrupled. In 2016, we 

approved 91 innovative devices-the highest of any year since the user fee program began in 

2003. In 2015, we approved the second highest number of innovative devices. 

An example of an innovative technology that FDA approved first in the world is the "artificial 

pancreas," something many members of this Committee supported. Working interactively with 

the device manufacturer from the earliest stages of development to assist in making this 

2 
14 


25747.004

technology available as quickly as possible, FDA approved the first device in the world that is 

intended to automatically monitor glucose levels around the clock and automatically provide 

appropriate insulin doses. 

While we have made progress in many areas, we also recognize that more work remains and 

there are additional opportunities for improvements. We look forward to working with industry 

and Congress to ensure there are sufficient user fees resources as we strive to make these 

improvements. MDUF A IV agreement includes a new quality management program that will 

enhance consistency and predictability in premarket review processes. 

MDUF A IV agreement would also allow FDA to move forward in some critical and strategic 

areas such as strengthening our partnerships with patients2

• Strengthening patient input will 

allow us to promote more patient-centric clinical trials, advance benefit-risk assessments that are 

informed by patient perspectives, and foster earlier access to new devices. 

Another critical area supported by the MDUF A IV agreement is the development of the National 

Evaluation System for health Technology, or NEST3

• The NEST is system owned and operated 

by multiple stakeholders that will use real-world data collected as part of routine clinical care. A 

robust NEST will enable manufacturers to harness real-world evidence that could enable them to 

drive down the time and cost of bringing a new device to market, expand the indications for 

already approved devices, and meet postmarket reporting requirements. The NEST will also 

enable faster identification of safety issues, reducing harm to patients and liability for companies. 

The MDUF A IV agreement, which was supported by a broad array of stakeholders during the 

public review of the draft agreement, will expedite the availability of innovative new products, 

and its enhancements will continue to increase the efficiency of FDA's programs. Improvements 

in total time to decision, transparency, consistency, and predictability will benefit industry, 

healthcare providers, and, most importantly, patients. 

2 See Appendix B: "Center for Devices and Radiological Health (CDRH): 2016-2017 Strategic Priorities- 2016 

Accomplishments." 

3 See Appendix B: "Center for Devices and Radiological Health (CDRH): 20 16·20 17 Strategic Priorities- 2016 

Accomplishments." 

3 
15 


25747.005

CONCLUSION 

The Medical Device User Fee Program has allowed FDA to speed the application review process 

without compromising the Agency's high standards. MDUFA offers a strong example of what 

can be achieved when FDA, industry, and other stakeholders work together towards the same 

goal. The user fees provide a critical way to ensure that FDA has the resources needed to 

conduct reviews in a timely fashion. While we have made demonstrable progress in partnering 

to bring medical devices to market in as timely a manner as possible, we know that more work 

remains to be done to further enhance and optimize our processes. The reauthorization MDUF A 

will allow FDA to build upon the demonstrated success of this program, and in so doing, further 

benefit patients and affirm our nation's standing as a global leader in biomedical innovation. 

4 
16 


25747.006

Appendix A 

Administration 

and 

first 

In the early part of this decade, industry argued that FDA regulation hindered innovation and contributed 

to the growing number of device compan·les seeking marketing authorization for their dev·lces abroad 

before introducing them in the United States, and the increasing gap between when a device is approved 

in another country and when it is approved in the US. This reality, its adverse impact on patients, plus 

CDRH's own awareness of our declining performance over almost a decade, led CDRH to implement new 

programmatic changes. These changes, along with increased user fee funding and changes in Federal law 

have helped us strengthen our performance and better address the rapidly~evolving field of medical 

device innovation. To guide us in our mission to improve the health and quality of life of patients, in 2012 

we adopted a reflect this change in mindset, that: Patients in the US have access to highquality, safe and effective medical devices of public health importance first in the world. 

Since late 2009, CDRH has continuously improved the way we do bus·, ness through a series of culture, 

policy and process changes. This can be seen through our commitment to providing excellent customer 

service, new patient~centered paradigms, and Novel* 

our strong performance across a range of r~~--c~--·--~·-~,~·,_, 

ObJeCtive measures, including the time it takes 

to review several types of medical device 

submissions. These improvements are 

reflected by the nearly four-fold increase in 

the annual number of novel medical device 

approvals. 

fast facts CDRH oversees approximately 175,000 medical devices on the US market, more than 

18,000 medical device manufacturers, and more than 25,000 medical device facilities worldwide. Each year 

we receive some 22,000 premarket submissions (includes supplements and amendments) and more than 

1.4 million reports on medical device adverse events and malfunctions. 

'CDRH Mission, Vision and Shared Values 
17 


25747.007

Time Time, with its cost implications, plays a critical role in an innovator's decision as to whether and 

when to bring a new technology to the US. What good is a new technology if patients do not have timely 

access to ifi How helpful is a new technology that doesn't benefit patients or poses unacceptable risks? 

By reducing the time of every regulatory stage of the total product life cycle, including the review of 

medical device submissions, while still assuring robust but appropriate (least burdensome) evidence 

generation and high-quality decision making, we help patients get access to safe and effective medical 

technologies and foster innovation. After steadily worsening performance from 2002 to 2010 on a variety 

of measures, including pre market review times, CDRH has reduced the decision time on all key premarke· 

submission types. 

While premarket approval applications 

(PMAs) only account for approximately one percent 

of all premarket medical device submissions, they 

represent medical devices with the highest risk to 

patients (Class Ill devices) and, therefore, require 200 

more data and a more rigorous review by CDRH. In 

2009, it took an average of 427 total days to reach a 

decision on a PMA By 2015, we had reduced the 

total decision time by 35 percent, 

Named after its section number in federal 

law, this category represents the bulk of premarket 

submissions for medical devices. Manufacturers 

submit 510(k)s to CDRH for devices with low to 

moderate risk to patients (Class II), and our review 

standard is based on substantial equivalence 

(whether a device is at least as safe and effective as 

a device already on the market). In 2010, it took an 

average of 150 total days to reach a decision on a 

510(k). By 2015, we had reduced the total decision 

time by 11 percent 

De novo classification is a pathway that 

enables manufacturers of certain low to moderate 

risk novel devices for which there are no similar 

marketed devices to come to market, instead of 

having to submit a PM A. In 2009, it took an average 

of 770 total days to reach a de novo decision. By 

2014, we had reduced the total decision time by 66 

percent 

6 

100 

50 

so 

60 

40 

-900 

600 

soo 

400 

300 

100 

100 

PMA Average Total Time to MDUFA Decision 

Comparison at 93% Closed 

2010 

SlO(k) Average Total Time to MDUFA Decision 

Comparison at 98.G% Closed 

2010 2012 2013 

Fiscal Year (Receipt Cohort) 

Average Total Days for De Novo Requests• 

2009 2011 2013 2014 2015 u 

Fiscal Year(ReceiptCohort) 
18 


25747.008

Manufacturers submit Investigational 

Device Exemptions (IDEs) for certain devices they 

want to study via a clinical trial. CDRH reviews an 

IDE submission before a manufacturer ciln begin 

to collect clinical dilta that may be necessary for 

future approval. CDRH slashed median review 

times for IDE full approvals by more than a year 

between 2011 and 2015. 

500 

4SO 

40,0 

3SO 

300 

100 

50 

Median Days to IDE Study Approval 

Fisca!Year 

Since 2009, CDRH has been evaluating all of our programs to address concerns from patients, industry, 

health care providers, our own staff, and other customers about issues including review times, backlogs, 

and our expertise in increasingly complex technology. We have sought to address these concerns by 

changing our culture to put patients first and recognizing that advancing innovation and assuring patient 

safety are not mutually exclusive, revising or eliminating old policies, and developing new policies and 

approaches with an eye on meeting measurable objectives, Increased medical device user fees have 

supported these efforts so that we are better positioned to respond to the needs of patients. 

t~~Ciinical Trials In addition to dramatically improved performance" in reviewing IDEs, CDRH has 

encouraged the use of innovative methodologies and study designs in clinical trials, We recognize that 

manufacturers need CDRH input early and often so that the ultimate device review process moves as 

quickly and smoothly as possible, In 2013, CDRH issued final guidance for manufacturers on early 

feasibility studies to encourage conducting these studies in the US. Innovators tend to market their 

technologies sooner in countries where they elect to conduct their early clinical studies. Since 2013, the 

number of early feasibility studies approved has more than doubled-from 17 in FY 2013 to 40 in FY 2016, 

CDRH encourages the use of innovative clinical trial designs and statistical methods such as adagtive 

and because, where appropriate to use, they can reduce the time and 

cost of a clinical study. In recent years, many devices have come to market based on the results of clinical 

trials using adaptive trial designs. For the period from 2007 to May of 2013, CDRH received 201 

submissions that were adaptive, 

CDRH continues to develop computational models that can, in some instances, supplement or replace 

data from clinical investigations, such as the Virtual Family (VF)§-a set of highly detailed, anatomically 

correct, computational whole-body models, designed to mimic humans of both sexes at various stages of 

growth. Since 2007, more than 160 submissions have included Virtual Family research, 

7 
19 


25747.009

•flexible, Risk-Based Regulatory Approaches CDRH continues to adapt 

our oversight policies to emerging new technologies. In a manner consistent with our statutory mission, 

we now approach a medical technology by first asking whether active CDRH oversight will be valueadded. If not, we take a less active regulatory approach. If it would, we focus on assuring timely patient 

access to technologies that will benefit patients by considering the device's innovation cycles and 

evidence generation needs. 

For example, widespread adoption and use of digital health technologies is creating new and innovative 

ways to improve health and health care delivery. In one of the biggest de-regulatory actions for CDRH in 

decades, to foster greater innovation in the digital health space while promoting public health, we have 

exercised our enforcement discretion to cease subjecting certain tower-risk medical devices (such as apps 

for patient care management and medication reminders) to medical device requirements. 

Additionally, balancing data needs between what's collected before the device comes on the market 

(premarket) and what's collected after it is on the market (postmarket) reflects our approach to best 

assure timely patient access to safe and effective devices. 

In 2015, CDRH completed a @l!:Q2QSS;!J!£~~i:Yi. of the benefit-risk profile of all types of high-risk 

devices to determine if we could reduce premarket data collection requirements for at least some 

devices. As a result, for 30 percent of high-risk medical devices, CDRH determined, based on the current 

body of evidence and experience, we could consider some devices candidates for down-classification, 

eliminate some data requirements or shift some premarket data requirements to the postmarket setting. 

In 2016, CDRH reached out to stakeholders for input on the results of the retrospective reviews, in order 

to determine next steps. 

•Patient-Centered Benefit-Risk For the past 5 years, CDRH has encouraged the use 

of a more flexible, patient-centric, and transparent benefit-risk framework to evaluate medical devices, 

starting with a 2012 guidance on the factors to consider when making benefit-risk determinations in 

support of device premarket approval decisions, which includes patient perspectives on potential benefits 

and risks. We are focusing more on what matters to patients. 

In 2016 and 2017, CDRH expanded this approach by revising the 2012 guidance to include additional 

patient-centric factorsl!l, and issuing two additional benefit-risk guidance documents: one which outlines 

the principal factors CDRH considers when making benefit-risk determinations during the pre market 

rev1ew process and one which outlines factors to consider when determining whether and 

what postmarket actionsll we may take to address a problem, such as a recall, based on the benefits and 

risks of that action to patients. 

Investigational Device Exemptions 12 Guidance Document: Factors to Consider When Making Benefit-Risk Determinations in Medical Device Product 

Availability, Compliance, and Enforcement Decisions 

8 
20 


25747.010

•Patients as Partners CDRH had traditionally determined whether the benefits of a device 

outweighed its risks based on the trade-offs we thought were acceptable. However, patients who live 

with a disease or condition often have their own perspectives on what benefits and risks related to 

medical devices they are willing to accept. CDRH collaborates with patient scientists and other experts 

outside the FDA to help us advance the scientific field of assessing patient preferences and incorporate 

the patient perspective into our benefit-risk assessments and decision-making. 

For example, in 2014, CDRH funded a collaborative study on patient preferences that led to changes in 

our review paradigm for obesity devices, and used the results to inform our decision to approve the first 

medical device for treating obesity since 2007. Better understanding of patient preferences can also help 

rejuvenate development pipelines; since then, CDRH has approved or granted marketing applications for 

five more medical devices that address obesity or weight loss. 

In 2016, CDRH issued a final guidance that outlined patient preference information (PPI)D that CDRH may 

use in decision making. Since then manufacturers have begun to submit-and we have approved-IDEs 

with patient preference studies. 

CDRH's efforts to incorporate the voice of patients in our decision making also are reflected in medical 

device clinical studies, which have been increasingly assessing what matters most to patients. Between 

2009 and 2014, the number of premarket submissions that included clinical studies with patient reported 

outcomes (PROs) increased by more than 500 percent and half of IDE pivotal clinical studies now include 

PROs. 

In 2015, CDRH established the first FDA advisory committee focused on the interests and needs of 

patients, and recruited potential new members in 2016. The Patient Engagement Advisory Committee11 

will hold its first meeting in 2017. 

•National Evaluation System for health Technology (NEST) 

Despite rigorous premarket evaluation, we cannot fully understand how well a medical device works until 

it is used day-to-day by patients, caregivers, and clinicians. Premarket clinical trials provide critically 

important information but we don't understand the long-term benefit-risk profile until it is used in 

routine clinical practice. Currently our nation is limited in its ability to make widespread use of real-world 

evidence (RWE) to best inform all members of the medical device ecosystem. 

CDRH intends for NEST to increase the quality and use of real-world data (RWD) collected as part of 

routine clinical care, which should also help reduce the time and cost of evidence generation. Ongoing 

implementation of the Unique Device Identification (UDI) system also will enable NEST to perform 

enhanced analyses of devices on the market, providing a clear and standard way to identify devices in 

electronic medical records. 

CDRH is already relying on RWE to approve new devices, expand the indications for already marketed 

devices, and reduce the time and cost for device makers to meet their postmarket study requirements. In 

2016, CDRH documented access to more than 28 million electronic patient records (from national and 

9 
21 


25747.011

international clinical registries, claims data, and electronic health records) that included device 

identification and awarded $3 million to the Medical Device Innovation Consortium to establish the NEST 

Coordinating Center. 

to 

Timely access to innovative medical technologies has been identified as a significant issue in the delivery 

of high quality health care. Manufacturers of innovative medical products have said that after undergoing 

the FDA approval process the availability of their products to consumers is often slow because, in order to 

obtain coverage and payment from third-party payers, the manufacturers must go through a second 

review process by such payers. Therefore, CDRH established the Payer Communication Task Force (PCTF) 

to facilitate communication between device manufacturers and payers to shorten the time between FDA 

approval or clearance and coverage decisions. By communicating earlier, manufacturers may design their 

pivotal clinical trials to produce both the data required for regulatory approval or clearance, and positive 

coverage determinations. 

To support these efforts, CDRH and the Centers for Medicare & Medicaid Services (CMS) began to pilot 

an approach in 2011 called Parallel Review that would give eligible device makers the voluntary option for 

CMS to start their national coverage determination process while the device is under review by CDRH. 

This process serves the public interest by reducing the time between FDA marketing approval or 

clearance decisions and CMS national coverage determinations. In 2016, CDRH and CMS established 

Parallel Review as a permanent program. Last year, CDRH also established an additional opportunity for 

device manufacturers to invite CMS, private payers, or health technology assessment groups (HTAs) to 

join FDA pre-submission meetings to provide early feedback on clinical trial design. 

Our investments are starting to pay off. For example, in 2016, CDRH approved 91 novel medical devicesthe highest number since the advent of the user fee program in 2003. This followed the second highest 

number from 2015, and continued a 7-year trend that has resulted in a marked increase in the annual 

number of novel device approvals since 2009. These novel technologies, which can help improve the 

quality of life of patients, especially those that require day-to-day maintenance and ongoing attention, 

are yielding promising results. In addition, several of these devices are reaching US patients much earlier 

than they would have in previous years. 

110 "Artificial Pancreas" Approximately five percent of diabetics have Type 1 diabetes, also 

known as juvenile-onset diabetes. People with type 1 diabetes have to constantly monitor their glucose 

levels throughout the day and have insulin therapy through injection with a syringe, an insulin pen, or an 

insulin pump, to avoid becoming hyperglycemic (high glucose levels). Working interactively with the 

sponsor from the earliest stages of development to assist in making this technology available as quickly as 

possible while assuring it is safe and effective, CDRH, in 2016, approved the first automated insulin delivery 

(AID) device in the world that Is intended to automatically monitor glucose (sugar) and provide appropriate 

basal insulin doses-what some have called a first-generation "artificial pancreas12." 

15 The Artificial Pancreas Device System 

10 
22 


25747.012

"'Transcatheter Aortic Valve KE~PI!ac:elrnEmt 

About 80,000 surgical aortic valve replacements (SAVR) are performed in the US annually, One-third of 

these patients are at intermediate surgical risk for death or complications, An aortic valve replacement 

that can be inserted through the blood vessels or, in some cases, through the tip of the heart by a 

catheter, rather than through open surgery, could avoid the risks of surgery and provide an alternative 

effective treatment to patients who are in the "intermediate surgical risk" category, 

In 2011, CDRH approved the first TAVR device in the US for patients who are not surgical candidates for 

SAVR, more than four years after the device entered the European Union (EU) market When, in 2016, 

CDRH use for a TAVR device in patients at intermediate surgical 

risk for death or complications, the positive impact of CDRH initiatives was evident The gap between EU 

and US approval for the expanded indication for use was reduced from over four years to only 18 days, 

US Medicare coverage is also a factor in patients' access to devices, For TAVR devices, access to realworld evidence--what NEST hopes to expand-proved to be a valuable asset The US Medicare program 

immediately covered TAVR devices due to the ongoing collection of real-world evidence on these devices 

in a national registry-there was no delay between US approval and access to this technology, As a result, 

more than 25,000 additional patients each year are now eligible for this life-saving procedure, 

n~;tiie::!'IO for National Accurate detection and diagnostics 

health threats, For example, in 2016, CDRH authorized the use of 

fourteen diagnostic tests for virus under our Emergency Use Authorization (EUA) authority-twelve 

tests to diagnose active infection and two tests to assess whether individuals who may have recently 

been exposed to Zika were actually infected, This rapid action provided timely patient access to Zika tests 

before the summer of 2016, when officials detected the virus in the US Since 2009, CDRH has granted 50 

EUAs, reauthorized 19 EUAs, and granted 30 amendments for tests to help meet the country's needs during 

a national public health emergency, such as outbreaks from Zika, Ebola, and H1N1. 

11 
23 


25747.013

Appendix B 

To successfully harness real-world evidence ("evidence from clinical experience") in an efficient manner, the US must 

develop the necessary infrastructure National Evaluation System for health Technology (NEST). 

Supporting Actions 

mechanisms, such as cooperative agreements and access through 

The number of premarket and postmarket regulatory 

decisions that used real-world evidence increased by 85 percent in 

2016. (compared to FY2015 baseline) 

In 2016, CDRH took a number of actions to achieve the goals and targets established for this priority. 

Establish the National Evaluation System for health Technology (NEST) 

multi-stakeholder Planning Board and the Medical Device Registry Task Force issued a series of reports that 

outlined an organizational structure and infrastructure for the NEST Coordinating Center (February 201511!, April201612, 

and August 2015n). In 2016, FDA awarded $3 million to the Medica! Dev"1ce Innovation Consort1um 

the Coordinating Center, and $1 million to other organizations to continue projects that generate realworld evidence on device performance. 

Develop a framework for the incorporation of reai~world evidence into regulatory decision making. 

Issued draft guidance££ to describe how real-world ev1dence may be used to support pre- and postmarket 

regulatory decisions. Final guidance is planned for 2017, 
24 


25747.014

We believe that if CDRH is to successfully achieve a mission and vision in the service of patients, we must interact with 

JS partners and work together to advance the development and evaluation of innovative devices, and monitor 

the performance of marketed devices, 

By September 30, 2016, SO percent of PMA, de 

: novo and HOE decisions will include a public summary of 

2017*, increase the number of 

Supporting Actions 

In FY 2016, 65 percent of PMA, de novo, and HOE decisions 

included a public summary of available patient perspective data. 

Increased by 65 percent the 

number of approved !DEs (pivotal studies only) with patient 

reported outcomes (PRO). Increased to four {from none) the 

number of patient perspective studies conducted by sponsors in 

support of pre- and postmarket regulatory decisions. 

In 2016, CDRH took a number of actions to achieve the goa!s and targets established for this priority: 

Patient Engagement Advisory Committee Cor1vene thr F.ngJgcment Advisorv Committee to high prionty 

too1cs pat1e0t 1np:Jt 1n total productltfecyclc. 

In Progrt>s£·CDRH chartered and began to recruit members for FDA's new Patient Engagement Advisory Committee 

(PEAC). PEAC members wi!! be selected and announcerl in 2017. 

Education and Training Develop education anrl training for CDRH staff and mdustry on the deveiorment and use of the 

trained more than 80 staff members on pat1ent reported outcomes {PRO) and patient preference 

information (PPi), to advance staff understanding and CDRH rev1ew capacity in these areas. 

13 
25 


25747.015

" " 'l:' \i ~ 

~'• ' ' ' ' ~EN111ER fi¥:OR DEXIICES ~NO RADIOUGGIOA~ HE~lli'EH (EDRH) ' ' il!OillEHlJ:l!ll~ SmRAxt:lllJ:C RRi\JRii1llS=20lli@A!lGIJM~tlSI'l!WEN+S , ', j \" !! 0 " 

if \ \ 0 j \ "s " ;," ~ 0 ' 0 "' 

~-"'"''"""' and 0rQ<I111izati~:lm~l "''"''"'I'""'"""' A manufacturer's ability to design and make high~quality, safe and effective devices and CORti's abiHty to provide the 

necessary oversight to assure devices on the market are high-quality, safe and effective wHI increase as manufacturers 

and CDRH embrace a culture of quality and excellence throughout our respective organizations. 

credentials by providing onsite quality training and 

certification examinations. 

''*' 'Goal: strengtllen l!rOlluct ~fid Manuf•ct!l!lng i;:tuali!Y 

J :s" s "":WitHin tlle ~e~Je3toevite, :Etos~tem ,/' ~ 

on a proof-of-concept and 

pilot with three device 

manufacturers, to evaluate 

use of the CMMI appraisal 

process as a foundation for a 

Supporting Actions 

In 2016, CDRH took a number of actions to achieve the goa!s 

and targets established for this priority: 

Quality Management Framework Resources permitting, 

continue to implement the CDRH Quality Management framework. 

Jn Progress: CDRH completed development of 1ts document 

control system (DCS). DCS will ensure that current and approved 

quality program and key processes documentation·-standard 

operating procedures, work instructions, forms, templates and 

process maps-is available to staff. 

Education and Training Develop education and training for 

CDRH staff to facilitate adoption of practices characteristic of a 

culture of quality and organizational excellence. 

in Progress: CDRH became an America1 Sooety for Quality (ASQ) 

enterprise member-enabling every employee at FDA to take 

advantage of ASQ's vast cotfection of learning resources. CDRH also 

offered on~site quality training to 150 staff. More than 90 percent 

of those who participated in the training earned ASQ quality 

cert1f1cations {Certified Quality Auditor and Certified Quality 

Improvement Associate). 

Case for Quality As part of the Case for Quality, collaborate 

with members of the medical device ecosystem to identify, 

develop, and pilot metrics, successful practices, standards, and 

evaluation tools that wtll be specific to the medical deviCe industry 

and focus on assurmg product and manufacturrng quality. 

In Progress: In partnership with MDIC, CDRH collected input from 

stakeholders through six Case for Quality Forums; developed 

metrics and best practices designed to assess quaiity system 

performance using pre-production, production and postproduction data; and led development of a product quality 

dashboard to assist hospital value analysis committees 1n identifymg high quality devices. 

Voluntary Program Identify external partnerships and mechanisms to support a sustainable, voluntary third party program that 

willutilu:e quality metncs, pract1ces, standards, and evaluation tools to assess and promote medical device product and 

rnnnufactunng qunlity within industry bE'yond cornp!iance w1th r-egulatory requirements 

Progress: Continuing partnership with MDIC, CMMIInstitutc and other stakeholders, to expand application of maturity appraisal 

process; with the goo! of developing the framework for a voluntary program in 2017. 

14 
26 

Mr. BURGESS. The Chair thanks Dr. Shuren for his testimony, 

and we will move into the question portion of the hearing. I will 

begin with the questioning and recognizing myself for 5 minutes. 

I do want to stress to Members that we do have a lot of members 

on the subcommittee who are anxious to interact with Dr. Shuren. 

So, let us try to keep our question time to 5 minutes. If necessary 

to do followups afterwards, perhaps we can arrange to do that. 

But, Dr. Shuren, I remember several of these rounds before, and 

I just have to say how optimistic your statement is and how optimistic the approach that your Center is taking to this process. For 

that, I thank you. There is a difference. 

You talked in your opening remarks about a least-burdensome 

approach, and certainly that is something that we heard from a 

number of people at some of these hearings in 2012, that they were 

anxious to see that. 

So, I just ask you, what has changed at your Center culturally 

to allow for things to be so different today than they were 5 years 

ago? 

Dr. SHUREN. I think one of the biggest differences in culture is 

we are putting the emphasis on the other side of our mission. For 

so long, we focused on protecting public health. We also have to 

think about promote public health. It is not just assuring that medical devices are safe and effective, but also that patients have timely access. And we facilitate device innovation. That is what you see 

in our vision statement, and that is why it is so important. That 

first in the world is really not about beating other countries. It is 

about getting timely patient access. That is simply a good metric. 

We have moved towards more of a flexible benefit/risk paradigm 

in how we think about technologies. It helps bring them to market 

more quickly, but appropriately. 

We are factoring in the perspectives of patients. What are the 

values, the tradeoffs, they are willing to make in decisions? And 

now, we are relying more and more on real-world evidence, which 

can be generated in a number of cases in less time and lower cost. 

Mr. BURGESS. Well, you mentioned in your opening remarks 

about the artificial pancreas. And I can remember discussions with 

patient groups and parents and folks who were interested in that, 

the difficulty with getting DS on that. So, I certainly acknowledge 

what a milestone that was. 

I just can’t tell you the relief and gratitude that I have heard, 

particularly in parents’ voices when they say that, you know, ‘‘My 

iPhone alerts when my child’s glucose is getting outside of the prescribed range...’’ and to be able to deliver some measure of control 

back to the patient, back to their caregivers, that is an enormous 

gift. 

Five years ago, I was critical because it was taking too long. I 

am glad that you moved it along. I am glad that it was accelerated. 

I think it underscores what you were saying, that we are not just 

about protecting patients; we have got to deliver for patients. And 

I think the artificial pancreas is probably the No. 1 case that 

makes that point. I welcome the cultural changes, and whatever 

was required on your part to achieve those, I think we are grateful 

for that. 

27 

Now in 21st Century Cures you participated in some of the 

roundtables. I know we had a number in this very room. It was 

configured a little differently, for those who are watching on television, but it was here in the main committee room. 

We heard about patient participation in drug and device development and the product review process. Can you talk about how the 

Review Division staff in the Device Center will now be incorporating patient perspectives into their decisionmaking? 

Dr. SHUREN. We have started that process already. One of the 

areas we started to focus on is, how do you better understand the 

perspectives of patients? I mean, you can ask people, but, you 

know, within that patient population they substratify. So, we have 

been advancing the science of patient preferences. What are the 

tools you can use to more quantitatively assess the tradeoffs patients are willing to make? 

We did this in a study on obesity devices. In 2007 to 2014, we 

hadn’t—— 

Mr. BURGESS. Sir, what type of devices? 

Dr. SHUREN. For obesity. And we hadn’t approved anything from 

2007–2014. When we incorporated patient perspectives, we 

changed our paradigm, we approved a device then. We have approved five more since then. The pipeline is rich. 

So now, what we are doing is we have put out policy on factors 

to consider in doing these studies. Companies are now coming to 

us. We are training our staff. And with MDUFA IV, we will have 

the resources to build a patient engagement program, giving us the 

expertise to provide advice on the design and use of patient preference information, patient-reported outcomes, and better designing clinical trials around patients’ needs and their preferences. 

Mr. BURGESS. I am glad you mentioned that because, of course, 

many of the device manufacturers are very small and perhaps lack 

the resources of their larger counterparts. I am going to submit 

that question for the record, but I am interested in the answer to 

that question. 

In the interest of time, I am going to recognize the gentleman 

from Texas. Five minutes for questions, please. 

Mr. GREEN. Thank you, Mr. Chairman. 

Again, Dr. Shuren, I want to thank you and your staff for the 

progress, because bringing in the patients, the patient advocates, 

it just expands it, and it is much better if everybody is at the table, 

particularly patient advocates who come in with resources and experience that helps you. 

I understand the National Evaluation System for health Technology, or NEST, has the potential to make it less expensive to 

bring new device to market, expand or approve users for existing 

products, and post-market requirements for harnessing real-world 

data collected during the routine care. Can you explain what the 

NEST is and how it is incorporated into the agreement? Specifically, how does NEST differ from the CDRH currently and how it 

will generate value to patients, the FDA, and the medical device 

industry? 

Dr. SHUREN. One of the great inefficiencies we have in our 

healthcare system is that we gather information every single day 

in patient encounters, but we can’t make great use of it because it 

28 

may not be standardized; it may be incomplete; it may be of poor 

quality. And it sits in electronic health records, registries, payer 

claims. 

What NEST is about is, how do you use market-based principles? 

How do you use the collective purchase power of the ecosystem to 

drive towards greater standardization and consistency, drive down 

the time and cost of being able to leverage that information and, 

then, to use it to inform decisionmaking, generate the evidence for 

products to come to market, as well as to meet post-market requirements? 

So, for example, in this past year we approved a device, a balloon 

stent. It was based solely on real-world evidence that came from 

device registries. 

We have expanded labeling indications based on device registries. Companies today are leveraging device registries for their 

post-market study requirements. They are finding a 40-to-60-percent decrease in the cost of those studies. So, it is already having 

an impact. 

What NEST does is it makes it more systematic. Cost goes down 

further, and it can be readily available for more device types and 

more device companies. 

Mr. GREEN. Thank you. 

The 2015 decision time decreased 35 percent. While this is great 

in understanding the most recent MDUFA Quarterly Report, the 

FDA’s time for metrics to review PMA devices went up. Do you 

know what is behind this increase and what sort of tools are included in the new MDUFA agreement that would help prevent 

these sorts of total time increases in the future? 

Dr. SHUREN. We are starting to see a little bit of an upturn, 

which is why it is so important that you are monitoring the data 

constantly. We are in the midst of doing a deeper dive and we are 

looking at a variety of factors. One is the increased workload that 

we saw under MDUFA III, and particularly for the most innovative 

devices, like PMAs and de novos. 

So, in fact, one of the contributors might be the success of the 

program is leading to the more innovative, more complex technologies coming to the U.S., which is a good time. But we are looking into it and we will take the appropriate action. 

What MDUFA IV will provide is certainly more resources to be 

able to do the work, but I also think do the work more efficiently 

by building in a quality management system to help us drive towards improving our processes, reduce waste, lower cost, and improve the effectiveness of our programs. 

Mr. GREEN. And, of course, while we are working on MDUFA, if 

you have any suggestions for it? I know there has been a partnership over the last number of months, and years even, to working. 

But, if we can help that, what we need to do with this legislation, 

just please let us know. And that is really a bipartisan issue. 

I know digital health is a key area and focus for FDA. I want 

to thank the agency for its work with us in the last Congress. Advances in technology have potential to transform medical care, ensuring FDA has the right tools in place to ensure patient safety, 

and appropriate oversight of the category of devices as a goal. Software as a medical device and software inside medical devices are 

29 

two specific addressed in MDUFA IV. Can you talk about the commitment has to build expertise and enhance the review process for 

such software? 

Dr. SHUREN. Well, one of the key components of MDUFA IV reauthorization would be to establish digital health units centrally 

within the Center to help drive rate of coordination and consistency. The way we will set this up is that our review staff who deal 

with software as in medical devices, they will get basic training. 

They will sort of be yellow belts. They will deal with more general 

issues. 

Then, within the offices, we will have better trained people, kind 

of the green belts. You can think about this Digital Health Unit. 

These are the black belts who get involved in the more challenging 

submissions who can oversee training, assure consistency. 

But the other part of this agreement is to continue our international harmonization work and the International Medical Device 

Regulators Forum, IMDRF, which is critical, driving more international harmonization, but also revisiting the paradigm. So, we 

are looking to change the paradigm on software as a medical device 

to better meet the rapid innovation cycles we see in these technologies. We are working collaboratively with others on trying to 

establish that new paradigm. 

Mr. GREEN. Thank you, Mr. Chairman. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. 

The Chair recognizes the gentleman from Michigan, Mr. Upton, 

chairman emeritus of the committee. Five minutes for questions, 

please. 

Mr. UPTON. Thank you, Mr. Chairman. 

And, Dr. Shuren, thank you. Jeff, thank you very much for all 

your participation. You were really terrific as we moved 21st Century Cures to the goal line. Your participation in this room and as 

part of a number of roundtables, your participation around the 

country in roundtables was very important, and we really appreciated all your work on that. 

You give us some really good news in terms of the progress that 

you have made over the last 5 or 6 years. It reminds me of when 

I was going through a major facility in our district, Stryker, years 

ago, before this process really started. I can remember going with 

the then-chairman of Stryker looking at a 6-, 7-hundred-thousandnew-square-foot manufacturing facility in Michigan. And I said to 

him, I said, ‘‘Jeff,’’ I said, ‘‘what do you think?’’ And he said, ‘‘I just 

wondered if we should have built this in China.’’ 

And that was because we were lagging behind. We didn’t have 

these approval rates like we have now. You could talk about the 

artificial pancreas approval 3 years ahead of what the experts 

thought would happen; it is really great news. Because not only are 

we seeing those benefit the patients that need them, but I have got 

to believe that that is going to be built here in the U.S. That is 

going to be the jobs that we all want, the high-tech jobs that are 

going to be there that we all want. 

So, I guess your colleague Dr. Woodcock was here about a week 

ago. She talked about, if we don’t get this done, heaven forbid, but 

if we don’t get it done and send the signal probably by the end of 

30 

June or July, the end of July, that they would expect that they 

would perhaps a 70-percent reduction, and they would have to 

start sending out RIF notices to folks. We are going to do everything we can to make sure that that doesn’t happen, that we are 

going to work together to get it done. 

But what would be the impact and what is the timing as it relates to PDUFA for your large chapter of where we want to head 

as well? What is the latest that you need to hear from us? 

Dr. SHUREN. Well, first, let me take the moment to thank you 

and Congresswoman DeGette, and all the members on the subcommittee and on the committee, for your leadership in the 21st 

Century—— 

Mr. UPTON. We didn’t lose a one, I want you to know. It was 

unanimous in this committee, thanks to the leadership on both 

sides. 

Dr. SHUREN. So, the impact and the timing for us, if MDUFA 

were to sunset, not get reauthorized in time, we would lose about 

a third of our staff. As Dr. Woodcock said, it is about 60 days before that law sunsets that we need to start the process on a reduction-in-force, RIF. 

So, it has huge implications, and it is not just even the people 

you lose, but for the people who remain. Your best and your brightest leave because they see it is a sinking ship and they are going 

to get off and move on to other things. 

So, it is our hope that we would have the law reauthorized before 

we need to start that process for a RIF. 

Mr. UPTON. So, my next question is, great news about the artificial pancreas, and we have been watching that a while and what 

it would do, and particularly to the diabetic community across the 

country. 

What are some of the devices that you have in the pipeline that 

you think may be—you know, assuming that things go well, tell us 

a little bit about that next chapter. What are some of the things 

that you see on the horizon for us getting done? 

Dr. SHUREN. Well, you know, I think where technology is going, 

you are going to see more and more use of robotics. You are going 

to see technology get smaller and smaller, you know, micro-sized. 

You are going to see less-invasive surgeries happening. 

Another great example is on the transcatheter aortic heart valve. 

When we first approved it here, it was 4 1A1⁄2 years after it came 

CE-marked in Europe. This past year we just approved expanding 

use in another population. It was 18 days after Europe for similar 

technology. 

But we are going to see other things like using maybe 

ultrasound, instead of a scalpel, ultrasound that drives down to 

start to do surgery under the skin. So, there are amazing things 

that have happened. And I think the U.S. can truly be the world’s 

leader if we continue on the trajectory we have been on. 

Mr. UPTON. Thank you. Thanks again for your work, and we look 

forward to working with you in the days ahead. 

I yield back my time. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. 

31 

The Chair, then, recognizes the gentlelady from California, Ms. 

Eshoo. Five minutes for questions, please. 

Ms. ESHOO. Thank you, Mr. Chairman. 

And welcome back, Dr. Shuren. It is good to see you. 

I want to commend you and your entire team for the report that 

you have brought forward. It contains a great deal of good news, 

and that good news affects patients, No. 1, I think. It is a compliment to you and the industry for the work that you have done 

together. 

This is a very important American industry. We want to keep it 

that way and keep it vibrant. I can’t help but, as the mother of 

MDUFA—it was my legislation that created this process—it is 

deeply gratifying to see how it has really come along, and that we 

are where we are today. So, bravo to you. 

I also want to thank you for meeting on a quarterly basis with 

Congressman Erik Paulsen and myself, as co-chairs of the Medical 

Technology Caucus. We have done this for some time. We bring up 

the issues just the way they are presented to us by constituents, 

by patients, and I hope that you think that those meetings have 

been as rewarding as we do. And we are very grateful to you for 

that. 

How much money is in the user fees for this go-around, for this 

reauthorization? 

Dr. SHUREN. So, for this reauthorization, without adjusting for 

inflation, the total over the 5 years would be about $999.5 million. 

Ms. ESHOO. And it is adjusted for inflation as opposed to what 

you are operating under now? Or did the industry come up with 

more? 

Dr. SHUREN. MDUFA III also was adjusted for inflation, too, for 

over time. 

Ms. ESHOO. And how many staffers do the user fees pay for? 

Dr. SHUREN. So, currently, if you just said—— 

Ms. ESHOO. I think you said, what, a third of the—— 

Dr. SHUREN. Yes, so it is about a third of—— 

Ms. ESHOO [continuing]. A third of your Division? 

Dr. SHUREN. If you were paying for full salary, in reality, the 

number of people who work in the User Fee Program in one way, 

shape, or form is probably a little over 90 percent of the program. 

Ms. ESHOO. Well, I think every member of this subcommittee, 

and hopefully the full committee, will have a deep appreciation of 

that. 

No. 1, I think the negotiations that you have completed should 

be accepted by the Congress. I mean, it has been worked out. I 

don’t think there is anything to meddle with, unless Members have 

something that they think needs to be brought up. But I think that 

this is ready for primetime. 

So, I don’t have anything that I want to add to it. What I would 

like to know is, I know that the FDA participates in the International Medical Device Regulators Forum. I know it is a voluntary 

body of device regulators around the world to talk about future directions in the medical technology world and in regulatory harmonization, which I think is very, very important because these products end up being global. 

32 

What can you tell us about that? What is news with it? Where 

do you see things moving? What are some of the activities that the 

FDA is working on in this area? And then, of course, the operational question around here always is, what else do you think 

needs to be done? 

Dr. SHUREN. So, the latest is in the past year we officially stood 

up medical device single audit programs, so a surveillance inspection conducted by one participating jurisdiction is relied on in 

whole or in part by another jurisdiction. So, that reduces a lot of 

cost to companies. You have fewer inspectors coming in the door. 

It is good for Government because we have a broader view of the 

facilities out there. 

Our work is advancing on harmonizing international regulation 

on software as a medical device. We are doing work to advance the 

use of standards, international and national standards, very important for also driving down time and cost and greater consistency. 

And the next place where we are just starting in, and I think will 

be the biggest project we have taken on, is pulling the building 

blocks together to, hopefully, establish a Medical Device Single Review Program, where the approval decisions by one participating 

jurisdiction, again, are relied on in whole or in part by another jurisdiction. That would probably be one of the most fundamental 

changes in the medical device arena. And if there is anything that 

is going to push a least-burdensome approach, it is that effort. And 

the U.S. is the one who proposed it and we are the ones who are 

leading it. 

Ms. ESHOO. Bravo. Thank you very, very much, and to your entire team. Great to see you. 

Thank you, Mr. Chairman. 

Mr. BURGESS. The gentlelady’s time has expired. The gentlelady 

yields back. 

The Chair recognizes the gentleman from Pennsylvania, Mr. 

Murphy. Five minutes for questions, please. 

Mr. MURPHY. Thank you, Mr. Chairman, and thank you, Dr. 

Shuren, for being here. 

A recent survey found that the majority of Americans believe 

that proper servicing and maintenance of medical and radiationemitting electronic devices is crucial to protecting patients, and 

that all medical services should be consistently regulated by the 

FDA, regardless of whether they are an original equipment manufacturer or a third party. 

Can you give us some update on where things stand on rules for 

third-party service of medical devices in order to ensure this safety? 

Dr. SHUREN. Yes. Well, we agree both that we need safe servicing, but also the importance of having good servicing available. 

We held a workshop back in October of last year, and we heard a 

great input from the original equipment manufacturers as well as 

from the third-party servicing industry, from patients, and from 

others. Right now, we are still going through the feedback we received, and we still have groups who are coming in and talking to 

us. So, we are still in the data-gathering mode at this point. 

Mr. MURPHY. Do you anticipate any dates by which you are going 

to have some resolution of this? 

33 

Dr. SHUREN. I don’t at this point, and this is also an issue that 

we will be discussing and working with our colleagues at HHS on. 

Mr. MURPHY. But you agree with the general concept that you 

have to make sure that services are more or less approved in going 

through with this? 

Dr. SHUREN. We do want to make sure that they are of high 

quality, and we heard issues on both sides, both from the original 

equipment manufacturers, the importance of having people who are 

well-trained, using appropriate parts. We also heard from the 

servicers, making sure that they have access to the right training. 

Couldn’t they get the parts that they needed? 

So, finding sort of what is the best path forward to address concerns and make sure we have a safe, but rich environment out 

there will be important. 

Mr. MURPHY. Thank you. I look forward to getting updates from 

you on that. 

Next, I just want to talk this global economy here. I am interested in ways we can harmonize regulatory processes around countries, so the companies can realize efficiencies and patients can 

have access to lifesaving devices in a more timely manner, part of 

what was approached in 21st Century Cures. 

But I want to know about harmonization efforts here that you 

are working on or that you would ask Congress to consider. Could 

you comment on some of those? 

Dr. SHUREN. Well, I think the big one that allows that sort of 

fast-to-our-patient access is this Medical Device Single Review Program. We just put in place policy under this International Medical 

Device Regulators Forum, IMDRF, for competency, training, and 

conduct of third-party reviews. So, that is the very first building 

block. 

We just adopted a new work item to revisit sort of a foundational 

document that we call the Central Principles on Health and Safety, 

and safety and performance, that we will be working on next. 

So, it is going to take a little bit of time. There are other issues, 

too, related to harmonization that we will need to tackle as a country. And it is things that we are in discussion with HHS about, and 

I hope we have an opportunity to maybe discuss again when there 

is more information to provide. 

The last piece is MDUFA IV also provides greater support for a 

more robust third-party review program, which is going to be important if we are ever to get to the place of that harmonized single 

review program. It is not just about more efficiencies domestically, 

but it can give us a leg up for moving to truly a global medical device review program. 

Mr. MURPHY. Thank you. 

Next, I want to talk about security, more particularly, more specifically, cybersecurity as it relates to the privacy of the records of 

devices, of manufacturing, et cetera. But it frequently comes up in 

the context of these medical technologies. How has FDA been engaging in this issue about cybersecurity with devices? 

Dr. SHUREN. So, to date, we have put out several policies on cybersecurity, both on the pre-market and post-market. We have 

been adopting national and international standards. We have been 

working with other agencies, particularly with the Department of 

34 

Homeland Security through their ICS–CERT, with the Department 

of Commerce, with FTC, and with the HHS Cybersecurity Working 

Group. 

One of our more recent efforts is an MOU with the NH–ISAC, 

the National Health Information Sharing and Analysis Center, to 

establish what we call an information-sharing and analysis organization. It is essentially a community that allows sharing amongst 

members in the device ecosystem about vulnerabilities and about 

safeguards to take. 

This is a critical part about cybersecurity. It is a shared responsibility. It doesn’t fall to one entity. And we need the members of the 

ecosystem sharing information, working what we call researchers, 

the white hat hackers, so we can identify what are the 

vulnerabilities and put in safeguards, recognizing that because the 

people who hack, they get smarter and smarter, and the risks continue to evolve. You have to constantly keep up on this. So, you 

need that kind of active forum. 

Mr. MURPHY. Thank you, Mr. Chairman. I will submit the rest 

of my questions for the record. I yield back. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. 

The Chair now recognizes the gentlelady from Colorado, Ms. 

DeGette. Five minutes for questions, please. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

First of all, I would like to add my thanks, Dr. Shuren, for the 

approval of the artificial pancreas, on behalf of the Diabetes Caucus, but also on behalf of my family because, as you know, my 

daughter is a type 1 diabetic and will be one of the first users of 

this. So, thank you very much. 

I want to talk to you a little bit about some of what President 

Trump’s Executive Orders are doing to the agency and what this 

will mean for the implementation of 21st Century Cures. Because 

we are all having what we feel is a much-recognized bipartisan 

lovefest around our great committee achievement last year, and we 

are really proud of it and what it has done in the medical device 

arena. But we are concerned about, at least I am concerned about 

some of the announcements emanating from the administration. I 

would like to get some clarification from you, if you have some. 

Some of us sent a letter to the administration a couple of weeks 

ago about the hiring freeze. And we are concerned in the medical 

device arena that the hiring freeze will stop us from hiring the 

right people that we need to implement the bill. And we are awaiting a response for that. 

But there is another issue that also I think threatens Cures and 

the user fee implementation. That is President Trump’s repeated 

calls to deregulate the FDA. A couple of weeks ago, he said he 

wants to cut up to 75 to 80 percent of all FDA regulations. 

And the problem I have, you know, nobody likes unnecessary or 

overly burdensome regulations. Nobody ever, ever wants that to 

happen. But what the President seems to do is he sort of seems to 

do this with a meat axe. So, for example, he had issued this Executive Order saying that, if you are going to have a new regulation, 

then you are going to drop two regulations without looking at what 

the arena is that you are talking about or what the regulations are. 

35 

And I think this is of particular concern with the FDA when it 

comes to agency guidance because, when you guys issue agency 

guidance, then that helps the stakeholders understand how the 

FDA is implementing and interpreting the rules and laws. Even 

when the stakeholders don’t agree, at least they know where you 

are coming from. 

And so, I am concerned, if you have this repeal two for every one 

you adopt, then that is going to also—not only is it going to hurt 

with the agency guidance, but it is going to help with many of the 

provisions for 21st Century Cures. The breakthrough device pathway is a really good example. And the CLIA waiver provisions in 

Cures, they call for new guidance. So, how are we going to drop two 

if we are enacting one? It is also going to complicate issuance of 

guidance documents under MDUFA IV, such as third-party review. 

So, my question to you, has the Trump administration clarified 

to the extent to which an Executive Order applies to a guidance 

issued by an agency? 

Dr. SHUREN. Well, first of all, I will say we recognize the importance of issuing appropriate guidances and regulations. 

Ms. DEGETTE. Right. 

Dr. SHUREN. Right now, we are working with our colleagues at 

HHS on implementation of the Executive Order. But I can tell you 

we are already moving forward to implement 21st Century Cures. 

Just a few weeks ago, we put out a notice of medical devices that 

are Class II that we are proposing should no longer have to submit 

at 510(k). 

Ms. DEGETTE. That is great. 

Dr. SHUREN. And that, you know, we will look at public comment, but that would deregulate, if you will, over 1,000 medical devices. So, we are already moving forward on those. 

Ms. DEGETTE. So, you are trying to work with HHS on interpreting what that Executive Order means at this point with respect 

to guidances? 

Dr. SHUREN. Yes. 

Ms. DEGETTE. OK. Now, if you are not able to issue new guidances, will the Cures implementation be impacted by that? 

Dr. SHUREN. Yes. 

Ms. DEGETTE. Breakthrough devices is the perfect example. 

Dr. SHUREN. That is correct, because we are called on in the statute to also issue certain guidances. But, again, as of right now, we 

have been able to put in place the things we need to do to meet 

statutory deadlines and—— 

Ms. DEGETTE. That is good. Will you please let us know if you 

start seeing impediments to implementing 21st Century Cures because of this? And I know we can work on both sides of the aisle 

to make sure that the implementation goes smoothly. 

Thank you. 

Thank you very much, Mr. Chairman. I yield back. 

Mr. BURGESS. The gentlelady yields back. The Chair thanks the 

gentlelady. 

The Chair recognizes the gentleman from Indiana, Dr. Bucshon. 

Five minutes for questions, please. 

Mr. BUCSHON. Thank you, Dr. Shuren, for being here. 

36 

I am interested in bringing more predictability and consistency 

to the device inspections process. It is a little bit off the beaten 

path. But, for routine inspections, the FDA should be able to give 

companies a reasonable heads-up about what they are inspecting 

as well as provide regular communications throughout the inspection. I think you probably agree with that. 

Additionally, should the FDA find an issue that needs to be addressed during an inspection, companies have 15 days to submit a 

remediation plan to FDA, but there is no such timeline for the FDA 

to respond to companies, to communicate whether the remediation 

plan meets FDA expectations. 

Can you comment on what CDRH might be able to do to address 

these issues? 

Dr. SHUREN. Well, although we are not the lead on this—our Office of Regulatory Affairs oversees the fields—we do work very 

closely with our colleagues over in ORA. And I can tell you, as a 

part of the program alignment effort, which is getting officially 

stood up in the coming weeks, as part of that, I know ORA—and 

we will be working with them—is looking to revisit their standard 

operating procedures and other processes to make device inspections more efficient, more timely, and to have the right kind of engagement back with the companies. 

Mr. BUCSHON. Great, and I think that is important that you do 

engage in that process really to try to improve everything across 

the spectrum as it relates to the device industry. 

My colleague Ms. Brooks and Mr. Butterfield and Mr. Peters introduced legislation yesterday to try to address some of these 

issues. And so, I look forward to working with everyone on trying 

to improve that situation. 

Mr. Chairman, I yield back. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. 

The Chair recognizes the gentlelady from Florida, Ms. Castor. 

Five minutes for questions, please. 

Ms. CASTOR. Well, thank you, Mr. Chairman, for calling this 

hearing today. 

And welcome, Dr. Shuren. 

Patients understand better than anyone about the impact treatment will have on their daily lives, and they have a unique perspective to add, as the benefits and risks of different treatments 

are considered. There has been considerable interest from the patient community and families in incorporating the patient perspective into both the drug and device regulatory review process and 

the development process. 

Dr. Shuren, please discuss how the proposed MDUFA IV agreement works to further incorporate the patient perspective into the 

medical device regulatory process. And if you would, give us a few 

examples. 

Dr. SHUREN. Well, it will build on work that we have done to 

date and establish sort of a patient engagement program within 

CDRH; allow us to have the expertise we need to provide greater 

advice and abilities in reviewing studies that are conducted to assess patient preferences, to advance the incorporation and the voluntary use of patient-reported outcomes, so we are measuring the 

37 

things that matter the most to patients; how we more systematically incorporate the perspectives of patients in the design of clinical trials. We have to design studies not around the needs of the 

investigators, but the lifestyles of the patients who participate in 

those studies. 

This is a journey we have been on now for over 5 years, starting 

with our Benefit-Risk Framework we put in place for product approvals back in 2012, where we made a decision that we would explicitly make a factor in our decisionmaking to be patient preferences. 

The old way of saying that we take into account the tradeoffs our 

reviewers make is not what we should do. Devices are used on or 

in patients. And so, the tradeoffs they are willing to make are the 

ones that should factor into our decisionmaking. And MDUFA IV 

will help us advance that work. 

Ms. CASTOR. And you provide a few examples when a patient organization had some ideas and came to you and how it improved 

the situation or altered the situation? 

Dr. SHUREN. Yes. So, one, I had mentioned this study we had 

done with obesity treatments. That has already led to now products 

coming on the market. We are looking to replicate that in other 

areas. 

The other thing patient groups have done—and we have set this 

up—is getting them to come in and speak to everyone in our Center. I believe every single person in CDRH needs to be interacting 

with patients. That is even our secretaries. So, when they answer 

the phone, they return an email, they understand the patient’s perspective when they do so. 

So, last year we hosted 21 events for our staff in our Center, and 

34 patient groups participated in that. We are establishing mechanisms where we now have, rather than just a network of scientific 

and engineering and healthcare professional experts which we set 

up, we have a network of patient groups, patient volunteers who 

are working with us. 

And then, the next stage this year is the official launch for our 

Patient Engagement Advisory Committee, where for the first time 

at the agency there is an advisory committee made up just of patient representatives to tackle the issues that matter most to them. 

Ms. CASTOR. Great. I appreciate your emphasis on that, and we 

will be following up with some more specific questions. Thank you. 

Mr. BURGESS. The gentlelady yields back. The Chair thanks the 

gentlelady. 

I now recognize the gentlelady from Indiana, Ms. Brooks. Five 

minutes for questions, please. 

Mrs. BROOKS. Thank you, Mr. Chairman, and thank you, Dr. 

Shuren, for being here. 

In the information you provided us in your written testimony, 

you talked about the diagnostics for national emergencies. I would 

like to focus a little bit on that because I have been focused here 

on trying to strengthen our public health infrastructure for national emergencies, but I have been more focused, along with Congresswoman Eshoo, on incentivizing vaccines and treatment for 

public health emergencies and pandemics. But I know from your 

testimony that, obviously, the diagnostic piece and the testing iniVerDate Mar 15 2010 10:41 Oct 19, 2018 Jkt 037690 PO 00000 Frm 00041 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X20USERFEES\115X20USERFEESWORKING WAYNE
38 

tially is so very critical, and I appreciate the rapid response that 

has been undertaken by FDA and applied the high volume of the 

emergency use authorizations granted and reauthorized. 

But, unfortunately, as we know, whether it was Ebola in 2014 

or, most recently, Zika virus in 2016, we know that FDA has focused significant time and resources to these diagnostics. But can 

you speak not just to what has happened in the last 5 years, but 

what can we anticipate going forward from CDRH? Because I know 

there is a lot of concern when we have these outbreaks, I know as 

we get ready to go into the warm season once again with Zika, we 

don’t have vaccines yet. We don’t have treatments. 

Can you please share with us with respect to national emergencies what your offices, what the focus is, whether or not the resources that we have been providing are sufficient? What more 

should we be doing? 

Dr. SHUREN. Well, certainly on the device side for diagnostics, we 

have sort of invested in our infrastructure to try to best handle, 

when there is an emergency, that we have the capacity to be able 

to deal with new diagnostics that may be coming in. To date, we 

have already authorized about 50 EUAs, and, also, in a fairly rapid 

time. You know, the median time to approve an EUA for Zika was 

about five days. 

Mrs. BROOKS. Excellent. 

Dr. SHUREN. The other thing that we do in these circumstances 

is we develop templates for the product developers that make it 

easier for them to be able to gather the evidence under that standard, get it to the agencies. So, again, this moves much more quickly. 

I would say the greatest challenge developers face today is more 

about access to samples and the clinical information linked to that 

sample. It is not under FDA’s purview, but that is what we hear 

from the companies, because the samples help them design the 

technology and, then, validate it. 

More broadly, when we deal with these national emergencies, it 

is certainly an issue—I know your interest—I will take back, but 

it really is sort of a question about more on the national level, are 

we prepared as a nation? And I will ask this rhetorically, because 

I am not the one to answer it, but are we prepared as a nation 

when we have the next outbreak? Because there is going to be a 

next outbreak. As we see, we are just constantly bombarded with 

new organisms and things that really stretch our scientific knowledge and capabilities. 

Mrs. BROOKS. Well, and thank you for that. It is reassuring, actually, to hear that it was only a five-day turnaround with respect 

to Zika. 

It kind of leads into my next question about global harmonization. If you say that you don’t have enough samples, what kind 

of cooperation is there and what kind of harmonization is there between our partners in other countries? With their regulatory process and our own, how can we possibly work on that to help particularly with emergency use? 

Dr. SHUREN. I know already that there is strong relationships between CDC, who normally handles that aspect, with other organizations internationally, like the World Health Organization. We 

39 

certainly, then, work very closely with CDC. And when there are 

needs for making available more samples, we will also go to them 

and sort of encourage can we get and make those available to developers. 

Mrs. BROOKS. So, you don’t need authority beyond what you have 

to work with other regulatory bodies? You feel like you have sufficient authorities in place? Or is there anything that impedes your 

work with other regulatory bodies? 

Dr. SHUREN. I think we have the authority we need for the kind 

of work we do. When you think more broadly in terms of the response, when we deal with samples and others, I would say that 

may be questions to direct to the other involved agencies. And certainly, that is something we will take back within HHS. If there 

are any additional needs that HHS feels are warranted for the 

other agencies, we will bring that back to you. 

Mrs. BROOKS. Thank you for your work. 

I yield back. 

Mr. BURGESS. The Chair thanks the gentlelady. The gentlelady 

yields back. 

The Chair recognizes the gentleman from North Carolina, Mr. 

Butterfield. Five minutes for questions, please. 

Mr. BUTTERFIELD. Thank you very much, Mr. Chairman. It is 

good to sit next to you. And thank you so much for calling this 

hearing today, and thank you for your friendship and thank you for 

your leadership. 

The medical device industry, Mr. Chairman, is important certainly to all of us, and including my constituents down in North 

Carolina, both in the Triangle area and in the eastern part of my 

State. Because this industry actually is a job-creator. They employ 

thousands of my constituents. But, also, because medical devices 

can help improve health outcomes and improve the quality of life 

for many lives of those suffering from complex medical conditions. 

My home State is home to many large and small medical device 

developers like CVRx, which I understand is on the next panel, 

which is represented here today. The advances made possible by 

the User Fee Agreement III, including increased communication 

with patient and consumer organizations is a step in the right direction. It is a step in the right direction for transparency and patient involvement in the process. 

Meaningful reforms included in the negotiated agreement for 

MDUFA IV will further advance those goals and stand to improve 

outcomes for patients. Specifically, the potential benefits of using 

real-world evidence to help develop medical devices can benefit my 

constituents and citizens throughout the country. 

Also, the proposed National Evaluation System for health Technology, known as NEST, can help ensure the use of real-world evidence is scientifically based and effective. There is great potential 

for this agreement to facilitate innovation and improve health outcomes. However, the potential can only be realized if the administration invests in the overall budget of the FDA, does not hamstring its mission through hiring freezes. 

Now, Dr. Shuren, I am going to ask you a couple of questions. 

I am going to ask you about the funding at the agency. I think we 

40 

know the circumstances there. That is our jurisdiction. So, we are 

going to deal with that politically on this end. 

But I am very interested in the NEST proposal and the agreement. Can you discuss how stakeholders will be chosen to own and 

operate NEST? And will patient advocacy groups be included in 

that process? 

Dr. SHUREN. Certainly. So, NEST, again, it is a nongovernment 

system; it is a nongovernment entity. And it does not own or control the data sources. It is setting up agreements and policies regarding use of data that may be owned, let’s say, by healthcare systems or by a registry. 

We have already supported the creation of what we call a Coordinating Center. The Medical Device Innovation Consortium, a public/private partnership, is serving in that capacity. They now have 

put out a call for members of a governing committee that would be 

representative of the ecosystem. Patients will be represented on 

that governing committee. So, they are going to have a say in how 

NEST is run, and we are now in the process of hiring an executive 

director. MDUFA IV will provide additional support to now operate 

the Coordinating Center and invest in pilots. 

Beyond the governing committee though, the plans are to establish other forums for different communities. So, looking for beyond 

having those representatives from the patient community on the 

governing committee, forums for the patient community to engage 

directly with NEST and to have their input taken into account. 

Mr. BUTTERFIELD. Under the NEST proposal, what steps do you 

envision for bringing new devices to market? 

Dr. SHUREN. Well, I think one of the critical is your device needs 

to be safe and effective, which you may demonstrate directly with 

high-risk devices or, you know, lower-risk ‘‘me, too’’ devices. It is 

substantial equivalence. 

But it is the science that drives that decisionmaking. And the 

question is, when you need clinical data, the cost to do a traditional 

clinical trial is very, very high. If you are able to leverage data that 

is already being collected, it is a good enough quality, and you can 

control for other biases, then that data can be leveraged to support 

that product coming to market in ways that let you gather the data 

more quickly and at lower cost. And that leads to technology not 

just getting to market more quickly, because the time to develop 

the evidence goes down, but the amount you have to invest to do 

it means you can put that money to develop other products. 

Mr. BUTTERFIELD. Running out of time, my last question, what 

steps do you envision for the expansion of indications for already 

approved devices under the agreement? 

Dr. SHUREN. Again, being able to leverage those data sources 

may allow us to expand a labeling indication. And we have already 

done that, for example, in the case of a transcatheter aortic heart 

valve. The company was planning to do a clinical study to expand 

its indications. We looked at the registry data and said the data 

is already there; why don’t you just ask us to expand the indication? So, what would have taken years took weeks. 

Mr. BUTTERFIELD. Thank you. I yield back. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. 

41 

The Chair recognizes the gentleman from Oklahoma, Mr. Mullin. 

Five minutes for questions, please. 

Mr. MULLIN. Thank you, Mr. Chairman. 

Doctor, thank you for being here. 

During the series that we have been going through, we had a 

hearing about our generic drug user fee, and I got an opportunity 

to talk with Dr. Woodcock about the concerns we have heard from 

industries about the inconsistency with the FDA inspections. Companies are concerned about the lack of transparency, predictability, 

and efficiency, and consistency. And I hear that the inspections of 

foreign device establishments are often more efficient than domestic inspections. Have you heard about this? 

Dr. SHUREN. Yes, I have. 

Mr. MULLIN. Could you explain maybe what steps you are taking 

to make sure that there is consistency through standard operating 

procedures? 

Dr. SHUREN. So, we are working with our Office of Regulatory 

Affairs, who is actually responsible for the field staff. It is true that 

domestic inspections may take longer than foreign inspections. 

Mr. MULLIN. Why is that? 

Dr. SHUREN. So, for foreign inspections, they are making arrangements for that inspector to go over for that inspection. So, 

that is all they are there for. They come back. 

On the domestic side, that inspector may be finishing up with 

another inspection or they get called away for a for-cause inspection. That said, on average, most domestic and foreign inspections 

occur in four days or less, sometimes within one day. But I do 

know that ORA—and we are working with them as part of this 

program alignment effort—is revisiting its SOPs, so that it reduces 

the time for domestic inspections. 

I think folks understand it can be disruptive to companies. Someone comes in the door, they leave, they come back, rather than they 

come in and they finish their work, they are done, and they move 

on. 

Mr. MULLIN. So, paraphrasing what you said, the issue we are 

having here domestically versus foreign is that they are distracted? 

Dr. SHUREN. Is? Excuse me? 

Mr. MULLIN. They are distracted? 

Dr. SHUREN. That they may be doing more than—— 

Mr. MULLIN. Well, I mean, what I am saying is that they can go 

over there and they can focus on one task. And when they are here, 

they are focusing on 15 or 20 different tasks? 

Dr. SHUREN. Well, not from 15 or 20, but when they—— 

Mr. MULLIN. Two or three, four or five? 

Dr. SHUREN. Maybe or they may be focused on the one. Like I 

said, most of the time they are doing that inspection in just a few 

days. 

Mr. MULLIN. Do the same individuals inspect foreign and domestic? Or do you have a certain group that only does foreign and a 

certain group that only does domestic? 

Dr. SHUREN. As of right now, there are some individuals who, a 

very small number, who do primarily foreign, but many of them 

are people who do domestic and foreign. 

42 

Under the program alignment effort, part of that effort is to 

move away from the other challenge, which is inspectors who they 

not only inspect a device company, they inspect a food company 

and a drug company. Program alignment is to establish these more 

vertical commodity-specific programs, so you just have a device inspector and that is all they do. And that will allow them to also 

better focus and have the right expertise and training. And that 

will start to drive greater consistency and more timeliness in the 

conduct of—— 

Mr. MULLIN. How long do you think these changes are going to 

be implemented? 

Dr. SHUREN. To be fully up and running, it will take a few years. 

As of in a few weeks, that official program will be stood up in the 

various commodity areas, and over the next two to 3 years most of 

the pieces will be in place. 

Mr. MULLIN. I guess help me understand why 2 or 3 years. What 

is going to take so long to make the changes? 

Dr. SHUREN. In part, because ORA is responsible for all the product areas. So, they are not just dealing with medical devices. They 

have their program for pharmaceuticals, for human food. So, they 

have to handle all of those, and it is, in part, the huge workload 

ongoing from people are geographically oriented in an organization 

and now is focused within a region instead, to say, I have a national organization where people may be in different places, but we 

run it centrally. They got to standardize the training. They have 

got to change their standard operating procedures. The systems 

have to be, the IT systems have to be changed. There is just a lot 

of work that goes into it. 

Mr. MULLIN. And I completely understand everything you are 

saying. I just can’t wrap my head around, when we see that there 

is already issues going on, why it would take roughly 2 or 3 years 

after the program is stood up to fully implement it. I would like 

to think there is a more efficient way for us to be able to get that 

implemented than its taking 2 or 3 years. Because once you issue 

the SOPs, then it is just a matter of people willing to do their job 

and the training that it is going to take to get it. I mean, if they 

have already been in that field to some degree, then we are moving 

distractions away and it seems like they could be able to be more 

focused on just the job at hand. 

And I say that because I get implementing changes in a big organization, that it can take time to turn the ship around. But our 

companies are struggling, which means that our consumers are 

struggling, which means that we have rising costs, and, eventually, 

it gets passed down to the ultimate person that we are here all trying to help prevent higher costs and get the drugs needed to the 

individual that needs it, the patient. 

So, if there is a way that we can help through this process, as 

I offered my help to Dr. Woodcock, I would offer it to you, too. Any 

way that I can help, this committee can help, or our office can help, 

we want to be helpful because this is important. 

Thank you, sir. 

I yield back. 

Dr. SHUREN. Thank you. And I will just say, you are preaching 

to the choir because having better consistency and being able to 

43 

deal with just a set of individuals, that is easier for my Center as 

well. So, I will take this back. 

And I do know, when they stand up the program, the program 

is organized, but they still have to do all the training and the 

SOPs. That work is yet to come. 

Mr. MULLIN. And I will say your sincerity comes through, 

through body language and tone. So, I really appreciate that. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman for his questions. 

The Chair recognizes the gentlelady from California. Five minutes for questions, please. 

Ms. MATSUI. Thank you, Mr. Chairman, and thank you for holding this hearing today. 

And thank you, Dr. Shuren, for being here also. 

This is the last of three hearings on the User Fee Agreements 

negotiated between FDA and industry. I am glad that all parties 

are satisfied with the outcomes, and I think we have all worked together to ensure that FDA has the resources it needs to continue 

making sure that drugs and devices are safe and effective for 

America’s consumers. 

I am particularly pleased with provisions in the User Fee Agreements that will benefit the rare disease patient community. In 

MDUFA, this includes increased patient engagement. This is perhaps more tangible with medical devices because the size and convenience of a medical device directly impacts patients’ quality of 

life, even if it doesn’t necessarily affect a device’s effectiveness. 

Similarly, I think the additional real-world experience evidence and 

data will help incorporate the patient experience in a quantifiable 

way. 

Dr. Shuren, can you talk about how additional patient engagement, as well as real-world evidence through the NEST program, 

will help advance devices for patients with rare diseases? 

Dr. SHUREN. Well, first, I fully agree with you that those two 

pieces will be important for rare diseases. You know, one of the 

challenges is gathering information and evidence to support that 

that device, in fact, meets the standard for a rare disease coming 

on the market. And it can be very hard to get the patients enrolled 

and in studies. But, if we are able to leverage data that may be 

part of their routine care, then we can maybe get that evidence and 

help bring those products to market and to do so in less time and 

lower cost. 

And by the same token, too, we should be measuring the things 

that really matter most to patients. When we decide is the evidence 

sufficient, because there is always going to be uncertainty in the 

evidence on benefit and risk, then for patients and often with rare 

conditions, they are willing to accept more uncertainty for treatment. And so, we need to be willing to accept that uncertainty, too. 

I think that will help. 

The last plug I will put in is I think 21st Century Cures is going 

to help patients with rare disorders as well, broadening the definition of what constitutes a rare disorder for purposes in medical devices. So, again, thank you to the subcommittee for that. 

Ms. MATSUI. Thank you very much. 

44 

Many patients use medical devices every day, everything from 

surgical plants like knee replacements or pacemaker to wound care 

technology, to lab and diagnostic equipment. In recent years, we 

have seen some headlines about equipment that ends up contaminated or defective. This is generally a post-market problem, meaning that the devices themselves are safe and effective, but that 

something happens at the facility or a hospital that compromises 

that. 

While I understand that MDUFA is meant to address only premarket issues, I think that post-market review is an important 

part of what FDA does to keep us safe. In fact, it is a good reason 

to keep funding FDA using appropriated dollars and not just user 

fees. 

Dr. Shuren, I would like to ask about the NEST program and 

how the incorporation of post-market clinical data, such as patient 

registries, may help ensure that devices are safe and effective 

throughout their life cycle. 

Dr. SHUREN. Well, while in the MDUFA agreement, the commitment letter, we talk about pilots that are primarily pre-market, 

that is because, for purposes of the user fee reauthorization, we 

have to stay within the confines of the scope of MDUFA. However, 

NEST is operated by the independent Coordinating Center, and 

they can and are planning to also look more broadly in terms of 

leveraging for post-market safety. And it can address two of the 

challenges we have today. 

First off, for post-approval studies, we know that patients, once 

a device has been approved, lack incentives to enroll in clinical 

trials. So, clinical trials, often they may not get conducted; they 

may not get finished. In fact, we are making phone calls now on 

some of our 522 studies to encourage people, hospitals and practitioners, to enroll patients. But, if that data is being collected like 

in a registry, as we are finding today, then we get that data and 

we get it in a more timely manner. That is great for the company. 

It is great for patients. It is great for us. 

The other is today, for safety problems, we often rely on adverse 

event reports. That means somebody had to identify that a problem 

occurred and may be associated with a device and take the time 

to report it. And there are a lot of things. You may get information 

that is not right. 

Now, when we move toward larger datasets that will allow us to 

use software tools to try to look for are there particular problems 

and, then, do a deeper dive on it, that ultimately enhances patient 

safety and reduces liability for companies. That is a win all around. 

Ms. MATSUI. Well, thank you, Dr. Shuren. 

And I yield back. 

Mr. BURGESS. The Chair thanks the gentlelady. The gentlelady 

yields back. 

The Chair recognizes the gentleman from Georgia, Mr. Carter. 

Five minutes for questions, please. 

Mr. CARTER. Thank you, Mr. Chairman. 

And thank you, Dr. Shuren, for being here. We appreciate it. 

I am from the State of Georgia. We have got quite a few medical 

device companies in our State, as well as the CDC. So, I appreciated your comments earlier about the relationship with the CDC 

45 

and how you work closely with them. That is very important, and 

we are very proud of the work that they do for our country, located 

right there in the State of Georgia. 

I want to ask some basic questions. OK? I am not going to go 

by my notes that my staff provided me. They do such an outstanding job. But I just want to ask you something. 

I am new to the committee. As I understand this process, it is 

somewhat of a process that is just kind of a speeding-up process, 

if you will, that manufacturers, the medical device companies, 

agree to pay if they can help to get the process sped up. Am I correct in saying that? 

Dr. SHUREN. That has been a main focus without jeopardizing 

the quality of—— 

Mr. CARTER. And that is what I want to ask you. I want to ask 

you—and I want your true opinion here—have there been instances 

where you have looked back and you have said, ‘‘Gee, I wish we 

would have slowed down some. I wish we would have done something else.’’? 

First of all, have there been any recalls of devices that were approved that, through this process, through the MDUFA process, 

have there been any recalls? 

Dr. SHUREN. Yes. 

Mr. CARTER. OK. In those instances, have you asked yourself, 

you know, had we slowed down some, would this have happened? 

Dr. SHUREN. I don’t believe so. That has not come up. And again, 

the way the goals are designed, it is also it is not 100 percent. So, 

we know, too, if we need to take additional time to make a decision, then we will do it in the individual case. I think, if anything, 

if there isn’t enough time, the pressure is, then, we are going to 

say no if there are issues. But the way they are designed is that 

it gives us flexibility that a percentage may go a little bit beyond 

the timeframes. And so, if we do need to take additional time, we 

will take the additional time. 

Mr. CARTER. OK. Well, in those cases where there was a recall, 

I am sure you went back—I would hope you did—and reviewed 

what you did and said, could we have done anything differently to 

have prevented this? 

Dr. SHUREN. So, we do take a look, what was the cause for the 

recall? Was it something that maybe we should have picked up 

when we were doing review? Most of the things are a lot of times 

issues that either come up after the product is on the market. Or 

anytime you review a product and you have the evidence, you don’t 

have 100 percent certainty on the true benefit/risk profile of that 

technology. You would have to study it so in-depthly, you would 

never get a single product out there on the market. 

And sometimes, with more use, you find out there may have been 

some issue in the design that could affect performance, and we 

need to deal with it post-market. 

Mr. CARTER. OK. Let me shift gears here for just a second. The 

President has made it clear that he wants to cut down on regulations. Earlier you heard someone say his Executive Order; you are 

aware of it. You know, for every new regulation that you pass, you 

have got to cut two. 

46 

If, indeed, this President is cutting back, and if, indeed, as I hope 

we do cut back on a lot of regulations, isn’t that going to cut back, 

if you don’t have to follow as many regulations, are you going to 

have to have as many people? Are you going to have to have as 

much of a staff? I mean, should we reauthorize this for 5 years in 

anticipation of you having the staffing levels that you have right 

now for the next 5 years? 

Dr. SHUREN. So, our workload, first of all, continues to go up. We 

have seen that. One of the most popular programs is our pre-submission meetings. That has been going up, like requests, by about 

10 percent a year. And we are seeing more of the innovative medical device submissions come in the door. 

Part of MDUFA IV is a recognition that the program needs additional funding just to keep pace with the work we currently have, 

as well as strategic investments in programs like patient engagement and real-world evidence that can help enhance and speed access to safe and effective devices. 

Mr. CARTER. OK. One last question. I am a pharmacist, currently 

the only pharmacists serving in Congress. A lot of the clinical tests 

that we sell in the drugstores, they are very important to me to 

make sure that what I am selling to a patient is actually legitimate. And I know this is, from what I understand—and again, I 

am new member of the committee—but, from what I understand, 

this has been somewhat of a debate within the FDA about what 

role they should play in approving some of these. 

I will tell my age here. There was a time when I sold Drano in 

my pharmacy and it wasn’t to unclog drains. For those of you who 

don’t know, before we had gender tests, that is the way a lot of people tested to see if they were having a boy or a girl. That is folklore. 

So, I guess my question is, I know that is a big, big discussion 

about the FDA’s role in approving some of these. And I didn’t know 

if you had an opinion on that or not. 

Dr. SHUREN. So, our perspective has been that tests, regardless 

of what is out there, you want tests that are simply accurate, reliable, and clinically meaningful. And that is just good for our patients. It is good for healthcare practitioners. 

Mr. CARTER. Are all of them coming through you? Are you approving all of them? I mean, we had the situation with Walgreens 

and fairness and some of the tests that were being sold there. 

Dr. SHUREN. No, they don’t all come through us. 

Mr. CARTER. Do you think they should? 

Dr. SHUREN. Well, I think that issue is one that we know is of 

great interest to many Congressional Members, to stakeholders, 

and it is a topic that we will talk about with our colleagues at 

HHS. We haven’t had that conversation yet. So, I am just not in 

a position now to talk about it. 

Mr. CARTER. Right. Well, I appreciate it very much. 

Thank you, Mr. Chairman. I appreciate your indulgence. 

Mr. BURGESS. The gentleman yields back. The gentleman’s time 

has expired. 

The Chair recognizes the ranking member of the full committee, 

Mr. Pallone of New Jersey. Five minutes for questions. 

Mr. PALLONE. Thank you, Mr. Chairman. 

47 

Dr. Shuren, let me ask—and I think I said some of this before— 

but the Medical Device User Fee Amendments, or MDUFA, was 

first established in 2002. Prior to that, the medical device program 

was suffering from long-term loss of resources, lag in medical device review timetables, out-of-date guidance, and a lack of expertise 

among FDA personnel. And MDUFA has been a success in addressing these issues, reducing the average total time to a decision on 

a pre-market approval in 2015 by 35 percent over 6 years, and for 

a 510(k) in 2015 by 11 percent over 5 years. And I understand that 

in 2016 FDA approved 91 novel devices, the highest since the creation of MDUFA. 

As you know, the statute outlines a detailed process for reauthorization that requires FDA to not only negotiate with industry to develop recommendations, but also to solicit public input, hold public 

meetings, consult periodically with Congress and patient and consumer groups, among others. The recommendations that are the result of this process must also be available publicly for a period of 

public comment and, ultimately, are required by statute to be 

transmitted to Congress. 

So, can you discuss further the process FDA undertakes to prepare recommendations for reauthorization of the User Fee Agreements and, in particular, the timeline for these activities? 

Dr. SHUREN. We will quick establish a team, an interagency 

team. We have senior leadership for the agency that provides strategic direction and advice. We engage in discussions with the device industry. Usually, start-to-finish, when we first sit down to 

when a package comes to Congress is about 18 months. Along the 

way, we have a public meeting in the beginning; at the end, opportunity for public comment on the proposed package. And we also 

have monthly meetings with patient and consumer groups. So, a 

very interactive, thoughtful process. 

Mr. PALLONE. I thank you. 

So, you mentioned that if we do not reauthorize MDUFA by September 30th, CDRH would lose about one-third of its personnel. 

Can you discuss further the types of positions and personnel that 

would be subject to RIF notices? 

Dr. SHUREN. Physicians, nurses, engineers, a whole variety of 

scientists from, you know, biologists, physicists, chemists. It will 

run the gamut. 

Mr. PALLONE. OK. Now the User Fee Agreements between FDA 

and industry are the end result of many months of negotiations 

which are submitted to Congress after careful consideration of public comments and consultation with patients and consumers. And 

there are very real implications in terms of patient access to treatments and the personnel at FDA if Congress doesn’t authorize this 

program before it expires on September 30th. And I am committed 

to working with my colleagues across the aisle and across the Capitol to ensure that we meet this deadline. 

But I wanted to ask you, also, Dr. Shuren—and I know we are 

running out of time—FDA has increasingly focused on shifting data 

from the pre- to post-market setting for devices to facilitate innovation. However, central to this approach is an assurance that FDA 

and manufacturers will have the data they need to detect safety 

problems that are harming patients. FDA envisioned the creation 

48 

of the National Evaluation System for health Technologies, or 

NEST, to help collect the information using electronic health 

records, registries, and claims data. There is already considerable 

progress and momentum in adding unique device identifiers to 

EHRs, and there are now positive steps in adding unique device 

identifiers to health insurance claims data. 

So, speaking specifically to adding unique device identifiers in 

health insurance claims, what are the benefits unique to the incorporation of device identifiers to claims data from which FDA researchers and others can benefit? 

Dr. SHUREN. Well, one of the challenges with some of the other 

data sources like registries is they collect data on a patient for a 

short period of time. Claims data would allow us to have more 

long-term information on that patient, what is happening to them 

with the medical device. In some respects, linking up the claims 

data with other data sources, then, becomes a rich bod of evidence 

to use. 

Mr. PALLONE. OK. I actually didn’t run out of time. Thank you, 

Mr. Chairman. 

Thank you, Dr. Shuren. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. 

The Chair recognizes the gentleman from Florida, Mr. Bilirakis. 

Five minutes for questions, please. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. I appreciate it very 

much. 

Dr. Shuren, in the 21st Century Cures Act, we were able to pass 

reform language to modernize the Office of Combination Products. 

As you know, combination products are products on the market 

that have elements of a medical device and a drug, like inhalers 

or insulin injectors. Many patients need and rely on combination 

products. 

While we worked on the 21st Century Cures, I asked FDA about 

the innovation in the drug and device space, as more and more innovative products may be combination products. At the time, there 

were complaints from innovators about the slow and burdensome 

FDA process for approving combination products. At a hearing, you 

stated that this problem with combination products was a place 

that does require probably further discussion, and whether or not 

there are changes to be thought about it to make that intersection 

work better than it currently does. 

I was able to have language in the 21st Century Cures, again, 

to address some of these problems with combination products. Can 

you update us on what the FDA is doing on the device side to implement the Cures language for combination products and what 

was agreed to in the Medical Device User Fee Agreement? 

Dr. SHUREN. So, first off, let me say thank you for that provision, 

and I think it will be important, helpful in the work that we do 

on combination products, which we agree increasingly are becoming 

more and more important in our health care. 

So, we are working. The agency has an interagency group, first 

off, coordinated on implementation. We are a part of that group, 

and we will be engaged in the various pieces that have to be implemented for combination products. 

49 

We have also, prior to that, set up a Combination Product Policy 

Council that already started to make improvements in how we handle combination products. For starters, we have had a pilot underway that will be a full-fledged program very soon on streamlining 

consults between the involved centers, so that we are better working together, let’s say us and our Center for Drugs and our Center 

for the Biologics. So, again, getting the right expertise in a timely 

manner to facilitate those reviews of combination products. 

Mr. BILIRAKIS. Very good. Thank you. 

This question is a little bit outside the full scope of FDA. But 

what are the challenges that patients wrestle with for the coverage 

of FDA-approved medical devices? I have had conversations with 

doctors and patients who wanted to get an FDA-approved medical 

device, but CMS hasn’t approved that device for coverage. 

CMS lack of coverage for PET scans, for example, for Alzheimer’s 

diagnosis is, again, one example of backwards-thinking from Medicare. There are a number of FDA-approved medical devices that 

CMS has been slow to cover. 

I know that FDA was working with CMS on these types of payer 

issues with the Parallel Review Program. Can you update us on 

where things stand with your work with CMS and other payers? 

Do we see a reduction in devices getting covered? Do you have any 

metrics or data on how things have changed or improved? 

Dr. SHUREN. Well, this is an area we have devoted a lot of time 

and attention to because true patient access isn’t just a technology 

on the market. Particularly for our more expensive technologies, if 

there isn’t adequate reimbursement, then patients don’t have real 

access to it. 

That said, CMS and payers operate under a different standard 

that is appropriate for payers versus a regulator like us. So, we 

have been working with CMS and others, how do you streamline 

that pathway to market, and from market to coverage reimbursement? 

You mentioned Parallel Review, and that started as simply a 

process change, so that CMS could start engaging on a national 

coverage decision before we had approved the product. What we 

have now made available is, for interested companies, and on a voluntary basis, and if CMS and we agree, they can come and talk to 

us before they have done their big pivotal clinical trial, so that they 

can design their evidence generation to meet the needs, the standards for FDA and the standard for CMS. And we have had some 

interest, and one product, in particular, went through that and 

probably saved 2 years for their time to ultimately get reimbursement. 

We have been working with CMS also about can we better leverage real-world evidence. This case of transcatheter aortic heart 

valve replacement, when we first approved it, we worked with two 

healthcare professional societies on setting up a registry and with 

CMS. So, when we approved that device, Medicare covered it under 

a coverage with evidence development decision. And now, every 

time we approve a new indication, it is automatically covered by 

Medicare, which is different than many other countries. 

The other thing we have done is set up a similar opportunity 

with private payers. Again, if a company would like to do it and 

50 

the payer would like to do it, we are happy to have a meeting and 

share what our respective needs may be. 

Mr. BILIRAKIS. Very good. Thank you, Doctor. 

I yield back. Thank you, Mr. Chairman. 

Mr. BURGESS. The Chair thanks the gentleman. The gentleman 

yields back. 

The Chair recognizes the gentlelady from Illinois, Ms. Schakowsky. Five minutes for questions, please. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. 

I want to thank you, Dr. Shuren, for being with us today. 

Over the past few months, I have become increasingly concerned 

with the safety of two defibrillators manufactured by St. Jude Medical, which was recently acquired by Abbott. This issue first came 

to my attention when a staff member of mine was forced to undergo surgery to have her St. Jude defibrillator replaced because her 

device was no longer working properly. This is a young woman who 

has a congenital heart condition. 

Last October, FDA released a safety communication regarding 

battery depletion for two of St. Jude’s devices. At the time, two patients had died as a result of this faulty device and another 47 had 

reported dizziness or fainting. The rapid draining of a battery can 

happen in a matter of days, leaving patients with little time to rectify this issue before facing possibly grave consequences. 

Then, in January, FDA released another communication detailing a possible cybersecurity threat for these same devices manufactured by St. Jude’s Medical. Given the severity of these issues, I 

am very concerned for patients with these devices. 

In addition, I am appalled that patients are left to figure out how 

to pay for the required surgery to replace the device, despite finding themselves in that circumstance through no fault of their own. 

Finally, it is concerning that in some cases patients will learn 

about the problems with their device in the news before hearing 

about it from their doctor. 

So, Dr. Shuren, how are patients notified when there are problems with their device, and how does the FDA ensure that patients 

are given this information in a timely way? And if the safety communication is given to doctors, how do you ensure that doctors are 

communicating that information to patients? 

Dr. SHUREN. First of all, let me say that I am sorry to hear about 

what happened with your staffer. 

In terms of communications, while we can’t compel physicians to 

tell their patients, what we do is we put out information like with 

the safety communication, put it up on our Web site, but, then, we 

push it out to other organizations who push information or where 

healthcare professionals and patients get their information. Also, 

one of the reasons you will see it in newspapers is because patients 

get their information from the news. So, we push it out to those 

news services as a way of getting into patients, since, otherwise, it 

is hard for us to reach into people’s homes to get it there. 

And then, we try to provide the best information possible for both 

patients and healthcare professionals to make the best informed 

decisions that is right for their particular care. 

51 

Ms. SCHAKOWSKY. Let me ask you—I have a few more questions—how is the FDA notified of these problems in the first place? 

Do you rely on the device manufacturer to report any issues? 

Dr. SHUREN. So, sometimes we hear from the device manufacturer. We get adverse event reports. We get complaints. We can go 

in the door, conduct an inspection. We may identify problems. 

There is a lot of tools that we have. 

Ms. SCHAKOWSKY. Are they required, though, however, the manufacturers, are they required, if they discover a problem, to report 

it? 

Dr. SHUREN. If they discover a problem of that kind of a serious 

nature, then, yes, they would be contacted. 

Ms. SCHAKOWSKY. And did St. Jude’s? 

Dr. SHUREN. We did have conversations with St. Jude and we 

have been working with St. Jude on the steps to take to address 

those two particular issues. 

Ms. SCHAKOWSKY. How does the FDA plan to improve their postmarket surveillance system, to improve notification of problems 

with medical devices, and to better track cases of patients who 

have been impacted by faulty devices? 

Dr. SHUREN. Yes. So, first off, in terms of better communication 

out, there are certain tools—there is a limitation of the tools that 

we may have, but our healthcare system may start driving that 

more and more. I have seen increasingly patients having access, if 

you will, to their own record and healthcare professionals communicating directly to them. Even my wife just had that instant messaging between her and her treating physician. 

In terms of how we have a better sense of patients who are affected, NEST is one of those areas that can help how we are better 

able to leverage data that is out there that is being collected on patients. Including a unique device identifier in like electronic health 

records will make it easier for us to link the specific device that 

is being used that may be subject to a recall, let’s say, with the patients who get them. 

But, that said, it is absolutely critical—— 

Ms. SCHAKOWSKY. Let me ask about a recall. So, if a device manufacturer continues to manufacture defective devices or has an ongoing recall or safety notification, what tools or authority does FDA 

have available to ensure patient safety? 

Dr. SHUREN. So, we have a variety of enforcement tools. The first 

thing we will do with the company is will they work with us to resolve the problem. So, in a recall, most of them are voluntary because, if we contact the company and they work with us, we can 

address that problem much more quickly than if we went with an 

FDA-mandated recall, which is going to take a lot more time. 

If a company is not working with us, then we may move to a variety of steps. There may be a warning letter if products shouldn’t 

be on the market. We may have an injunction. We may have a seizure. If there are issues more broadly with the company, we may 

put them under a consent decree. 

Ms. SCHAKOWSKY. Thank you. I yield back. 

Mr. BURGESS. The Chair thanks the gentlelady. The gentlelady 

yields back. 

52 

The Chair recognizes the gentleman from Missouri, Mr. Long, for 

5 minutes for your questions, please. 

Mr. LONG. Thank you, Mr. Chairman. 

And, Dr. Shuren, there are a number of commitments in this 

agreement that complement provisions in the 21st Century Cures. 

Can you highlight a few of these provisions and speak to whether 

FDA would be able to implement them if Congress did not reauthorize this User Fee Agreement by September? 

Dr. SHUREN. So, there are several provisions in there on patient 

engagement in MDUFA IV and real-world evidence. While the complementary provisions in 21st Century Cures do not apply to devices—they are focused on drugs—we consider them important and 

they dovetail with what Congress would like to see more generally. 

I think as well the provisions on clinical trials and their moving 

from local IRB to a central IRB is going to help speed the conduct 

of clinical trials that are going to support coming through market 

and review under the User Fee Program. I think some of the clarity around valid scientific evidence also is related to the work that 

we do under the User Fee Program. The same for combination 

products because those two are subject to the User Fee Program. 

So, I see lots of synergy between 21st Century Cures and MDUFA 

IV. 

In terms of what happens if we are not able to reauthorize 

MDUFA IV, then we are going to lose a third of our staff immediately. We will see more that leave afterwards, and we will not 

be able to make good on not only our current MDUFA commitments, which would all sunset, but just running the program to do 

anything is going to be challenging. 

Mr. LONG. Several consumer groups have raised concerns that 

the use of real-world evidence could ultimately result in FDA approving products based on insufficient clinical data. Can you please 

address those concerns? 

Dr. SHUREN. No, I don’t think either MDUFA IV or anything else 

that has come on the table is going to adversely impact the data 

that we are able to rely on to make informed decisions. So, for example, real-world evidence, part of this is looking at the pilots not 

only for setting up the program and looking at return on investment, but nothing says that we have to accept a particular data 

source. 

Mr. LONG. OK. 

Dr. SHUREN. That evidence still has to be relevant to the question. It has got to be sufficiently reliable for us to make a decision. 

So, this doesn’t change any of the standards on which we make decisions. It doesn’t change what we will expect to have adequate evidence to make a decision. 

Mr. LONG. OK. Thank you for being here and thank you for your 

testimony today. 

Mr. Chairman, I yield back. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. 

Just a note. We will be going immediately to the second panel 

after the conclusion of Dr. Shuren’s questions. 

Now I would like to recognize the gentleman from New Jersey. 

Five minutes for questions, please. 

53 

Mr. LANCE. Thank you very much, Mr. Chairman. 

Good morning to you, Dr. Shuren. 

I understand that in the most recent MDUFA Quarterly Report 

FDA’s total time metrics to review pre-market approval devices is 

rising. This is not the direction any of us wish to see things go. Do 

you know what is behind the increase and what sort of tools are 

included in the new MDUFA agreement that might help prevent 

these sorts of total time increases in the future? 

Dr. SHUREN. Yes, we have seen a small uptick, but we are in the 

process of looking into it. We are looking into a variety of factors. 

One I had mentioned is the increased workload we saw in MDUFA 

III, particularly, for example, submissions from some of the most 

innovative technologies. 

So, on the one hand, we are seeing more innovative technology 

come to the U.S. That is a good sign. It also means the workload 

goes up with it, and that might be one of the contributors. But we 

will have a better sense in the coming weeks. 

I think MDUFA IV is going to help in terms of providing more 

resources for the people that we need for doing the work, to enhance some of our IT systems, to establish a quality management 

system which also can drive greater efficiencies, and other steps 

that I think will drive greater consistency as well in our work. And 

all of that will help us have a better-running program. 

Mr. LANCE. Thank you very much, Doctor. 

I have heard from many device companies that the pre-submission process has been a positive addition. It was established in the 

previous MDUFA agreement, and that it helps improve consistency 

and predictability in the device review process. 

Doctor, would you please explain what the pre-submission process is and how the next MDUFA agreement will improve upon it? 

Dr. SHUREN. So, pre-submission process is an opportunity for a 

company to request to meet with the agency to have specific questions answered. You know, traditionally, a lot of times this is 

around what evidence do they need to bring a product to market. 

What MDUFA IV will do is it puts in performance goals for the 

timing of those meetings. It would have us commit to provide answers to the questions that are being asked at least five days before the meeting. And then, a company may be, ‘‘You know what? 

We don’t even need to meet.’’ Or we can meet, but we will have a 

better-informed discussion because we already got feedback from 

the Center. 

Mr. LANCE. Thank you very much, Dr. Shuren. 

And, Mr. Chairman, I yield back 2 minutes, 34 seconds. 

Mr. BURGESS. The Chair thanks the gentleman for his generosity. The gentleman yields back. 

Dr. Shuren, this was not a plant, I guess, but on Gene Green’s 

desk was a printout of the Houston Chronicle from I guess this 

morning, today’s Houston Chronicle. And you were asked the question about what is on the horizon, and you mentioned robotics; you 

mentioned minimally invasive surgery. So, you are on the front 

page of the Houston Chronicle, where, after all, heart surgery was 

invented, right, Mr. Green? Well, maybe not, but maybe a little bit 

of poetic license. I went to medical school in Houston, so I have got 

a lot of affection for the city. 

54 

But there is an article on the front page about doing just what 

you talked about, replacing an aortic valve through a tiny, little incision in the chest, and sparing that patient what used to be a 

much more major operation just to expose the operative field in 

order to replace the valve. So, it is really a game-changer, really 

groundbreaking, and we have been part of it this morning, for 

which we are all extremely fortunate. 

Mr. GREEN. Mr. Chairman, since you mentioned that, you know, 

Dr. DeBakey and Dr. Cooley, who have since passed away, but they 

set—for heart surgery, it is just amazing in the Texas Medical Center, one at Baylor College of Medicine, another one at University 

of Texas, the Health Science Center there. 

So, thank you. Thank you for that plug. 

Mr. BURGESS. Again, Dr. Shuren, seeing no other Members wishing to ask questions, we are going to conclude this portion of the 

hearing. As we transition to our second panel of witnesses, Dr. 

Shuren, especially we want to thank you for spending so much 

time with us this morning, for being willing to come back to our 

committee, our subcommittee, and give us the current update on 

the Medical Device User Fee Agreements. 

Again, I would just stress that we all look forward to having that 

accomplished, and I realize there may be people who talk about improvements along the way. We welcome that discussion. But, make 

no mistake about it, we are going to get our work done, and we will 

have it done in a timely fashion. 

So, thank you much, Dr. Shuren, for your time this morning. 

And we will go immediately to our second panel who I will introduce in just a moment. 

Dr. Shuren, you are excused. Thank you. 

And again, as we transition to our second panel, I want to thank 

our second panel of witnesses for being here with us today and taking time to testify to the subcommittee on this important topic. 

As a reminder, each witness will have the opportunity to give an 

opening statement, followed by questions from Members. 

Our second panel of witnesses today include Ms. Cynthia Bens, 

vice president of public policy for the Alliance for Aging Research; 

Mr. Robert Kieval, founder and chief development officer at CVRx; 

Mr. Patrick Daly, president and CEO of Cohera Medical, and Ms. 

Diane Wurzburger, executive, Regulatory Affairs, U.S.-Canada 

Global Strategy, Policy, and Programs at GE Healthcare. 

We appreciate all of you being here with us today. We thank you 

for your forbearance during the first panel. 

And we will begin this panel with you, Ms. Bens, and you are 

recognized for 5 minutes for an opening statement, please. 

55 

STATEMENTS OF CYNTHIA A. BENS, VICE PRESIDENT OF PUBLIC POLICY, ALLIANCE FOR AGING RESEARCH; ROBERT 

KIEVAL, FOUNDER AND CHIEF DEVELOPMENT OFFICER, 

CVRx, PATRICK DALY, PRESIDENT AND CHIEF EXECUTIVE 

OFFICER, COHERA MEDICAL; AND DIANE WURZBURGER, EXECUTIVE OF REGULATORY AFFAIRS, GE HEALTHCARE, ON 

BEHALF OF THE MEDICAL IMAGING & TECHNOLOGY ALLIANCE 

STATEMENT OF CYNTHIA A. BENS 

Ms. BENS. Mr. Chairman, Ranking Member Green, and members 

of the subcommittee, it is an honor to speak to you today about the 

reauthorization of the Medical Device User Fee Program on behalf 

of the Alliance for Aging Research. 

The Alliance is the leading nonprofit organization dedicated to 

accelerating the pace of scientific discoveries and their application 

to improve the experience of aging and health. 

Right now, approximately 10 percent of the U.S. population is 

age 80 or older. This 80-plus age group will triple by 2050. Many 

older adults are fortunate to experience better health as they age 

than the previous generation. But the truth is that most older 

adults still face significant periods of disability and illness later on 

life. 

The develop one or more forms of cardiovascular disease, cancer, 

diabetes, bone and joint degeneration, muscle wasting, vision and 

hearing loss, neurological diseases, and incontinence. In our view, 

the need for innovative medical devices that help diagnose and better respond to the physical declines people face as they age have 

never been greater. 

And we believe we will only realize the benefits of these medical 

technologies if the FDA has access to the resources and expertise 

necessary to evaluate them, the medical device industry is certain 

that their products are going to be assessed in a timely manner, 

and, most importantly, that patients are at the center of new product development. 

Thanks to you and your colleagues in Congress, the Alliance and 

other groups were represented throughout the patient/consumer/ 

stakeholder consultation phase leading up to the third reauthorization of MDUFA. We had two goals for MDUFA III, and we are 

pleased to report that both were achieved. 

The first was to make sure that CDRH had sufficient resources 

to conduct timely reviews, and the second was to secure support for 

a process through which CDRH would include patient fees on the 

benefits and risks of devices during their product reviews. 

MDUFA III allowed for the application of user fees to higher additional reviewers, reduce the ratio of reviewers to managers, and 

continue the FDA’s third-party review program. 

CDRH engaged with the patient advocacy community to best 

characterize disease severity and unmet need. And this led to the 

benefit/risk guidance that we heard a lot about this morning that 

broadly defines the benefits CDRH is interested in understanding 

and started the process for incorporating these views into product 

reviews. 

56 

Recognizing that there were many process improvements instituted through MDUFA III, we sought further support for CDRH’s 

workforce, expansion of the patient-centered device development, 

and the utilization of real-world evidence in MDUFA IV. 

MDUFA IV contains critical commitments and funding for the 

FDA that will benefit patients. We are pleased that the reauthorization of the User Fee Agreements is a priority for this committee. 

MDUFA IV will lead to significant reductions in the time it takes 

the FDA to review the most common types of medical device applications, and that is not only going to benefit industry; it is going 

to accelerate patient access. 

Having expert FDA staff to carry out user-fee-funded activities is 

paramount, and the MDUFA IV agreement permits CDRH to apply 

user fees to increase the retention of high-performing supervisors, 

reduce the ratio of review staff to supervisors, and hire new medical device application reviewers, as well as to recruit additional 

HR support services, which is something that we were all encouraged by in 21st Century Cures. 

The MDUFA IV agreement seeks to bolster and ensure the integrity of the third-party review program, and we are glad that CDRH 

continues to have the resources and flexibility to employ outside experts as needed under MDUFA IV. 

CDRH will further advance patient involvement in the regulatory process. They will expand staff capacity to respond to device 

submissions containing validated patient preference information 

and patient-reported outcomes. 

CDRH will hold public meetings to discuss approaches for incorporating this type of information into device submissions, as well 

as other methods for advancing patient engagement. 

CDRH will explore ways to use patient input to inform clinical 

study design and reduce barriers to patient participation in clinical 

trials. 

MDUFA IV will elevate CDRH’s ability to further real-world evidence generation for the purposes of informing regulatory activities. 

The collection of data generated through routine clinical care can 

help broaden our understanding of how products are working, support the incremental process of medical product development, and 

optimize care. 

CDRH can utilize MDUFA IV fees to hire staff with expertise in 

the utilization of real-world evidence and further establish the Coordinating Center for the National Evaluation System for health 

Technology. NEST will link health claims, electronic records, and 

registry data. 

MDUFA IV funds, the NEST Coordinating Committee, they are 

going to be able to establish a patient-incorporated pilot program 

to explore the usability of real-world evidence for determining expanded access as well as new device approvals, and better understand how devices are malfunctioning. 

The NEST public program is particularly meaningful for our organization since older adults are not adequately represented in 

clinical studies. The MDUFA IV agreement actually specifies that 

industry will have 25-percent representation on the NEST Governing Board, and we hope that the enacting legislation will furVerDate Mar 15 2010 10:41 Oct 19, 2018 Jkt 037690 PO 00000 Frm 00060 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X20USERFEES\115X20USERFEESWORKING WAYNE
57 

ther specify the remaining 75 percent of the Governing Board composition and give particular attention to patient populations most 

likely to be affected by increased utilization of real-world evidence. 

The MDUFA IV agreements will increase efficiency of the regulatory process, reduce the time it takes to bring safe and effective 

medical devices to market, and put patients at the heart of medical 

product developments. 

So, I am going to close by offering our support for the continuation of the MDUFA program. 

Thank you for the opportunity to present our views today. 

[The prepared statement of Ms. Bens follows:] 

58 


25747.016

Testimony of Cynthia A. Bens, Vice President of Public Policy 

Alliance for Aging Research 

United States House of Representatives 

Energy and Commerce Committee, Subcommittee on Health 

Hearing on "Examining FDA's Medical Device User Fee Program" 

March 28, 2017 

Mr. Chairman, Ranking Member Green, and Members of the Subcommittee: 

It is an honor and a privilege to speak with you today about the reauthorization of the Medical 

Device User Fee Act (MDUFA) program, on behalf of the Alliance for Aging Research. 

I am Cynthia Bens, the Vice President of Public Policy at the Alliance. The Alliance for Aging 

Research is the leading non-profit organization dedicated to accelerating the pace of scientific 

discoveries and their application to improve the experience of aging and health. We believe 

that advances in research help people live longer, happier, more productive lives and reduce 

health care costs over the long term. 

Most of us are keenly aware that our population is aging at an unprecedented rate. Ten 

thousand Baby Boomers are turning 65 each day. This is up from 6,000 per day just 6 years ago. 

People age 85 and older are the fastest growing segments of our population. Right now, 

approximately 10 percent of the U.S. population is age 80 or older. This 80+ age group will 

reach 30 percent of the U.S. population by 2050. 

Many older adults today are fortunate to experience better health as they age than previous 

generations. But the truth is that most older adults still face significant periods of illness and 

disability later in life, often from multiple chronic conditions that require complex care 

1 
59 


25747.017

management. They develop one or more forms of cardiovascular disease, cancer, diabetes, 

bone and joint degeneration, muscle wasting, vision and hearing loss, neurological diseases, 

and incontinence. 

In our view, the need for innovative medical devices that help diagnose and respond to the 

physical declines people face as they age has never been greater. We believe that we will only 

realize the benefits of these medical technologies if the U.S. Food and Drug Administration 

(FDA) has access to the resources and expertise necessary to evaluate them, the medical device 

industry is certain that their products will be assessed in a timely manner, and patients are at 

the center of new product development. 

For more than a decade, the Alliance for Aging Research has been working directly with the 

FDA, other patient advocates, researchers, and industry on ways to streamline the regulatory 

process for the benefit of older adults. We understand that user fees play an essential role in 

maintaining FDA review processes that efficiently deliver safe and effective medical devices to 

patients who need them, and that is why we engage in the MDUFA reauthorization process. 

Historical Perspective on the MDUFA Program 

Prior to the third reauthorization of MDUFA, patient and consumer organizations were not able 

to engage in the negotiations between the FDA and industry. Thanks to you and your colleagues 

in Congress, the Alliance for Aging Research and other groups were represented throughout the 

patient/consumer stakeholder consultation phase leading up to third reauthorization of 

MDUFA. We had an opportunity to provide feedback to the FDA as negotiations were taking 

place and propose enhancements to be included in the final commitment letter that emerged 

from the negotiations. 

Going into monthly consultation meetings with the FDA, we had two goals for MDUFA Ill. The 

first was to make sure that the Center for Devices and Radiological Health (CDRH) had sufficient 

2 
60 


25747.018

resources under MDUFA Ill to carry out timely reviews. The second was to secure support for a 

process through which CDRH would include patient views on the benefits and risks of devices 

during product reviews. After several monthly meetings with the agency, industry's desire for a 

more predictable and collaborative review process came into focus and the FDA expressed a 

desire to address personnel issues within CDRH. These challenges seemed to be impeding 

device review and delaying patient access. 

MDUFA Ill allowed the application of user fees to help cultivate existing CDRH staff and to 

recruit and retain new talent. To strengthen the FDA's device review capacity, fees were aimed 

at hiring additional reviewers and reducing the ratio of reviewers to managers. MDUFA Ill also 

continued the FDA's third-party review program. This program is intended to reduce the 

review burden for lower-risk devices, by allowing FDA to leverage external experts. 

To address the need for more predictability and collaboration in the review process for devices, 

MDUFA Ill included provisions aimed at improving formal and informal communication 

between the FDA and device makers. FDA took an important step by developing a formalized 

approach to address specific questions from industry prior to their submission of applications 

for products. FDA also implemented revised submission acceptance criteria, including an 

updated "refuse to accept" checklist, by which FDA would evaluate submissions to ensure that 

agency resources were focused on reviewing complete applications. 

FDA's creation of a process for incorporating patient views on the benefits and risks of medical 

devices was an Alliance priority under MDUFA Ill. CDRH was a leader among regulators in 

aggressively pursuing a transparent and structured benefit-risk framework. Finalizing a benefitrisk guidance for devices was one of CDRH's first actions in MDUFA Ill implementation. The 

benefit-risk guidance, first issued by FDA in 2015, broadly defines the benefits they are 

interested in understanding. The type of benefit CDRH specifically calls out are not just a 

device's impact on clinical management of a disease and patient health, but also patient 

satisfaction, improvement in quality of life, improvement in function, reduction in lost function, 

3 
61 


25747.019

reduction in probable mortality, and symptom relief. For diagnostics, benefit could be assessed 

according to the public health impact, the ability to identify a specific disease and potentially 

prevent its spread, predicting future disease onset, providing earlier diagnosis of diseases, or 

identifying patients more likely to respond to a given therapy. 

The benefit-risk guidance also laid out the ways in which CDRH assesses the magnitude of 

benefit, the probability of a patient experiencing benefit, and the duration of benefit. The 

guidance provides details, some examples, and a copy of the worksheet that reviewers use in 

their benefit-risk determinations. 

Benefit-risk calculation is discussed frequently but there is the potential for this type of exercise 

to be more tokenism than substance. We feel that CDRH got the substance of the patient 

experience right and we think that is because they actively engaged with the patient advocacy 

community to best characterize disease severity and unmet need from the start. 

Recognizing that many review process improvements were instituted through MDUFA Ill, the 

Alliance for Aging Research sought further support for CDRH's workforce, expansion of patientcentered medical device development, and the utilization of real-world evidence by CDRH in 

MDUFA IV. 

MDUFA IV Agreement Benefits to Patients 

The Alliance for Aging Research was fortunate to offer patient perspectives to the FDA through 

monthly stakeholder consultations and public meetings held over the last year as the agency 

negotiated the MDUFA IV agreement. We strongly support the continuation of this user fee 

program. MDUFA IV contains critical commitments and funding for the FDA that will benefit 

patients. We are pleased that the reauthorization of the user fee agreements is a priority for 

this Committee. We would like to call your attention to the following sections of the agreement 

that we offered comment, during the stakeholder meetings. 

4 
62 


25747.020

1.) Supporting CDRH Workforce 

MDUFA IV will lead to significant reductions in the time it takes the FDA to review the most 

common types of medical device applications. This will not only benefit industry, but also 

accelerate patient access. Under MDUFA IV, the FDA has committed to reduce the days for 

review of 510 (k) applications and for premarket approval (PMA) applications. FDA also set 

goals for reviewing De Novo applications. The number of De Novo requests has increased 

steadily since the pathway was created. The limited resources currently available to the agency 

for de novo requests have resulted in missed target dates for review in all but 40 percent of 

cases. Section II. E of the MDUFA IV agreement specifies that the agency set a goal of reviewing 

70 percent of de novo requests on time by FY 2020. 

Having expert FDA staff to carry out user-fee-funded activities is paramount. Without the 

necessary number and types of staff, the FDA will not be able to meet the ambitious 

performance goals for which the MDUFA IV resources are intended. Problems with FDA 

recruitment and hiring have existed for years because the agency lacked hiring processes and 

pay scales that were competitive with the private sector. The 2151 Century Cures Act included 

some positive provisions to help FDA attract and hire new senior staff, but MDUFA IV provides 

CDRH with needed funding to hire across medical device review activities and cultivate existing 

staff. Specifically, Section Ill, B. of the MDUFA IV agreement, permits CDRH to apply user fees 

for the improvement of its scientific and regulatory review capacity. With these fees, CDRH 

intends to increase the retention rate of high-performing supervisors, reduce the ratio of 

review staff to supervisors, hire new device application reviewers, and utilize recruitment 

support to augment existing human resource services. 

The Alliance for Aging Research is supportive of Section IV. E of the MDUFA IV agreement that 

seeks to bolster the third-party review program within CDRH. We advocated for the use of 

MDUFA Ill fees for the third-party review program so that CDRH's staff would have more time 

5 
63 


25747.021

to devote to higher-risk device applications. It is our understanding that third-party review 

continues to be valuable for lower-risk devices, but the program requires improvements to 

make it more efficient. We are glad that CDRH continues to have the resources and flexibility 

to employ outside experts as needed under MDUFA IV and that there will be improvements 

made to the third-party review program to ensure its integrity. 

II.) Expanding Patient-Centered Medical Device Development 

The Alliance for Aging Research applauds the FDA for fostering the use of patient preference 

information in the review and approval of medical devices. Of late, industry has begun including 

patient-centered endpoints in development programs, signaling a growing interest by industry 

to employ patient-reported outcomes in device trials with more regularity. FDA has responded 

by drawing patient representatives earlier into the device review process, developing a 

systematic benefit-risk framework for the evaluation of new devices, and creating a Patient 

Engagement Advisory Committee. 

Section IV. F of the MDUFA IV agreement details activities that CDRH will take to further 

advance patient input and involvement in the regulatory process. CDRH will develop scientific 

expertise and expand staff capacity to respond to device submissions containing publicly 

available and validated, patient preference information or patient reported outcomes. This 

section also calls for public meetings to discuss approaches for incorporating patient preference 

information and patient reported outcomes as evidence in device submissions, as well as other 

methods of advancing patient engagement. CDRH will also explore ways to use patient input to 

inform clinical study design and reduce barriers to patient participation by facilitating 

recruitment and retention. The MDUFA IV agreement calls on the FDA to identify priority areas 

in which patient preference information could inform regulatory decision making and requires 

publication of these priorities in the Federal Register. 

6 
64 


25747.022

Ill.) Utilizing Real-World Evidence 

The Alliance sought the application of MDUFA IV resources to elevate CDRH's ability to further 

real-world evidence generation for the purposes of informing regulatory activities. We believe 

that the collection of data generated through routine clinical care can help broaden our 

understanding of how products are working in the real world, support the incremental process 

of medical device development, and lead to optimal care. 

Under Section IV. H of the MDUFA IV agreement, CDRH can utilize user fees to hire staff with 

expertise in the use of real-world evidence and establish a Coordinating Center for the National 

Evaluation System for health Technology (NEST). NEST will link health claims, electronic records, 

and registry data. In the future, these activities have the potential to decrease the number of 

stand-alone clinical trials, increase enrollment efficiencies, and make patient follow up less 

burdensome. 

With MDUFA IV funds, the NEST Coordinating Committee will undertake a pilot program to 

explore the usability of real-world evidence for determining expanded indications for device 

use, new device approval, and device malfunction reporting. The NEST pilot program is 

particularly meaningful for our organization since older adults are not adequately represented 

in most clinical studies. 

The Alliance for Aging Research requests one change to the MDUFA IV agreement. Section IV. 

H. states that "Industry representation on the NEST governing board will make up at least 2S 

percent of the governing board membership." MDUFA IV generally references anticipated 

representation of the patient community on the NEST governing board. We believe that the 

enacting legislation should detail the composition of the remaining 7S percent of the governing 

board and include representatives of patient populations most likely to be affected by 

increased utilization of real-world evidence (e.g. the elderly, those with multiple chronic 

conditions, women, etc.). If patient preference is truly a priority for the FDA and industry, 

7 
65 


25747.023

representation by patient representatives on the NEST governing board should be more clearly 

outlined. 

Conclusion 

As mentioned previously, the Alliance for Aging Research supports the continuation of the 

medical device user fee program through the negotiated MDUFA IV agreement. The Alliance 

advocates for increased overall funding of the FDA with strong emphasis on finding the right 

balance between user fees and appropriated funding. We think that the size of the proposed 

fees within the MDUFA IV agreement is necessary to increase the efficiency of regulatory 

processes, reduce the time it takes to bring safe and effective medical devices market, and put 

patients at the heart of medical product development. 

Despite the opportunities afforded by MDUFA IV, we are all in jeopardy if the FDA's budget 

authority remains flat or is significantly reduced in the coming fiscal year. As you are aware, 

not all FDA activities can be supported through user fees. Crucial safety and surveillance 

activities as well as oversight of over-the-counter medications and other products, fall outside 

of the user fee programs. While FDA appropriations are not under the jurisdiction of this 

Committee, it is our hope that you will join us in calling for sufficient budget authority to 

maintain the overall health of this essential agency. 

Thank you for the opportunity to present our views today. The Alliance for Aging Research looks 

forward to working with you on enacting legislation to reauthorize this important program. I am 

happy to answer any questions you may have. 

8 
66 

Mr. BURGESS. And we thank you for your testimony. 

Mr. Kieval, you are recognized for 5 minutes. Summarize your 

opening statement, please. 

STATEMENT OF ROBERT KIEVAL 

Mr. KIEVAL. Thank you, Mr. Chairman Burgess, Ranking Member Green, and members of the subcommittee, for this opportunity 

to testify today. 

My name is Robert Kieval, and I am the founder of CVRx, a 

small company that provides implantable medical technologies to 

treat patients suffering from heart failure and problematic high 

blood pressure. These are among the most prevalent debilitating 

and expensive diseases for our healthcare system to manage, and 

our therapy which is available today in Europe—and, hopefully, 

will be soon here in the U.S.—stands both to improve patients’ 

lives and significantly reduce the staggering costs associated with 

their care. 

I have also been asked to testify here today on behalf of the Medical Device Manufacturers Association, founded in 1992 to be a 

voice of the innovative and entrepreneurial sector of our industry. 

CVRx is also a proud member of AdvaMed, whom my colleague Mr. 

Daly is testifying for today. 

Ninety-eight percent of medtech companies have fewer than 500 

employees, while more than 80 percent have less than 50. Yet, we 

are the major source of innovation and America’s competitive advantage in medical technology. Together, we comprise a diverse 

group of engineers, physicians, and entrepreneurs who dedicate our 

lives to alleviating human suffering and improving patient care. 

My personal journey with CVRx is now in its 16th year. As a 

small company with one product and no other revenue streams, 

CVRx, like many others in our position, is dependent on outside investment to be able to continue our work. To garner financing, our 

investors need assurance that the regulatory process be reasonable 

and consistent. Our capital is limited and precious, and regulatory 

delays can have devastating consequences for our company and for 

the patients who we are working to serve. 

Over the past 5 years under MDUFA III, the FDA Safety and Innovation Act, and FDA’s commitment to those reforms, the regulatory process has become more reasonable, consistent, and transparent. With the additional resources provided in MDUFA IV and, 

if implemented correctly, we believe that this proposed agreement 

can help further improve access for American citizens to safe and 

effective new medical technologies. 

While speed is always important when lives hang in the balance, 

our membership overwhelmingly endorsed prioritizing quality, predictability, and transparency in our negotiations. MDUFA IV includes important updates and new elements to strengthen and balance the regulatory environment. Here are a few highlights: 

There are new provisions to include consideration of patient’s 

perspectives in the design of clinical trials, which will help tie product evaluation to outcomes that are important to patients. 

A pilot to establish the value of real-world evidence and linkages 

among data sources to enable greater use of this information, to accelerate patient access in a pre-market setting. 

67 

To help keep the review process focused, reviewers would now be 

asked to cite the specific justification and applicable regulation for 

any deficiency letter or data requests that they issue. This will ensure that queries are meaningful and that time spent by both parties to resolve them is productive. 

A new quality management program will help FDA remain efficient as it continues to grow and evolve. The quality team will 

monitor and report on performance across the various branches of 

the agency and help ensure that deficiencies and inefficiencies are 

identified and addressed. This will provide more transparency 

within the FDA and help ensure that our new heart failure therapy 

receives the same quality of review in the Cardiovascular Division 

that a new incontinence treatment would in the Urology Division. 

Finally, the agreement establishes new performance goals aimed 

at placing new technologies into the hands of patients and providers within a reasonable period of time. These include updated 

decision time targets for 510(k)s and PMAs and now also review 

time goals for de novo technologies and pre-submissions. 

We believe that MDUFA IV can strengthen and provide increased confidence in the regulatory process. We also acknowledge 

that it is incumbent upon our industry to ensure that our work and 

our submissions are also of the highest quality. 

We thank FDA for these productive negotiations, and we look 

forward to continuing to work with them and with you to maintain 

a regulatory environment that rewards innovation while ensuring 

patient care. 

Surely our healthcare system will continue to face pressing challenges in the 21st century. Patients and providers will continue to 

seek therapies that alleviate suffering and save lives. My colleagues and I remain committed to finding the solutions they need 

and to working with our fellow stakeholders in the healthcare ecosystem to deliver these as quickly and efficiently as possible. 

Thank you very much. 

[The prepared statement of Mr. Kieval follows:] 

68 


25747.024

Testimony of Robert Kieval 

Founder and Chief Development Officer, CVRx 

Board Member, Medical Device Manufacturers Association (MDMA) 

"Examining FDA's Medical Device User Fee Program" Hearing 

March 28,2017 

House Energy and Commerce Committee, Subcommittee on Health 

1 
69 


25747.025

Thank you Chairman Burgess, Ranking Member Green and Members of the 

subcommittee for this opportunity to testifY today. My name is Robert Kieval and 

I'm the Founder of CVRx, a small company that provides implantable medical 

technologies to treat patients suffering from heart failure or problematic high blood 

pressure. These are among the most prevalent, debilitating and expensive diseases 

for our health care system to manage, and our therapy, which is available today in 

Europe and hopefully will be soon in the U.S., stands to both improve patients' 

lives and significantly reduce the staggering costs associated with their care. 

I'm also here today on behalf of the Medical Device Manufacturers Association, 

which was founded in 1992 to be the voice of the innovative and entrepreneurial 

sector of our industry. 98% of med tech companies have fewer than 500 

employees, while more than 80% have less than 50, yet we are the major source of 

innovation and America's competitive advantage in medical technology. Together, 

we comprise a diverse group of engineers, physicians and entrepreneurs who 

dedicate our lives to alleviating human suffering and improving patient care. My 

personal journey with CVRx is now in its 16th year. 
70 


25747.026

As a small company with one product and no other revenue streams, CVRx, like 

many others in our position, remain dependent on outside investment to be able to 

continue our work. To gamer financing, our investors need assurance that the 

regulatory process be reasonable and consistent. Our capital is limited and 

precious, and regulatory delays can have devastating consequences for our company 

and for the patients whom we're working to serve. 

When colleagues of mine testified before this committee five years ago, our 

industry faced a crisis. A grandmother with heart failure in Sweden or an injured 

construction worker in Sicily could be treated with American medical technology 

years before they could have been here in the U.S. The regulatory pathways had 

become unreasonable, unpredictable and opaque, and the harsh reality was that 

American patients who desperately needed our innovations couldn't get access to 

them. 

Over the past five years, under MDUF A III and other reforms including the FDA 

Safety and Innovation Act (FDASIA), the process has become more reasonable, 
71 


25747.027

consistent and transparent. Implemented correctly, we believe that the proposed 

MDUF A IV agreement will further improve access for American citizens to safe 

and effective new medical technologies. 

While speed is always important when lives hang in the balance, the MDMA 

membership overwhelmingly endorsed prioritizing quality, predictability and 

transparency in our negotiations. MDUF A IV contains ongoing provisions that 

include shared performance goals and process improvements, and important new 

elements including the establishment of a quality management infrastructure at 

FDA, consideration of patient perspectives in the design of clinical trials, and steps 

toward incorporation of real world evidence in the approval process. Here are just a 

few highlights: 

As innovators, it's frustrating to us when we receive requests for data or deficiency 

letters that are unreasonable, without reason or aren't germane to the evaluation of a 

product's safety or efficacy. These result in needless delays and wasted resources 

for both us and the FDA. Under MDUFA IV, reviewers would now need to cite the 

4 
72 


25747.028

specific justification and applicable regulation for any deficiency letter or data 

request. This will ensure that queries are meaningful and that time spent by both 

parties is productive. 

As FDA continues to grow and evolve, it's critical that it remains efficient, and 

MDUF A IV institutes a quality management program for this purpose. The team 

will report on the performance across the various branches of the agency, and help 

ensure that deficiencies and inefficiencies are identified and addressed. This will 

provide more transparency within the FDA, and help ensure that our new heart 

failure therapy receives the same quality of review in the cardiovascular division 

that a new incontinence treatment would in the urology division. 

Finally, the agreement establishes new performance goals aimed at placing new 

technologies into the hands of patients and providers within a reasonable period of 

time. These include updated decision time targets for 51 O(k)s and PMAs, and now 

also review time goals for De Novo technologies and pre-submissions. 

5 
73 


25747.029

We believe that MDUFA IV can strengthen and provide increased confidence in the 

regulatory process. We also acknowledge it's incumbent upon industry to ensure 

that our work and our submissions are also of the highest quality. We thank FDA 

for these productive negotiations, and we look forward to continuing to work with 

them and with you to maintain a regulatory environment that rewards innovation 

while ensuring patient safety. 

Surely, our health care system will continue to face pressing challenges in the 21st 

century. Patients and providers will continue to seek therapies that alleviate 

suffering and save lives. My colleagues and I remain committed to finding the 

solutions they need, and to working with our fellow stakeholders in health care to 

deliver these as quickly and efficiently as possible. Thank you. 

6 
74 

Mr. BURGESS. The Chair thanks the gentleman for his testimony. 

Mr. Daly, you are recognized for 5 minutes to summarize your 

opening statement, please. 

STATEMENT OF PATRICK DALY 

Mr. DALY. Thank you, Chairman Burgess and Ranking Member 

Green and members of the committee, for the opportunity to testify 

today. 

My name is Patrick Daly, and I am the president and CEO of 

Cohera Medical. Cohera Medical is a rapidly growing, North-Carolina-based medical device company with 36 full-time employees and 

over 18 contract employees. Cohera Medical develops surgical adhesives and sealants, including the first synthetic adhesive approved 

for internal use. 

I am pleased to testify today on the Medical Device User Fee 

Agreement on behalf of AdvaMed. Collectively, the medical device 

industry is committed to ensuring patient access to lifesaving and 

life-enhancing devices and other advanced medical technologies. I 

am very optimistic about what this industry can do for patients if 

the right policies are in place. 

I have been encouraged by the progress at FDA’s Device Center 

in recent years, but the innovation ecosystem that supports our industry remains stressed. One key barometer of the health of our 

ecosystem is the level of investment in startup companies. Unfortunately, we have seen a sharp decline in the number of new medical 

device technology startup companies each year and decreased venture capital investment. The time horizon for getting a new innovation from the bench to the bedside remains far too long. And as a 

result, investors are looking elsewhere. 

Despite these concerning statistics, we believe we are on the 

right track at FDA’s Device Center and that recent progress, combined with the provisions of this new User Fee Agreement, promise 

to keep things headed in the right direction and strengthen the 

medtech innovation ecosystem. 

Of course, there are many areas where FDA could further enhance the predictability and efficacy of its review process, and the 

new MDUFA IV agreement lays out the groundwork for further 

FDA performance improvements through five key areas: more ambitious goals, greater patient involvement, important process 

changes, and increased accountability, all supported by additional 

resources. And I would like to quickly describe these five key areas. 

First, MDUFA IV goals for total time reviewing product represent substantial improvements over current performances. Measuring the total time from submission to FDA decision to either 

make the technology available to the patients or deny approval is 

the most meaningful measure of progress. 

For 510(k) products, the total time goal of MDUFA IV decreased 

by 13 percent, which returns the total time to historical norms. For 

PMA products, which are the most innovative and high-risk products, the total time to decision goal was lowered by 25 percent. 

Second, as we all know, patients have a critical voice in product 

development and evaluation. This MDUFA IV agreement will have 

increased resources dedicated to supporting patient involvement in 

the medical device regulatory process. 

75 

Third, the agreement includes process improvements that we anticipate will enhance the consistency and timeliness of the review 

process independent of the specific time goals. One example of a 

process improvement, that the agreement provides for meaningful 

pre-submission interaction between FDA and companies. Interactions between the sponsor of the medical device application and 

the FDA prior to formal submission of a product application can 

provide helpful guidance that aids the sponsor in ensuring their application contains all necessary information. This pre-submission 

process was first put into place 5 years ago in MDUFA III and has 

benefitted both industry and FDA. This MDUFA IV agreement 

builds upon this success by adding in specific time commitments 

tied to pre-submission meetings. 

Fourth, the agreement provides for greater accountability. Greater accountability means that FDA’s success under the agreement 

will be transparent to FDA management, to industry, to patients, 

and to Congress and the administration, so that any problems that 

arise can be corrected promptly. New reporting tools and two independent management reports will provide key data to track FDA 

performance, highlight any failures to meet key goals, and provide 

the basis for corrective actions. 

Lastly, to give FDA additional tools to meet these goals, the 

agreement provides additional funds for FDA. These resources will 

give FDA what it needs to continue to improve performance. Each 

of the provisions of this agreement has the potential to make a difference in continuing to improve FDA performance, but the whole 

is truly greater than some of its parts. Each of the elements of the 

agreement reinforces the other. And, of course, no agreement, no 

matter how good on paper, is self-executing. Making it work as intended will require the full efforts of FDA’s dedicated staff and 

managers. Our industry is committed to work with FDA in any 

way we can to make it a success. Continued oversight and interest 

from Congress will also be important. Patients are depending on 

us. 

Finally, I should note that we are appreciative of the efforts by 

all Members who seek to give the FDA the tools and structure it 

needs to succeed. Legislative reforms that do not alter the substance of the negotiated agreement between FDA and industry hold 

the potential to create a legislative reauthorization package that 

maximizes the opportunity for success at the agency. 

I appreciate the committee’s work in considering these and other 

important measures that enhance and complement the underlying 

User Fee Agreement. 

I want to thank the committee for their time today. 

[The prepared statement of Mr. Daly follows:] 

76 


25747.030

Testimony of Patrick Daly, Cohera Medical 

House Energy & Commerce Health Subcommittee Hearing 

"Examining FDA's Medical Device User Fee Program" 

3.28.17 

Thank you Chairman Burgess and Ranking Member Green and members of the Committee for 

the opportunity to testify today. 

My name is Patrick Daly, and I am the President and CEO ofCohera Medical. Cohera Medical 

is a rapidly growing, North Carolina based medical device company with 36 full time employees 

and over 18 contract employees. We develop surgical adhesives and sealants, including the first 

synthetic adhesive approved for internal use. 

I'm pleased to testify today on the medical device user fee agreement on behalf of AdvaMed, 

which we, along with our sister associations MIT A and MDMA, negotiated with FDA. 

I thank you for convening today's hearing, and for your interest in improving medical device 

regulation for patients and industry. 

The U.S. Medical Technology Industry 

AdvaMed's member companies produce the medical devices, diagnostic products, and digital 

health technologies that are transforming health care through earlier disease detection, less 

invasive procedures, and more effective treatments. Our members range ftom the largest to the 

smallest medical technology innovators and companies. Collectively, we are committed to 

ensuring patient access to life-saving and life-enhancing devices and other advanced medical 

technologies. 

I am very optimistic about what this industry can do for patients if the right policies are in place. 

Fundamental advances in knowledge of human biology down to the molecular level and 

continued progress in a range of disciplines- computing, communications, materials science, 

physics and engineering- are fueling innovation, and the potential to save and improve patients' 

lives is almost limitless. 

Patient access to advanced medical technology improves outcomes, enhances care quality, and 

generates efficiencies and cost savings for the health care system. For example, between 1980 

and 2010, advanced medical technology helped cut the number of days people spent in hospitals 

by more than half and added five years to U.S. life expectancy while reducing fatalities ftom 

heart disease and stroke by more than half. 

I've been encouraged by progress at FDA's device center in recent years, but the innovation 

ecosystem that supports our industry remains stressed. One key barometer of the health of our 

ecosystem is the level of investment in start-up companies. Unfortunately, we have seen a sharp 

1 
77 


25747.031

decline in the number of new medical technology start-up companies each year, going from 

around 1,500 annually 30 years ago to around 600. Since the early 1990s venture capital (VC) 

investment in the industry has gone from about l3 percent of total VC dollars to about 4 percent 

in recent years. The time horizon for getting a new innovation from the bench to the bedside 

remains too long, and as a result investors are looking elsewhere. 

FDA Regulation of Medical Devices MDUFA IV 

We believe we are on the right track at FDA's device center, and that recent progress combined 

with the provisions ofthis new user fee agreement promise to keep things heading in the right 

direction to strengthen the medtech innovation ecosystem. 

The ground-breaking process improvements that were built into the MDUFA III agreement, and 

the oversight done by this Committee, have led to improvements in FDA's regulation of medical 

devices. FDA has brought down the total time it takes to receive a decision from FDA on a 

product submission, while still maintaining the strongest standards for evaluating safety and 

effectiveness. Opportunities for engagement between applicants and FDA throughout the device 

review process have increased, leading to fewer misunderstandings and false starts, and a better 

understanding of FDA data needs. As a result, the consistency and predictability of the FDA 

review process has shown improvement. 

Of course, there are many areas where FDA could further enhance the predictability and 

efficiency of its review process, and the new MDUFA IV agreement lays the groundwork for 

further FDA performance improvements through more ambitious goals, important process 

changes, and increased accountability, supported by additional resources. 

This agreement is good for industry. It is good for FDA. And most of all, it is good for patients. 

We urge this Committee and the Congress as a whole to act promptly to reauthorize the user fee 

program and enact this agreement into law. Failure to act would not only jeopardize the critical 

improvements made by the new agreement but would have a devastating impact on our 

industry's ability to bring innovative diagnostics, treatments and cures to patients. 

The user fee agreement builds the conditions for success in a number major ways: 

Significant Improvements for Total Review Time Goals 

Measuring the total time from submission to an FDA decision to either make that technology 

available to patients or deny approval is the most meaningful measure of the process. Total time 

goals were first included in MDUF A five years ago, and have been a meaningful measure for 

both industry and FDA. Building on the total time goal, this MDUF A IV agreement will 

continue to drive towards reducing the total time that is spent reviewing a submission. 

2 
78 


25747.032

The MDUF A IV goals for total time reviewing a product represent substantial improvements 

over current performance. For 51 O(k) products, which are moderate risk medical devices, the 

total time goal is currently 124 days. The MDUFA IV agreement lowers that goal to 108 days 

by the fifth year. This represents a 13% decrease, which returns the total time to historical 

norms. 

For PMA products, which are the most innovative and highest risk products, the total time to 

decision goal is currently 385 days. The MDUFA IV agreement lowers that goal to 290 days by 

the fifth year. This represents a 25% decrease. 

And for the first time, the MDUF A IV agreement includes goals for de novo products, which are 

generally moderate risk products but brand new innovations, which FDA has never evaluated 

before. 

Patient Input and Involvement in the Regulatory Process 

As we all know, patients have a critical voice in product development and evaluation. This 

MDUF A IV agreement will have increased resources dedicated to supporting patient 

involvement in the medical device regulatory process. FDA's device center has taken several 

steps to incorporate the patient perspective into the device review process, through efforts such 

as voluntary patient preference information and voluntary patient reported outcomes, and this 

agreement will continue to support that work. 

Process Improvements 

Third, the agreement includes process improvements that we anticipate will enhance the 

consistency and timeliness of the review process, independent of the specific time goals. 

One such example is that the agreement provides for meaningful presubmission interactions 

between FDA and companies. Interactions between the sponsor of a medical device application 

and the FDA, prior to the formal submission of a product application, can provide helpful 

guidance that aids the sponsor in ensuring their application contains all necessary information. 

This presubmission process was first put into place five years ago, in MDUFA III, and has 

benefitted both industry and the FDA. This MDUFA IV agreement builds upon this success by 

adding in a specific time commitment tied to pre-submission meetings. Under the MDUFA IV 

agreement, FDA will be required to provide meaningful, written feedback to companies at least 

five days prior to a presubmission meeting, ensuring that the meeting will be a productive one. 

Additionally, the agreement supports FDA's efforts to establish a National Evaluation System 

for Health Technologies, or the NEST. MDUFA funding will be used for a pilot to assess 

whether real-world evidence can be used to support premarket activities. This NEST pilot will 

determine the usability of real-world evidence for expanded indications for use, new clearances 

and approvals, and improved adverse event reporting. 

3 
79 


25747.033

Greater Accountability 

Fourth, the agreement provides for greater accountability. Greater accountability means that 

FDA's success under this agreement will be transparent to FDA management, to industry, to 

patients, and to Congress and the Administration, so that any problems that arise can be 

corrected promptly. New reporting tools and two independent management reports will provide 

key data to track FDA performance, highlight any failures to meet key goals, and provide the 

basis for corrective actions. 

One of these critical accountability measures involves process reforms for deficiency letters, or 

letters that applicants receive when their submission is found by FDA to be lacking needed 

information. Under this MDUFA IV agreement, all deficiency letters will include a statement of 

what information was provided in a submission and why it is not sufficient, including specific 

reference to the basis for the deficiency determination. Additionally, all deficiencies will 

undergo supervisory review by management prior to being issued. These provisions ensure that 

deficiency letters focus on real data needs and that FDA is clear on what data they require. 

In addition, the agreement provides for two analyses of FDA's management of the device review 

process. This review, or independent assessment, was a critical part of the MDUFA III 

agreement that helped lead to improvements in FDA performance. The MDUF A IV agreement 

continues this success by including funds for two additional independent reviews, one at the 

beginning ofMDUF A IV and one at the end. 

Enhanced Resources 

Finally, to give FDA additional tools to meet the new goals, the agreement provides $999.5 

million (FYJ5 dollars) in user fees for 2018-2022. This is built off of a baseline of approximately 

$679 million from MDUFA III, along with an additional $228 million in new resources to 

improve the device review process. In addition, there are $92.5 million in onetime costs for 

items such as IT and infrastructure improvements. Collectively, the resources will give FDA 

what it needs to continue to improve performance. 

Each of the provisions of this agreement has the potential to make a difference in continuing to 

improve FDA performance. But the whole is truly greater than the sum of its parts. Each of the 

elements of the agreement reinforces the others. 

And, of course, no agreement, no matter how good on paper, is self-executing. Making it work as 

intended will require the full efforts of FDA's dedicated staff and managers. Our industry is 

committed to work with FDA in any way we can to make it a success. Continued oversight and 

interest from the Congress will also be important. Patients are depending on all of us. 

Conclusion 

4 
80 


25747.034

Finally, I should note that we are appreciative of efforts by all Members who seek to give the 

FDA the tools and structure it needs to succeed. Legislative reforms that do not alter the 

substance of the negotiated agreement between FDA and industry hold the potential to create a 

legislative reauthorization package that maximizes the opportunity for success at the agency, 

which should be the shared goal of all involved. 

For example, legislation has been proposed to improve the consistency and transparency of FDA 

inspections of medical device facilities and to move to a risk-based system for device 

inspections. These common-sense proposals will ensure that FDA's inspections resources are 

best targeted to public health needs and that companies and FDA are working together. 

I appreciate the committee's work in considering these and other appropriate measures that 

enhance and compliment the underlying user fee agreement, and its focus on enactment of this 

legislative package as soon as possible. 

To reiterate, the MDUF A IV agreement is good for industry. It is good for FDA. And most of all, 

it is good for patients. We strongly support the vital improvements made by the new agreement 

and believe that a failure to act would have a destructive impact on our industry's ability to bring 

new, innovative treatments and cures to patients. 

I thank the Committee for the opportunity to testify and urge you to act promptly to reauthorize 

this program, which is so critical to our industry, to the FDA, and to patients. 

5 
81 

Mr. BURGESS. Thank you, Mr. Daly, for your testimony. 

And now, I recognize Ms. Wurzburger for 5 minutes to summarize her written testimony. 

STATEMENT OF DIANE WURZBURGER 

Ms. WURZBURGER. Chairman Burgess, Ranking Member Green, 

and distinguished members of the subcommittee, thank you for the 

opportunity to appear before you today to discuss the FDA’s Medical Device User Fee Program. 

I am Diane Wurzburger, executive, Regulatory Affairs for GE 

Healthcare. I am here today to testify in support of the MDUFA 

IV agreement and on behalf of the Medical Imaging and Technology Alliance. I served as a MITA industry representative to the 

MDUFA IV negotiations with FDA. 

MITA is the collective voice of medical imaging equipment and 

radiopharmaceutical manufacturers, innovators, and product developers. These technologies include MRI, x ray, CT, ultrasound, nuclear imaging, radiopharmaceuticals, and imaging information systems. 

Advancements in medical imaging are transforming health care 

through earlier disease detection, less invasive procedures, and 

more effective treatments. The industry is extremely important to 

American health care and noted for its continual drive for innovation, fast-as-possible product introduction cycles, complex technologies, and multifaceted supply chains. Individually and collectively, these attributes result in unique concerns as the industry 

strives towards the goal of providing patients with the safest, most 

advanced medical imaging currently available. 

MITA continues our strong support for an effective, wellresourced FDA capable of fulfilling its mission to protect and promote the public health. The medical imaging industry supported 

enactment of FDA’s User Fee Program in 2002 and its subsequent 

reauthorizations in 2007 and 2012. We participated in the MDUFA 

IV negotiations and believe that this agreement, if enacted, will improve FDA review of medical devices, assuring that American patients have timely access to safe and effective medical devices. 

User fees provide for a more efficient pre-market clearance process, allowing for lifesaving devices to get to market more quickly. 

We believe that enhanced FDA funding provides stability and predictability to the device review process and to timeliness. Without 

a consistent and timely FDA review process conducted by a welltrained staff, access to new diagnostic imaging equipment is delayed and industry’s ability to deliver technological advancements 

is compromised. 

With this in mind, the medical imaging community has been consistent in its desire for more predictability, consistency, transparency, and timeliness throughout the device pre-market review 

process. MITA and its members believe that all MDUFA commitments should be backed by appropriate, measurable, and predictable performance goals that support these principles. 

We are particularly pleased to see performance metrics for reduction in total time to review for 510(k)s to 108 days. The MDUFA 

IV agreement will make key improvements to the device review 

program, providing the agency with resources necessary to expedite 

82 

the pre-market process while maintaining FDA’s standards for 

safety and effectiveness. 

Similarly, we support the metrics for the pre-submission program. A pre-submission provides the opportunity for a manufacturer to obtain feedback prior to the submission of a device application. This program has brought value to industry and will continue 

to do so in a more predictable, consistent, and timely way with specific measurable metrics under the MDUFA IV agreement. 

MITA fully supports the center-wide Quality Management Program. We believe that an effective quality management framework 

will support more consistent and predictable device review. The 

FDA will identify an annual audit plan and conduct those audits 

with an eye for sharing high-performing pre-market review processes between divisions in the agency. MITA believes that identifying good practices throughout the agency and sharing them will 

lead to improved efficiency and effectiveness. 

Included in the MDUFA IV agreement is the establishment of an 

accreditation scheme for conformity assessment program. This program allows for devices to be evaluated according to specific recognized standards by certified testing laboratories. FDA has agreed 

not to review full test reports from these laboratories except as 

part of a periodic audit. MITA is a strong proponent of the use of 

voluntary consensus standards and believes that the ASCA program will reduce time to decision and provide more predictability 

to the process. 

Finally, MITA believes that a third-party independent assessment is critical to determine whether the investment in the premarket review program is providing a more consistent, predictable, 

and timely decision by the FDA. We look forward to participating 

in the comprehensive assessment of this process for the review of 

device applications and think it is important to not only complete 

the evaluation that was started under MDUFA III, but to also 

begin evaluating the programs funded by MDUFA IV. 

We believe that the MDUFA IV agreement will lead to an improvement in patient access to safe and effective medical devices. 

Most importantly, we are committed to ensuring the ultimate beneficiaries of these negotiations, the American public, benefit from 

continued improvements and timely access to the innovative devices and diagnostics necessary for the public health. MITA urges 

Congress to move quickly to reauthorize MDUFA IV. 

Thank you for the opportunity to present our views today. I am 

happy to answer any questions you have. 

[The prepared statement of Ms. Wurzburger follows:] 

83 


25747.035

STATEMENT 

OF 

DIANE WURZBURGER 

EXECUTIVE OF REGULATORY AFFAIRS FOR GE HEAL THCARE 

ON BEHALF OF 

THE MEDICAL IMAGING & TECHNOLOGY ALLIANCE (MITA) 

REGARDING A HEARING ON 

"Examining FDA's Medical Device User Fee Program" 

BEFORE THE 

U.S. HOUSE OF REPRESENTATIVES 

COMMITTEE ON ENERGY AND COMMERCE 

SUBCOMMITTEE ON HEALTH 

Tuesday, March 28, 2017 
84 


25747.036

Summary of Testimony: 

The Medical Imaging and Technology Alliance (MIT A) represents manufacturers of 

medical imaging equipment and radiopharmaceuticals. Without a consistent and timely FDA 

review process, conducted by a well trained staff, access to new diagnostic imaging equipment is 

delayed and industry's ability to deliver technological advancements is compromised. 

The medical imaging community has been consistent in its desire for more predictability, 

consistency, transparency and timeliness throughout the device premarket review process. MIT A 

and its members believe that all MDUF A commitments should be backed by appropriate, 

measureable and predictable performance goals that support these principles. MITA worked in 

good faith with other industry stakeholders and the FDA to negotiate the MDUF A IV agreement. 

We are particularly interested in: 

• Reduction in 51 O(k) total time to approval; 

• Performance metrics for the pre-submission process; 

• The center-wide Quality Management program; 

• The Accreditation Scheme for Conformity Assessment (ASCA) Program; and 

• Third party independent assessment 

We are committed to ensuring the ultimate beneficiaries of these negotiations, the 

American public, benefit from continued improvements in timely access to the innovative devices 

and diagnostics necessary for the public health. MIT A urges Congress to move quickly to 

reauthorize MDUFA IV. This agreement, negotiated between FDA and the medical device 

industry, advances our shared goals of ensuring that patients have timely access to the most 

innovative devices and diagnostics necessary for the public health. 
85 


25747.037

Chairman Burgess, Ranking Member Green, and distinguished members of the 

Subcommittee: 

Thank you for the opportunity to appear before you today to discuss the FDA's Medical 

Device and User Fee program. I am Diane Wurzburger, J.D., RAC, Executive of Regulatory 

Affairs forGE Healthcare. I'm here today to testifY on behalf of the Medical Imaging and 

Technology Alliance (MIT A). I am an active MIT A membet'; serving on the Board of Directors as 

well as Chair of the Technical and Regulatory Committee. I served as a MITA industry 

representative to the MDUF A IV negotiations with FDA. 

MIT A is the collective voice of medical imaging equipment and radiopharmaceutical 

manufacturers, innovators and product developers. It represents companies whose sales comprise 

more than 90 percent of the global market for medical imaging technology. These technologies 

include: magnetic resonance imaging (MRI), medical X-Ray·equipment, computed tomography 

(CT) scanners, ultrasound, nuclear imaging, radiopharmaceuticals, and imaging information 

systems. Advancements in medical imaging are transforming health care through earlier disease 

detection, less invasive procedures and more effective treatments. The industry is extremely 

important to American healthcare and noted for its continual drive for innovation, fast-aspossible product introduction cycles, complex technologies, and multifaceted supply chains. 

Individually and collectively, these attributes result in unique concerns as the industry strives 

toward the goal of providing patients with the safest, most advanced medical imaging currently 

available. 

Value of Medical Imaging: 

Medical imaging helps detect and diagnose disease at its earliest, most treatable stages 

and guides physicians and patients in determining the most appropriate and effective care. Our 
86 


25747.038

technologies are fundamental to standards of care. By catching disease early, reducing the need 

for invasive, in-patient procedures and facilitating shorter recovery times, medical imaging saves 

money and improves efficiency in the health care system. Medical imaging technologies have 

revolutionized health care delivery in America and around the world. Extending human vision 

into the very nature of disease, medical imaging enables a new and more powerful generation of 

diagnosis and intervention. 

Over the last 20 years, imaging has contributed to significant advances in healthcare 

delivery, leading to better health outcomes and reduced costs. For example, 20 years ago, an Xray was used to detect lung nodules, but was limited in its capacity to detect small nodules. Now, 

low dose lung computed tomography (CT) finds tiny tumors the size of a grain of rice. This 

reduces lung cancer deaths by 20% compared to chest x-ray. 

Today, technology that was once unimaginable is now the medical standard of care. The 

next generation of imaging technologies will further advance healthcare and the practice of 

medicine. A consistent and timely FDA review process is essential to timely patient access to 

these devices. 

MDUFA: 

MIT A continues our strong support for an effective, well-resourced FDA capable of 

fulfilling its mission to protect and promote the public health. The medical imaging industry 

supported enactment of FDA's user fee program in 2002 and its subsequent reauthorizations in 

2007 and 2012. We participated in the MDUFA IV negotiations and believe that this agreement, 

if enacted, will improve FDA review of medical devices, ensuring that American patients have 

timely access to safe and effective medical devices. We support the FDA in proposing this 
87 


25747.039

agreement to Congress and we will continue to partner with FDA and other stakeholders in 

asking Congress to reauthorize this important program. 

User fees provide for a more efficient pre-market clearance process allowing for lifesaving devices to get to market more quickly. We believe that enhanced FDA funding brings 

stability and predictability to the device review process and time lines. The goals that the medical 

device industry and FDA agree on and FDA's subsequent performance are critical to timely 

patient access to safe and effective medical advancements. Without a consistent and timely FDA 

review process, conducted by a well trained staff, access to new diagnostic imaging equipment is 

delayed and industry's ability to deliver technological advancements is compromised. 

MDUFAIV: 

With this in mind, the medical imaging community has been consistent in its desire for 

more predictability, consistency, transparency and timeliness throughout the device premarket 

review process. MIT A and its members believe that all MDUFA commitments should be backed 

by appropriate, measureable and predictable performance goals that support the principles of 

predictability, consistency, transparency and timeliness. 

We are particularly pleased to see performance metrics for reduction in total time to 

review for 51 O(k)s to I 08 days. The MDUF A IV agreement will make key improvements to the 

device review program, providing the Agency will the resources necessary to expedite the premarket process while maintaining FDA's standards for safety and effectiveness. Similarly, we 

support the metrics for the pre-submission program. A pre-submission includes a formal written 

request from a device sponsor for feedback from the FDA which is provided either in writing or 

during a meeting or teleconference. A pre-submission provides the opportunity for a 

manufacturer to obtain feedback prior to the submission of a device application. This program 
88 


25747.040

has brought value to industry and will continue to do so in a more predictable, consistent and 

timely way with specific, measureable metrics under the MDUF A IV agreement. 

To support the reduction in total time to decision, MITA believes that the FDA intention 

to include the basis for deficiencies in all deficiency letters will lead to a more consistent 

approval process. Being able to trace deficiencies to specific sections of a rule, final guidance, 

recognized standard or scientific or regulatory issue will lead to reduced total time to decision, 

align reviewer practices across branches and divisions and provide more predictability for 

sponsors. 

Intense negotiations between FDA and industry led to the inclusion of a variety of 

programs in the MDUF A IV agreement that MIT A is committed to working with the FDA to 

implement. Real World Evidence, Patient Input, Digital Health and 3'd Party 501(k) Review have 

the potential to support MIT A's tenets of predictability, consistency, transparency and 

timeliness, and we look forward to participating in the development of appropriate infrastructure 

for these programs to ensure that they align with industry expectations, patient needs and support 

FDA's mission of protecting the public health by assuring the safety, effectiveness, quality and 

security of medical devices. 

MIT A fully supports the center-wide quality management program. We believe that an 

effective quality management framework will support more consistent and predictable device 

review. The FDA will identifY an annual audit plan and conduct those audits with an eye for 

sharing high-performing premarket review processes between divisions in the Agency. MIT A 

believes that identifying good practices throughout the Agency and sharing them will lead to 

improved efficiency and effectiveness. 
89 


25747.041

Included in the MDUF A IV agreement is the establishment of an Accreditation Scheme 

for Conformity Assessment (ASCA) Program 

. This program allows for devices to be evaluated according to specific recognized 

consensus standards by certified testing laboratories. FDA has agreed not to review full test 

reports from certified testing laboratories except as part of a periodic audit. MITA is a strong 

proponent of the use of voluntary consensus standards and believes that the ASCA program will 

reduce time to decision and provide more predictability to the process. 

Finally, MIT A believes that a third party independent assessment is critical to determine 

whether the investment in the premarket review program is providing a more consistent, 

predictable and timely decision by the FDA. We look forward to participating in the 

comprehensive assessment of the process for the review of device applications and think that it's 

important to not only complete the evaluation that was started under MDUF A III but to also 

begin evaluating the programs funded by MDUFA IV. 

MIT A maintains that the performance goals set forth in MDUF A IV are achievable and 

have easily understood and transparent metrics. These goals focus on reducing pre-market 

review times and improving the consistency of reviews. 

Advancements in medical imaging are transforming health care through earlier disease 

detection, less invasive procedures and more effective treatments. MIT A looks forward to 

working collaboratively with FDA and Congress to develop a robust legislative proposal 

providing improved performance goals and reasonable user fees for value. We believe that the 

MDUF A IV agreement will lead to an improvement in patient access to safe and effective 

medical devices. Most importantly we are committed to ensuring the ultimate beneficiaries of 
90 


25747.042

these negotiations, the American public, benefit from continued improvements in timely access 

to the innovative devices and diagnostics necessary for the public health. 

MIT A urges Congress to move quickly to reauthorize MDUF A IV. This agreement, 

negotiated between FDA and the medical device industry, advances our shared goals of ensuring 

that patients have timely access to the most innovative devices and diagnostics necessary for the 

public health. 

Thank you for the opportunity to present our views today. I am happy to answer any questions 

you may have. 
91 

Mr. BURGESS. The gentlelady yields back, and the Chair thanks 

all of our witnesses for their testimony today. 

And the Chair would note that Dr. Shuren has remained in the 

audience, and I certainly thank him for that. 

As we move into the question-and-answer portion for our second 

panel, I want to recognize Dr. Bucshon of Indiana. Five minutes for 

questions. 

Mr. BUCSHON. Thank you, Mr. Chairman. 

Mr. Daly, I know that the medical device industry is dominated 

by small companies. Indiana has over 300 medical device companies, including small companies all the way to some of the bigname companies that all of us know. 

So, my question is, I understand the MDUFA agreement has 

some provisions in there that are directed toward smaller companies. Can you explain these provisions that are helpful to smaller 

companies? 

Mr. DALY. Thank you very much. 

I think the overall climate at FDA is helpful for small companies. 

Obviously, we do not have the staff that a larger company would. 

So, one example is what Dr. Shuren mentioned this morning, the 

pre-IDE meetings, having those communications prior to the meetings. Right now, we get those now five days in advance. It allows 

us to prepare. More importantly, it allows FDA to ask questions in 

a timely manner. I will give you an example. 

Prior to this, when we were still in a slower stage, we had a personal example of we flew my team down here for a meeting that 

we got the questions the night before. I don’t think it was as effective a meeting. 

And I do want to compliment Dr. Shuren, Dr. Maisel, and his entire staff, for really putting a lot of effort into this over the last 4 

or 5 years to make that a better process. 

Mr. BUCSHON. Thank you. 

And just a general question of interest to me, to anyone. I will 

start with you, Ms. Wurzburger. A more, what I would call, streamlined and effective review process that cuts down on the time to get 

a product to the marketplace, what would you estimate is the potential savings to overall medical costs and to your ability to get 

products to the market? Because if you stretch out a process and 

it takes you longer, it costs you more money. I mean, do you have 

any thoughts, just general thoughts, on that and the importance of 

a process that works as expediently as possible? 

Ms. WURZBURGER. I believe an efficient process, a more predictable process allows a manufacturer to plan internally for their own 

quality system processes and those other testing requirements that 

are needed to prepare that submission effectively. 

I would say that, just generally, with diagnostic imaging and the 

technologies, as we are able to bring those to the market more efficiently and more timely, that there is an impact on the overall 

healthcare costs, I believe, on the system, as we are able to have 

innovations that will better diagnose patients and perhaps impact 

a patient’s treatment plan more rapidly. 

Mr. BUCSHON. Yes, I think I will just comment on it. I was a cardiovascular and thoracic surgeon before I was in Congress. You 

can’t underestimate the long-term savings of getting really innovaVerDate Mar 15 2010 10:41 Oct 19, 2018 Jkt 037690 PO 00000 Frm 00095 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X20USERFEES\115X20USERFEESWORKING WAYNE
92 

tive products to patients earlier, and some people have mentioned 

that. If it improves people’s quality of life and keeps them out of 

the hospital and keeps them from getting constantly more expensive medical care over a prolonged period of time, which could be 

decades even, that is something that I think is extremely important. 

Does anyone else have any comments on the—yes, Mr. Kieval? 

Mr. KIEVAL. Thank you. 

Yes, first off, with the diseases that we treat, particularly heart 

failure, you know, survival is a big problem. I mean, annual mortality rates and heart failure can be over 10 percent. Five-year 

mortality is over 50 percent. So, really, time is life with our therapies. 

And to your point, our therapies are intended to return patients 

to full life, keep them out of the hospital, which is a major source 

of financial burden to the healthcare system. 

Even as a small company with the most efficient operations that 

we can muster, our monthly burden rate exceeds a million dollars 

a month. So, every month of delay due to—whether it is for good 

reason or not for good reason—is another million-dollar turn of the 

crank for our company. That is money that is taken away from innovation and further efficiency in the system. So, I think that 

streamlining the system can have lots of benefits, from saving 

lives, improving lives, reducing costs, and fostering innovation. 

Mr. BUCSHON. I think it was you that mentioned the ability to 

attract venture capital investment in startup companies or smaller 

companies is impacted by this also, by this process, right? 

Mr. KIEVAL. Absolutely. I think, as we look, two big hurdles for 

companies in our position have both been talked about, regulatory 

approval and, then, reimbursement. And reimbursement is not the 

focus of this panel. 

But the more that we can do to provide a sense of assurance and 

confidence to prospective investors in the function of these processes, not necessarily in the outcome, but in the efficient function 

of these processes, the more they are going to be interested in returning to participate. 

Mr. BUCSHON. I yield back, Mr. Chairman. 

Mr. BURGESS. The gentleman yields back. The Chair thanks the 

gentleman. 

The Chair recognizes the gentleman from Houston, Texas, Mr. 

Green, the ranking member of the subcommittee. 

Mr. GREEN. Only because he is from Denton, Texas. So, we don’t 

have to have an interpreter—— 

[Laughter.] 

Mr. BURGESS. Recognized for 5 minutes for questions. 

Thank you. 

Mr. GREEN. Thank you, Mr. Chairman. 

Our committee and I worked on breakthrough pathway for device 

precision. It was in the 21st Century Cures. I am delighted the provision is now in law. 

Mr. Daly, in my understanding, your company received Expedited Access Pathway, or EAP, designation for one of your products 

which was a precursor to the breakthrough designation. Can you 

93 

explain what the EAP program is and what it means for your company? 

Mr. DALY. Congressman Green, thank you for the question. 

As a sidebar, I was a sales representative for Dr. DeBakey down 

in Houston 25 years ago. So, you brought back some memories. 

Mr. GREEN. I have a picture that is probably 25 years old. 

[Laughter.] 

Mr. DALY. So, the Expedited Access Pathway, you know, basically, for us, as our company, our product is called Sylys. It is a 

second PMA product, a pre-market-approved product that we have. 

What it does is it is a sealant that goes around a stable or suture 

line for colorectal surgery or gastric bypass surgery. What this does 

is it reduces leaks by 70 percent. 

What this has been able to do through the EAP program is take 

about a year and a half off the process for us to get into a pilot 

study. As was mentioned here, at a million dollars a month, that 

is a significant savings. 

We are really excited that we were the first product approved 

through EAP program, and we are working through that. What it 

has done, too, for us, as an investor or as a company, is we have 

brought in some pretty significant investment. Over $50 million 

came because of our EAP designation. So, it has been a very big 

windfall for us. 

Mr. GREEN. It is not often that Members of Congress hear something that goes right. Normally, we hear that it goes wrong. And 

thank you and I am excited about the potential not only for you, 

but the breakthrough pathway for medical devices and these agreements here. 

Mr. Kieval, you mentioned in your testimony that agreement includes new performance goals aimed at getting new technologies to 

patients by including updated decision time targets for 510(k)s and 

PMAs and review time goals for de novo technologies and pre-submissions. Can you elaborate on these enhanced performance goals 

and how you feel they would benefit industry and the patients? 

Mr. KIEVAL. Yes, thank you for that question. By the way, we are 

also participating in the Expedited Access Pathway Program. 

Mr. GREEN. Great. 

Mr. KIEVAL. And I would echo Mr. Daly’s comments on that. 

So, from my perspective, I think speed is a great byproduct of an 

improved regulatory process, but I am not sure that, you know, I 

interpret the new performance goals under MDUFA IV as speed for 

speed’s sake. I think there are important improvements to the process, important efficiencies to be gained, and that we can expect, as 

a result, greater speed because there is less wasted time, less unnecessary questions in going back and forth between innovators 

and the FDA. 

So, the goals are meaningful because, once again, it is going to 

enhance access to patients whose lives hang in the balance, at least 

with the diseases that we are treating. It is going to make sure 

that resources are used most efficiently for innovation purposes. It 

is going to provide predictability for the investment community. So, 

I think it is going to have, these new goals are going to have myriad forms of benefits, but, again, as a byproduct of an improved 

process, not as a means to an end in and of themselves. 

94 

Mr. GREEN. Thank you. 

Ms. Wurzburger, do you have anything to add to that question? 

Ms. WURZBURGER. No, I would just echo that I think that, although we are a larger organization than some of the small companies represented by my colleagues here, for us as well an efficient 

process allows us to reinvest in our innovations, in our R&D, resources that we need internally to ensure our products are safe and 

effective coming out the door. 

Mr. GREEN. Ms. Bens, the Alliance for Aging Research has been 

a leading advocate for the inclusion of patient views on the benefits 

and risks of devices during the product reviews. Can you talk about 

how this agreement builds on MDUFA III to expand patient-centered medical device development? 

Ms. BENS. Absolutely. Thank you very much for the question. 

The one thing that I point to that was most beneficial to organizations like ours was the ability to interact with CDRH right from 

the start in defining what the unmet needs were for patients as 

well as what their most important benefits were that they were 

going to potentially see from medical products. 

And I would give Dr. Shuren and the rest of the staff at CDRH 

a lot of credit for how comprehensive that risk/benefit guidance 

really was and setting the stage for a framework where not only 

developers can really be pointing to the criteria that CDRH was 

going to use for evaluating benefit/risk, but also groups like ours 

could play more of a proactive role in identifying different types of 

research that could better fill those gaps and lead to endpoints that 

were going to be more meaningful to patients. 

And I would say the next step that CDRH really took was the 

establishment of their Patient Engagement Advisory Council. That 

is something that we are really excited about, and we know that 

they are already in the process of planning their first meeting. But 

this will take the additional step of really implementing that guidance in a way that is going to be transformative. 

I know there was a little bit of talk earlier about the issue of 

guidance and the FDA’s ability to issue guidance. And this is one 

area where the PEAC is going to be a bit different from other types 

of patient engagement activities at the FDA. There is really going 

to be the opportunity for patients and their representatives to have 

a seat at the table in helping to provide guidance to the Commissioner on how they can develop guidances that are truly going to 

be patient-centered and lead to better studies. So, we are really excited about that. And the MDUFA fee funds really going hand-inhand with funding those types of activities. 

Mr. GREEN. Thank you, Mr. Chairman, and I thank our witnesses for being here. 

Mr. BURGESS. The gentleman yields back. 

The Chair recognizes himself for 5 minutes for purposes of questions. And let me ask a question of our three industry representatives, because this is apropos of you and, then, Ms. Bens, I am 

going to include you in something in just a moment. 

But, of course, we are talking about the FDA, what the FDA/ 

CDRH can do to make its path more straightforward. But, as an 

industry, what are you all doing to make certain that your submisVerDate Mar 15 2010 10:41 Oct 19, 2018 Jkt 037690 PO 00000 Frm 00098 Fmt 6633 Sfmt 6633 I:\115THCONGRESS\115X20USERFEES\115X20USERFEESWORKING WAYNE
95 

sions are of the highest quality to lessen the likelihood of having 

to come back and retrace steps? 

Now, Ms. Wurzburger, let me start with you and, then, we will 

just go down the line. 

Ms. WURZBURGER. Sure. Thank you for the question. 

Yes, I think, as we have heard through some of the testimony, 

a lot of the processes that are funded through this new User Fee 

Program, such as the pre-submission process, is very, very useful 

for us as manufacturers. That interactive dialog with the agency 

and discussion around the endpoints they expect and the data that 

they are looking for in those submissions allows us to go back into 

our internal processes and ensure that the submissions we are putting together are robust and contain that information on the first 

round. We are constantly improving that, as we acquire additional 

feedback from the agency and from other sources. So, it is very 

helpful for us. 

Mr. BURGESS. Mr. Daly? 

Mr. DALY. Mr. Chairman, I think what you see collectively up 

here are companies that are part of trade organizations and organizations that really do, in my view, an excellent job, whether it is 

MITA or MDMA or AdvaMed, of taking the side that industry 

needs to also do a good job in presenting their either 510(k) or 

PMA. 

And so, if you look across all three of these particular agencies, 

they do a very good job of training new companies, providing companies access to the bigger company information. As an example, 

I am chairman of, within AdvaMed, Excel, which is a part of 

AdvaMed that is companies that have less than $100 million in 

revenue. It makes up about 80 percent of our membership for all 

of AdvaMed. So, they do a really good job of helping companies 

navigate and get the right information. 

Mr. BURGESS. Thank you. 

Mr. Kieval? 

Mr. KIEVAL. Yes, I think my colleagues really summarized those 

very well. We are a small company. We are a single-product company. This is all we have got. If we run out of money before we 

get it across the goal line—— 

Mr. BURGESS. Can I ask you about that? 

Mr. KIEVAL. Sure. 

Mr. BURGESS. Because, I mean, I was struck in your written testimony and your testimony here. I mean, you are right, you are a 

small company. You have got one thing. You have got one job, as 

they say. And so, if we make your life hard, harder, impossible, I 

mean, it has a profound effect, then, not just on you and your employees, but, of course, patients who depend on the products. 

And it sounds like—we haven’t really gotten into what the products are that your particular company is dealing with—but, I 

mean, in your testimony you said that the sweetest grandmother 

waiting for the device and someone else who was waiting for it. 

And these are outside the country. And so, our patients inside the 

country are still waiting for those devices, is that correct? 

Mr. KIEVAL. So, in our own experience, our products have been 

on the market for a few years outside the United States, in Europe. 

We are excited about being able to treat patients there. We are 

96 

very eager to have our products approved here in the United 

States. 

We are very fortunate to be, as part of the Expedited Access 

Pathway program, and we are in the middle of what we hope is our 

definitive clinical trial to bring our product to the U.S. market. So, 

we have continued throughout our 16-year history—it has always 

been a goal to bring our product here to the United States. I think 

it has been a difficult process. It has been a worthwhile process. 

We have welcomed the enhancements under MDUFA III. We are 

looking forward to the enhancements under MDUFA IV and working with the FDA to complete that development process to bring 

this innovation to U.S. patients. 

Mr. BURGESS. Well, I think I have heard it said more than once 

today on the panel in front of us the words ‘‘alleviate suffering’’. 

And, Ms. Wurzburger, I think in your testimony you talked about 

things that were at one time science fiction are now the standard 

of care. 

And when I talk to groups of medical students, residents, people 

sometimes despair of what they see on the policy side up here and 

we never agree on anything and we are fighting about everything. 

But, honestly, the next generation of doctors is going to have tools 

at their disposal that no generation of physicians has ever known, 

thanks to the work of the agency and thanks to the work of the 

innovators and the advocacy groups, the things that all of you put 

your heart and soul into. 

So, for that, I want to thank you. I want to thank you for being 

here today. 

I was going to recognize Mr. Carter, but he is exiting. He is 

exiting stage right, and he will submit for the record. 

Mr. Green is already gone. So, I can’t ask him for a followup. 

But it has been a fascinating day and a fascinating panel. I think 

you have heard throughout the discussion today how the goodwill 

exists to get this done. And while things may move into the headlines that like to highlight where we can’t agree on a single thing, 

this is something where we all agree. 

We have heard it said other times during the hearing that, yes, 

we welcome submissions and inputs. If people have better ideas, if 

there is a better way, talk to us. But, make no mistake about it, 

we are getting our work done. 

And again, I think I credit Dr. Shuren for staying here through 

the industry testimony. I think that is indicative of how everyone 

wants this process to not just conclude, but to conclude successfully. 

So, seeing that there are no further Members wishing to ask 

questions, I do want to thank our witnesses for being here today. 

And pursuant to committee rules, I remind Members they have 

10 business days to submit additional questions for the record. 

I ask witnesses to submit their responses within 10 business 

days of the receipt of those questions. And we had no unanimous 

consent requests? No unanimous consent requests. 

Without objection, the subcommittee is adjourned. 

[Whereupon, at 12:45 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

97 

[Dr. Shuren did not answer submitted questions for the record by 

the time of printing.] 


25747.043

GREG WALDEN, OREGON 

CHAIRMAN 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

(ongresil of tbe Wntteb ~tates 

Dr. Jeffrey E. Shuren 

Director 

~ou~t of ~epre~entattl:les' 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN HousE OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 

April 27,2017 

Center for Devices and Radiological Health 

Food and Drug Administration 

10903 New Hampshire Avenue 

Silver Spring, MD 20993 

Dear Dr. Shuren: 

Thank you for appearing before the Subcommittee on Health on March 28, 2017, to testify at the 

hearing entitled "Examining FDA's Medical Device User Fee Program." 

Pursuant to the Rules of the Conunittee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: {l) the name of the 

Member whose question you are addressing, (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing ofthe hearing record, please respond to these questions with a 

transmittal letter by the close of business on May II, 2017. Your responses should be mailed to Jay 

Gulshen, Legislative Clerk, Committee on Energy and Commerce, 2125 Raybum House Office Building, 

Washington, DC 20515 and e·mailed in Word format to jay.gulshen@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sinccrclyt 

~~'tr Chairman 

Subcommittee on Health 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attaclunent 
98 


25747.044

Attachment- Additional Questions for the Record 

The Honorable Gus Bilirakis 

1. Why l have a question related to the topic of 3rd party repair of medical devices. Based 

on the information obtained by the FDA in the open docket and insight gathered at the 

public forum, do you see a need for FDA intervention to protect patients? Why or why 

not? If so, can you provide the Committee with insight around specific problem areas 

and next steps lo address the axeas of concern? 

2. The Administration has imposed a "regulatory freeze" across the federal agencies, 

including the FDA. How docs the freeze potentially impact the FDA's ability to move to 

next steps to mitigate patient risks associated with these patient safety and third party 

repair? With critical patient safety issues at play, can you offer any insight into the 

timeline of where the FDA is on this issue and what steps the Agency is now 

contemplating to address this issue? 

The Honorable Richard Hudson 

Nmth Carolina is home to a vibrant life sciences industry and a large number of device 

companies. A priority for me is ensuring these companies have access to the most efficient 

review process possible. I understand that the MDUFA IV agreement continues the independent 

assessment process that was begun under MDUFA Ill, where an outside management consultant 

was brought in to evaluate the device review process. 

1. Did you find that independent assessment process helpful? 

2. Can you explain how it will be continued under this new MDUF A agreement? 

The Honorable Michael C. Burgess 

1. The overwhelming majority of medical device manufacturers are small, innovative 

companies that may only have one product on the market, if any, at a time. Can you talk 

about how FDA works with these types of companies to ensure a smooth submission and 

review process? How are small businesses accounted for in this proposed agreement? 

The Honorable Frank Pallone, .Jr. 

National Evaluation System for hcaltl1 Technologies (NEST) 

The National Evaluation System for health Technologies, or NEST, is a nongovernment system 

nm by external stakeholders that will utilize real world data collected during clinical care that 

can be used in the pre-market review of medical devices, as well as post-market reporting and 

safety monitoring. I understand that the standing up of NEST has been a priority for the agency. 

Ql: How will a robust NEST help with pre-market medical device reviews, as well as 

post-market safety monitoring of medical devices? 
99 


25747.045

Q2: I \lndcrstand that funding for NEST under MDUF A IV is limited to pre-market 

activities. Given the potential for NEST to help with post-market surveillance, 

why did MDUFA IV limit funding for NEST to pre-market activities? 

Third Party Review 

Under current law, FDA accredits external third parties to conduct reviews of certain low and 

moderate risk devices if desired by the device developer. The goal ofthis program was to al!ow 

FDA to prioritize its resources for higher-risk and complex device reviews, and to improve the 

review of low and moderate risk devices. 

MDUF A IV outlines a number of steps the agency will take to improve the Third Party Review 

Program, including increased training for third parties, issuing guidance for accreditation criteria, 

and eliminating routine re-review. The commitment letter also notes that the agency intends to 

tailor the progmm. 

Ql: Please describe further how the Third Party Review program was intended to 

work, as well as any issues FDA has identified with how tlle program is working 

currently. 

Q2: How will MDUF A IV help to address the issues identified by the agency and 

ensure that the Third Party Review program is reviewing devices appropriately? 

Pre-Submission Communication 

Timely and meaningful communication between FDA and sponsors is criticai to ensuring that 

both parties have a clear understanding of the standards and expectations for review, as well as 

the actions needed to receive timely approval of their device application. I understand that both 

FDA and industry agree that meaningful communication pre-submission can help to improve the 

efficiency of the device review process. 

Q 1: Can you please discuss further how the pre-submission process has been working 

in the MDUFA Program, and the steps MDUFA IV will take to further improve 

the pre-submission process? 

The Honorable Anna Eshoo 

FDA Pediatric ))evice Consortia Program 

l) Please describe some of the successes of the Pediatric Device Consortia program. 

2) Can you describe how the Pediatric Device Consmtia program has helped to support the 

development of pediatric medical devices? 
100 


25747.046

3) How has the consortia leveraged FDA's funding with other sources of funding to support 

pediatric medical device projects? 

Pediatric Device Extrapolation 

I) To what extent arc device companies using the pediatric extrapolation guidance to support the 

appropriate labeling of devices for use in children? 

2) Can you provide examples of how FDA's pediatric device extrapolation guidance has been 

used to approve pediatric labeling of medical devices? 

3) How does the FDA currently inform companies that they can use pediatric device 

extrapolation? 

Lack of Progress on Pre-Market Application Labeling for Children 

I) In recent years, less than 5% of pre-market application (PMA) devices have been approved for 

usc in children under the age of 16. What improvements can be made to the FDA's approval 

process so that the agency is approving more PMAs labeled for children under the age of 16? 

2) What is the FDA doing to ensure that device technologies approved for adults and that could 

be beneficial in children arc being studied and labeled for use in children, regardless of whether 

it is lor the same disease or condition? 

Humanitarian Use Devices 

The Federal Food, Drug and Cosmetic Act requires to seek the approval of a local institutional 

review board (IRB) prior to using a humanitarian usc device (HUD). HUDs are devices intended 

to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in 

fewer than 4,000 individuals in the United States per year. 

IRBs exist to review research, so this requirement seems to imply that HUDs are experimental 

devices that arc not approved for marketing. This could negatively impact securing payment 

from insurers for HUDs, which thousands of patients rely on to treat rare disease and conditions. 

1) Are l!UDs experimental devices that are not approved for marketing? If they are not, are there 

other entities, other than IRBs, that are better suited to ensuring the safe use of HUDs? 

The Honorable G. K. Butterfield 

l. Do you believe NEST can address clinical trial enrollment efficiencies and can it be 

helpful in enabling greater diversity in clinical trials? How will PDUFA VI help with the 

development and approval of rare disease treatments? 

2. Does the agreement also include funding to protect patient information used for realworld evidence? 

2 
101 


25747.047

3. Can you discuss the cunent process for FDA inspections of medical device 

manufacturers? 

4. Does FDA provide any sort of advance waming to manufactmers before inspections 

occur? 

5. Does FDA inspect all manufacturers with the same level of regularity and in the same 

manner? 

6. I understand that hearing loss is not simple, where one description fits everyone's 

medical issue. You can have problems with the middle ear or in the inner ear or the 

hearing nerve or even a combination of the two. There are different treatment strategies 

for each. Then there's the issue of diagnosing the severity of the hearing loss in each ear, 

and it can be different in each ear. 111at's a lot of self-diagnosis to expect from 

consumers. What data exists to demonstrate that patients can(!) distinguish between 

conductive, sensorineural, and mixed hearing loss and (2) calibrate the severity of their 

hearing impairment so that they can self-treat with a hearing aid? 

7. Primary care physicians are on the front lines of patient care, treating the whole patient 

over time, and refening to other providers when needed. They see the impact of hearing 

loss, and have recommended hearing loss screening be included in routine patient exams. 

The American Academy of Family Physicians practice recommendations also 

specifically state that older patients with likely hearing loss should be rcfelTed for 

audiometric testing. A recent study comparing professionally fitted hearing aids with 

pre-programmed out-of-the-box devices had each patient undergo the standard-of-care 

audiometric testing, It appears that pursuing this very broad category of OTC devices is 

designed to eliminate that step even when hearing Joss is interfering with an individual's 

ability to hear and participate in conversations. I am concerned that eliminating all 

testing looks a bit !ike an e.xperiment. If there isn't current scientlfie evidence that 

wanants ignoring recommendations of clinicians, what plans arc in place to ensure the 

data supports the broad OTC category belbre it's implemented? 

8. When you look at the various hearing loss severity scales, there is a 50 decibel range 

from the beginning of the "mild" category to the ceiling of the "moderate" category. Just 

20 decibels separates this range from normal hearing on one end and profound hearing 

loss on the other. That means that these OTC devices, even with output limits, will have 

the potential to do damage. What studies have been or are being done to determine the 

safeguards these devices will require for safety? 
102 

[Ms. Bens did not answer submitted questions for the record by 

the time of printing.] 


25747.048

GREG WALDEN, OREGON 

CHAIRMAN 

Ms. Cynthia Bens 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

ctr:ongress of tbe 1l!initeb ~tates 

JQou~t of l\tpre!5tntatil:lt~ 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN House OFFICE BuiLDING 

WASHINGTON, DC 20515-6115 ll0:l)21!H'927 

1202)225--3641 

April27, 2017 

Vice President of Public Policy 

Alliance for Aging Research 

1700 K Street, N.W. 

Suite740 

Washington, DC 20006 

Dear Ms. Bens: 

Thank you for appearing before the Subcommittee on Health on March 28, 2017, to testify at the 

hearing entitled "Examining FDA's Medical Device User Fee Program." 

Pursuant to the Rules of the Conm1ittee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (1) the name of the 

Member whose question you are addressing. (2) the complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing re<:ord, please respond to these questions with a 

transmittal letter by the close of business on May I I, 2017. Your responses should be mailed to Jay 

Gutshen, Legislative Clerk, Committee on Energy and Commerce, 2!25 Raybum House Office Building, 

Washington, DC 20515 and e-mailed in Word formal to jay.gulshen@mail.house.gov. 

Thank you again for your time and effort preparing and delivering testimony before the 

Subcommittee. 

Sincerely. 

/f:!(~ Michael C. Burgess. M.D. 

Clmirman 

Subcommittee on Health 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 
103 


25747.049

Attachment- Additional Questions for the Record 

The Honorable Frank Pallone, Jr. 

Hiring Freeze and MDUF A 

User fees under MDUFA also assist FDA in hiring and retaining the staff necessary to. support 

the activities associated with the review of medical device applications. Under MDUFA IV, 

FDA has agreed to hire up to 217 employees by fiscal year 2022. 

Ql: FDA has consistently had issues recruiting and retaining personnel in part due to 

the long hiring process, but largely due to the agency's inability to compete with 

the salaries of the private sector. While 21st Century Cures worked to address this 

issue, l am concerned that the federal hiring freeze proposed by this 

Administration endangers the ability for success. Can you discuss further what 

impact a federal hiring freeze could have on FDA and the medical device review 

process? 

Trump Budget 

1 have grave concems with the recent budget announcement from the Administration. In his 

proposal, the President proposes doubling user fees for medical product review to $2 billion, 

while simultaneously cutting the agency's budget authority. As you know, not all of FDA's 

critical public health responsibilities are funded witb user fee dollars. 

Ql: Will you please discuss further the types of public health activities at FDA that 

could be scaled back or negatively impacted by this proposal? 

Third Party Review 

Under current law, FDA accredits external third parties to conduct reviews of certain low and 

moderate risk devices if desired by the device developer. The goal of this program was to allow 

FDA to prioritize its resources for higher-risk and complex device reviews, and to improve the 

review of low and moderate risk devices. 

MDUFA IV outlines a number of steps the agency will take to improve the Third Party Review 

Program, including increased training for third parties, issuing guidance for accreditation criteria, 

and eliminating routine re-review. The commitment letter also notes the agency il1tends to tailor 

the program. 

Ql: Does the Alliance for Aging Research support the use of third parties in the 

medical device review process? Jf yes, please explain why. If no, please explain 

why. 

Q2: How do you think MDUFA IV will help to ensure that the Third Party Review 

program is reviewing devices appropriately? 
104 


25747.050

The Honorable G. K. Butterfield 

1. What do you envision the pilot project for real-world evidence looking like? How will 

real world evidence help to combat health disparities? 

2. How do you envision CDRH using patient input to inform clinical study design and how 

can that benefit your constituency? 

3. How do you intend to share patient preference information with the FDA? How can 

smaller patient advocacy organizations also participaie? 

4. How do you see NEST helping to increase enrollment ef1iciencies and do you believe it 

will be helpful in enabling greater diversity in clinical trials? 

5. You mention that currently on 40 percent of de novo requests are reviewed on time. 

MDUFA 4 sets the goal of reviewing 70 percent of de novo requests by 2020. What type 

of impact could that have on your constituency? 
105 

[Mr. Daly did not answer submitted questions for the record by 

the time of printing.] 


25747.051

GREG WALDEN, OREGON 

CHAIRMAN 

Mr. Patrick Daly 

President and CEO 

Cohera Medical 

ONE HUNDRED FIFTEENTH CONGRESS 

FRANK PALLONE, JR., NEW JERSEY 

RANKING MEMBER 

C!Congre~~ of tbt Wnttcb ~tate~ 

l!}oul'lt of l\tprtl'ltntatibel'l 

COMMITTEE ON ENERGY AND COMMERCE 

2125 RAYBURN House Omce BuiLDING 

WASHINGTON, DC 20515-6115 

April27, 2017 

227 Fayetteville Street 

Suite900 

Raleigh, NC 2760 l 

Dear Mr. Daly: 

Thank you for appearing before the Subcommittee on Health on March 28,2017, to testify at the 

hearing entitled "Examining FDA's Medical Device User Fee Program." 

Pursuant to the Rules of the Committee on Energy and Commerce, the hearing record remains 

open for ten business days to permit Members to submit additional questions for the record, which are 

attached. The format of your responses to these questions should be as follows: (l) the name ofthe 

Member whose question you are addressing, (2) tbe complete text of the question you are addressing in 

bold, and (3) your answer to that question in plain text. 

To facilitate the printing of the hearing record, please respond to these questions with a 

transmittal letter by the close of business on May ll, 2017. Your responses should be mailed to Jay 

Gulsben, Legislative Clerk, Committee on Energy and Commerce, 2125 Rayburn House Office Building, 

Washington, DC 20515 and e-mailed in Word tbrmat to jay.gulshen@mail.bouse.gov. 

ThMk you again for your time and effort preparing and delivering lestimony before the 

Subcommittee. 

Sincerely, 

~~ Michael C. Burgess, M.D. 

Chairman 

Subcommittee on llealth 

cc: The Honorable Gene Green, Ranking Member, Subcommittee on Health 

Attachment 
106 


25747.052

Attachment- Additional Questions for the Record 

The Honorable Richard Hudson 

!. Mr. Daly, first thank you being here. It's an honor to have a North Carolina company 

representing the device industry on this panel. The medical device community is made 

up of both large manufacturers and small ones like yours. The MDUFA agreement 

includes improvements to total time review goals. Can you comment on these total time 

goals and what they mean for companies like yours? 

The Honorable Frank Pallone, Jr. 

Hiring Freeze and MDUFA 

User fees under MDUF A also assist FDA in hiring and retaining the staff necessary to support 

the activities associated with the review of medical device applications. Under MDUFA IV, 

FDA bas agreed to hire up to 217 employees by fiscal year 2022. 

Q1: How did FDA and industry determine the number of additional employees that 

would be needed to help implement MDUFA IV recommendations? 

Q2: Why is the hiring of an additional217 employees at the Center for Devices and 

Radiological Health (CDRH) impmtant to the implementation ofMDUFA IV? 

Support for MDUFA IV 

Current statute outlines a detailed process for the reauthorization of the Medical Device User Fee 

Amendments. FDA is charged to not only negotiate with industry to develop recommendations, 

but also to solicit public input and bold public meetings, and consult periodically with Congress 

and patient and consumer groups, among others. The recommendations !hal are the result of this 

process must also be available publicly for a period of public comment, and ultimately are 

required by statute to be transmitted to Congress by January 15,2017. The process that led to the 

ultimate transmittal of the MDUF A IV recommendations kicked off over a year and a half ago in 

September 20 15. 

Ql: Will you discuss further industry's role in the reauthorization ofMDUFA, and in 

particular, the time line for these activities? 

Q2: As you know, the statute requires that the recommendations be transmitted to 

Congress no later than January 15, 2017, a deadline that FDA has already met. 

Does the statute allow FDA to transmit recommendations for the reauthorization 

ofMDUFA at an alternative date? 

Q3: MDUFA IV expires on September 30,2017. What would be the impact to your 

company, and the member companies at AdvaMed if Congress does not pass the 

reauthorization ofMDUFA before September 30'"? 

Q4: Do you support the MDUFA IV recommendations as transmitted to Congress? 
107 

Æ 


25747.053

Timeline for Review 

Prior to the establishment of MDUF A, the medical device program was suffering from a lag in 

medical device review time lines, a lack of expertise among FDA personnel, and insufficient 

resources to maintain the program. MDUFA was first enacted in 2002 and has since worked to 

address these issues. One area MDUFA has had clear success in is reducing the total time to 

decision for medical device applications. The average total time to a decision on a pre-market 

approval (PMA) in 2015 has been reduced by 35 percent or 150 days over six years, and the 

average total time to decision for a 51 O(k) in 2015 has been reduced by 11 percent over five 

years. 

Ql: The MDUFA IV agreement includes additional improvements on the total review 

time goals. Can you discuss further the improvements made itt MDUFA IV and 

what they mean for companies like yours? 

Pre-Submission Communication 

Timely and meaningful communication between FDA and sponsors is critical to ensuring that 

both parties have a clear understanding of the standards and expectations for review, as well as 

the actions needed to receive timely approval of their device application. I understand that both 

FDA and industry agree that meaningful communication pre-submission can help to improve the 

efficiency of the device review process. 

Ql: How has the pre-submission process been working from your perspective, and what steps 

will MDUF A IV take to further improve the pre-submission process? 

The Honorable G. K. Butterfield 

I. Can you discuss the current process for FDA inspections of medical device 

manufacturers? 

2. Does FDA provide any sort of advance warning to manufacturers be lore inspections 

occur? 

3. Does FDA inspect all manufacturers with the same level of regularity and in the same 

manner? 

4. Does the MDUFA 4 agreement address any ofthe concerns the industry has related to 

inspections? 

5. What can be done to bring more predictability and transparency into the process?