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74–086 2012

MEDICAL DEVICES: ARE CURRENT REGULATIONS 

DOING ENOUGH FOR PATIENTS? 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

FIRST SESSION 

JUNE 18, 2009 

Serial No. 111–52 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

(II) 


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(III) 

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JAN SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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C O N T E N T S 

Page 

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

New Jersey, opening statement .......................................................................... 1 

Hon. Nathan Deal, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 3 

Hon. Lois Capps, a Representative in Congress from the State of California, 

opening statement ................................................................................................ 3 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 3 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 4 

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

Texas, opening statement .................................................................................... 6 

Hon. Donna M. Christensen, a Representative in Congress from the Virgin 

Islands, opening statement ................................................................................. 7 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 8 

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

opening statement ................................................................................................ 9 

Hon. John P. Sarbanes, a Representative in Congress from the State of 

Maryland, opening statement ............................................................................. 10 

Hon. Kathy Castor, a Representative in Congress from the State of Florida, 

opening statement ................................................................................................ 11 

Hon. Bruce L. Braley, a Representative in Congress from the State of Iowa, 

opening statement ................................................................................................ 11 

Prepared statement .......................................................................................... 14 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, prepared statement .................................................................................. 92 

WITNESSES

Marcia Crosse, Director of Health Care, Government Accountability Office ..... 17 

Prepared statement .......................................................................................... 20 

Answers to submitted questions ...................................................................... 93 

William H. Maisel, M.D., Ph.D., Director, Medical Device Safety Institute, 

Department of Medicine At Beth Israel Deaconess Medical Center ................ 42 

Prepared statement .......................................................................................... 44 

Phillip J. Phillips, M.D., MPH., Independent Consultant .................................... 52 

Prepared statement .......................................................................................... 55 

Answers to submitted questions ...................................................................... 95 

Peter Lurie, M.D., M.P.H., Deputy Director, Health Research Group, Public 

Citizen ................................................................................................................... 58 

Prepared statement .......................................................................................... 62 

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

1Mr. Lurie did not respond to submitted questions for the record. 


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(1) 

MEDICAL DEVICES: ARE CURRENT REGULATIONS DOING ENOUGH FOR PATIENTS? 

THURSDAY, JUNE 18, 2009 

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

The subcommittee met, pursuant to call, at 9:30 a.m., in Room 

2322 of the Rayburn House Office Building, Hon. Frank Pallone Jr. 

[Chairman of the Subcommittee] presiding. 

Members present: Representatives Pallone, Dingell, Green, 

Capps, Matheson, Barrow, Christensen, Castor, Sarbanes, Murphy, 

Space, Braley, Deal, Buyer, Pitts, Burgess, and Gingrey. 

Staff present: Steve Cha, Professional Staff Member; Sarah 

Despres, Counsel; Elana Leventhal, Policy Advisor; Karen Nelson, 

Staff Director for Health; Alvin Banks, Special Assistant; Caren 

Auchman, Communications Associate; Karen Lightfoot, Communications Director; Clay Alspach, Counsel; and Chad Grant, Legislative Analyst. 

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

Mr. PALLONE. The subcommittee is called to order, and I will recognize myself initially for an opening statement. Today’s subcommittee is meeting to discuss the FDA’s regulation of and authorities over medical devices. The goal of today’s hearing is to determine if the current regulations are doing enough for patients 

while ensuring that these very important and sometimes life-saving devices are truly safe and effective. 

We are here to hear about where the current system works well 

and where shortfalls might be. There is evidence of an approval 

system that is broken, that its standards, its procedures and its 

rules don’t meet modern needs of getting medical devices to those 

in need with confidence in their safety. 

We have made huge advances in medicine over the last few decades. Many illnesses that were once a death sentence are now preventable, curable or at least manageable through modern medical 

treatments. New and emerging technologies hold promises that our 

great-grandparents could never have imagined, and the medical device industry is one of the main drivers of this progress. 

From pacemakers to artificial hips to tongue depressors, we can’t 

enter the health care system without coming into contact with 

these devices. And we need an approval process that keeps pace 


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with new technologies, a modern process consistent with progress 

in medicine. We have to maintain the delicate balance between 

wanting to put these new technologies in the hands of patients who 

desperately need them and ensuring that the devices are actually 

safe for use in humans. 

Now, last month this subcommittee held a hearing on the issue 

of preemption in the wake of the Regal versus Metronix Supreme 

Court decision. The Supreme Court ruled that patients could not 

receive compensation for their injuries, medical expenses, and lost 

wages caused by defective, pre-market approval or PMA devices or 

inadequate safety warnings. 

While state product liability provides incentives for companies to 

make safe products, it should not be the only tool we have to ensure that the medical devices that are on the market today are 

safe. We need to know that the approval process and the regulatory 

standards are strong and enforceable and that the agency is empowered with the ability to ensure the safety of these products. 

It is for this reason that we are here today at this hearing on 

the medical device approval process. I want a comprehensive overview of the major issues and potential problems that may arise in 

the regulation of medical devices. Of greatest importance to me is 

to find out what the FDA needs to ensure that the medical devices 

on the market are safe and effective. 

In the FDA Amendment Act of 2007, I requested a GAO study 

to look specially at the 510(k) process and in particular focus on 

the pre-amendment devices that have never been through the FDA 

approval process. 

The GAO is here today and will talk about that report in more 

detail. And I am interested to hear how the FDA is moving to review the high risk class three devices that have yet to ever be approved formally, as Congress instructed the FDA to do in the Safe 

Medical Device Act of 1990. 

Why is it taking so long for the FDA to act, and what is the consequence of this inaction? Are there devices being cleared onto the 

marketplace that shouldn’t be? 

But beyond this particular study, the GAO has written other reports on medical devices. These studies have highlighted some of 

the successes and possible failures in FDA’s ability to properly assess the safety and effectiveness of devices as well as maintain sufficient post-market surveillance and controls to ensure the devices 

patients are using continue to work the way they are supposed to. 

And I am looking forward to hearing more about these findings 

as well. I also look forward to other witness testimony and hope 

that they give our committee members an in-depth look into how 

the process is working and where it may need to be fixed either 

through legislation or through increased and enhanced oversight at 

the FDA. At the end of the day, we are all talking about real people here, patients who need to know that these devices will do what 

they say, that they are supposed to do, and they won’t cause them 

avoidable harm. 

I want to thank particularly Dr. Marcia Crosse from the GAO 

and her team’s tireless efforts to ensure that we are responding to 

the needs of patients. And now I would recognize Mr. Deal, our 

ranking member, for an opening statement. 


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OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. DEAL. Thank you, Chairman Pallone. Thanks to our witnesses for being here today. Since we have several of you, I will not 

take too much time in my opening statement but simply to reiterate that all of us, I think, share a concern that in this area of 

medical devices that they be safe and that they do what they are 

supposed to do and that the approval process is adequate and that 

the approval process is not unduly delayed. So there is a delicate 

balance that has to be reached in terms of the approvals. 

I am especially concerned in light of what this committee has 

placed on the FDA in recent weeks from tobacco regulation to yesterday an enhanced food safety bill. All of us understand the importance of all of these areas and support it. But I think one of the 

critical questions that always has to be asked is are we giving the 

FDA the resources and the abilities, legislatively or otherwise, to 

do what we are asking them to do. 

Each of you share an insight into those questions, and I look forward to your testimony and I yield back my time. Thank you. 

Mr. PALLONE. Thank you, Mr. Deal. Next is our subcommittee 

vice chair, Ms. Capps, from California. 

OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Ms. CAPPS. Thank you, Chairman Pallone, and we have great 

witnesses here so I will be brief as well. But I am very pleased and 

I want to note that we are holding this very important hearing 

today. 

I believe that members of Congress do have a duly to evaluate 

and reevaluate regulations to make sure that we are doing all we 

can to get safe and effective medical devices to American patients. 

However, safety and effectiveness are not the only things we need 

to keep in mind as we consider these regulations. 

We must also ask do the rules in place pose any barriers to technological innovation, barriers that might hamper the improvement 

of prevention, diagnosis, and treatment of disease. Ultimately our 

evaluation must include assessing the pre-market and post-market 

processes for safety and effectiveness as well. 

And I am glad that our committee takes seriously our role in the 

oversight on that process. I am eager to hear recommendations 

from our witnesses on what works, what doesn’t, and how we can 

adequately address both. I yield back. 

Mr. PALLONE. Thank you. The gentleman from Indiana, Mr. 

Buyer. 

Mr. BUYER. I reserve my time. 

Mr. PALLONE. Gentleman from Georgia, Mr. Barrow. 

Mr. BARROW. I waive. 

Mr. PALLONE. Gentleman from Pennsylvania, Mr. Pitts. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Mr. PITTS. Thank you, Mr. Chairman. Thank you for convening 

this hearing. More than 8,000 new medical devices come to market 


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in the U.S. each year ranging for syringes and surgical gloves to 

pacemakers and heart valves. 

The medical device amendments of 1976 gave FDA the responsibility of ensuring that medical devices are safe and effective and 

provided a risk-based framework for FDA to evaluate the wide variety of devices seeking approval. 

The majority of class two or moderate risk medical devices come 

to market through pre-market notification, also known as the 

510(k) process. 510(k) submission must demonstrate that the new 

device is substantially equivalent to one or more similar devices legally marketed in the U.S. And this excludes pre-1976 grandfathered medical devices. 

And the new device cannot be found substantially equivalent to 

a device that has been deemed misbranded or adulterated or removed from the market. To be substantially equivalent, the product 

must be at least as safe and effective as the legally marketed or 

predicate device, must have the same intended use and technological characteristics as the predicate, or if the intended use is the 

same but the technological characteristics differ, the technical differences must be shown to raise no new questions of safety and effectiveness. 

510(k) submissions must include descriptive data or specifications, performance testing, and in approximately 10 percent of 

cases, clinical data. The 510(k) process has evolved over the last 30 

years and has served the American public well. It provided FDA 

the discretion and flexibility to apply the proper amount of oversight to each device submission. It provides for timely product review, and it encourages technological innovation and evolution of 

device technology. 

GAO released a report in January of this year. It said ‘‘shortcomings in FDA’s pre-market review, post-market surveillance, and 

inspections of device manufacturing establishments’’ and I anticipate that Ms. Crosse will have more to say on the matter. But I 

believe the criticisms outlined in the report have more to do with 

FDA’s actions and inactions its lack of resources than the statutory 

approval process for medical devices itself. 

I look forward to hearing from the witnesses, and thank you. And 

yield back my time. 

Mr. PALLONE. Thank you, Mr. Pitts. Chairman Dingell. 

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. DINGELL. Mr. Chairman, good morning. Thank you for holding this hearing on the current state of medical device regulation. 

I want to thank today’s witnesses and look forward to their informative testimony. I also want to thank you for yesterday’s work and 

my colleagues on the committee for what we did with regard to 

Food and Drug in the area of foods. This is a worthy successor for 

that undertaking, and I am delighted to see the way that you are 

leading on this matter. It is very important that we address the 

concerns that are developing with regard to the balance of the responsibilities at Food and Drug on pharmaceuticals, cosmetics, and 

devices. 


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In response to the question that you propose in the title of this 

hearing, I am convinced that more could be done to protect patients. This year alone, there have been nine class one recalls of 

medical devices. It is to be noted that these recalls are occurring 

in a very badly staffed, indeed understaffed, agency without the resources to properly monitor its responsibilities. 

Class one recalls, as we know, are the most serious type of recall. 

It involves situations in which there is a reasonable probability 

that use of these products will cause serious injury or death. 

I would note that the device industry is a responsible institution 

and is composed of responsible people. And I know they will want 

to work with us to make progress in terms of assuring safety of the 

American consumers and the competition in that particular portion 

of the medical services industry and is conducted in a way which 

does not constitute a race to the bottom. 

Examining the regulatory framework that we currently confront 

for medical device approval, a few questions come to mind. First, 

is the current medical device approval standard ‘‘reasonable assurance of safety and effectiveness’’ rigorous enough? Second, does 

FDA rely on quality clinical studies during the medical device approval process? Third, is the current 510(k) review able to adequate 

ensure that devices that are marketed through this abbreviated approval process are safe and are being handled in a way consistent 

with the public interest? Last, is there too much discretion allowed 

to FDA in determining whether, through the 510(k) process, new 

device has the ‘‘safe intended use’’ or whether it has different technological characteristics? 

This is a matter of no small importance. FDA premarkets notification process for medical devices has been in place since 1976. 

Low-risk and moderate-risk devices are subject to abbreviated 

510(k) process. With some exceptions, high-risk devices require premarket approval, PMA, process. Devices that were on the market 

prior to the Medical Device Amendments, MDA, were allowed to remain on the market with the assumption that FDA would later determine the product’s safety. We need to know whether this has 

been done, and I don’t think anybody can answer that question at 

this particular time. 

Unfortunately, it appears that many of these products did not 

undergo rigorous review mechanisms, and unfortunately, we have 

other devices coming on the market using pre-MDA devices as a 

reference device. That is something that imposes substantial risk 

and peril on American consumers. 

I also have concerns with the frequency of inspection of medical 

device establishments, and this is something we ought to listen to 

carefully. GAO estimated that FDA inspects foreign manufacturers 

of modest-risk devices only once every 27 years. And foreign highrisk manufacturers every six years despite the fact that there are 

more registered device manufacturers in China than any other foreign countries. 

Chinese firms—listen to this—can expect FDA to visit them only 

once every 50 years. I don’t think anyone in this room can find that 

to be acceptable. 

Yesterday, we were pleased that this committee unanimously 

passed the Food Safety Enhancement Act in a bipartisan fashion, 


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which will give FDA greater authorities and resources to protect 

our food supply. I intend to build on this bipartisan success as we 

turn our next focus to medical devices and pharmaceuticals. As you 

know, we worked on this matter in a bipartisan way, and we 

worked cooperatively with the industry. And I call on all of my colleagues to show the same extraordinary cooperation they did while 

we worked on this legislation and also on the industry to understand that we seek to see to it that they prosper but at the same 

time that the consumers are protected. We hope we will have their 

help. 

Mr. Chairman, the FDA Globalization Act of 2009, legislation 

that you and I introduced earlier this year, will provide a solid 

foundation as we move forward to addressing the safety of medical 

devices and I will add also safety of pharmaceuticals and cosmetics. 

I want to thank the witnesses for joining us today as we take a 

close look at this important topic. I want to thank you, Mr. Chairman, and I want to thank my colleagues for the good work we did 

yesterday. And I want you to know I look forward to working with 

all of you to try and see to it that we carry forward for the protection of the American consumers on the balance of Food and Drug’s 

rather shabbily handled and rather under-financed resources and 

efforts. Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you, Chairman Dingell, and thank you for 

all you have done on this issue and others. Next is the gentleman 

from Texas, Mr. Burgess. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Thank you, Mr. Chairman. It is my firm opinion 

that this hearing should be about science and solutions, so I would 

just simply ask the question where is the Food and Drug Administration today? The Food and Drug Administration regulates more 

than 100,000 different medical devices manufactured by more than 

15,000 companies. This number represents a spectrum of devices 

from all three medical device regulatory classes as defined by the 

Medical Device Amendments of 1976. 

As often as I complain about how many times the Food and Drug 

Administration appears before the Energy and Commerce Committee, and it is no small investment of their funds that when we 

bring them up here. My complaint is aimed at wasting the Food 

and Drug Administration’s resources to continue answering questions about competence when it is clear that resources are the real 

remedy. 

If we are going to gavel in a hearing merely looking for a solution 

to any real or perceived gaps in the medical device approval process, then clearly I think we need to hear from the commissioner of 

the Food and Drug Administration or their surrogate so they can 

inform us what tools they need to address any gaps in regulatory 

authority to continue to ensure the safety of medical devices for all 

Americans. 

When informed of the use and possible misuse of the 510(k) process, the previous commission of the Food and Drug Administration, 

Dr. Andrew Von Eshenbach, dramatically stated that the 510(k) 

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proved with the change of administration, or are there still lingering issues? That is why we should have the presence of the Food 

and Drug Administration here today. 

I am also noticing a troubling trend in our conversation about 

both devices and drugs. Last year, we held a hearing on 

biosimilars. And did we have the Food and Drug Administration 

present? No, we had the Federal Trade Commission. Now, I would 

like to think that is merely an oversight, but a pattern does seem 

to be developing which I think we should stop. 

The Food and Drug Administration is not immune from interference. In the 1990s, it was noted the Food and Drug Administration took too long to approve devices, and we may have the opposite situation now. And none of us must forget that speed sometimes kills. The evidence points to the problem lying in the exceptions process to the device approval, known as the 510(k) application, which the Food and Drug Administration will grant for those 

devices which have substantial equivalents on the market. We 

want ingenuity and creativity in the marketplace, and we don’t 

want the government to stand in the way of that process. But safety must always be our foremost concern. If safety is compromised, 

patients will never seek out the treatment which these devices— 

and I will tell you as a practicing physician for over 25 years, in 

today’s medical legal climate, no doctor wants to place or implant 

a device which would be less than safe. 

This is why the premarket approval process, as lengthy and arduous as it is, should not be overturned simply because the process 

is long. Safety cannot be timed. The device approval process is long 

for a reason. The science must rise to the level of trust Americans 

place in the stamp which says approved by the Food and Drug Administration. 

There are questions that need to be answered, Mr. Chairman, 

which only the Food and Drug Administration can answer, and I 

hope we will take careful consideration of what the Food and Drug 

Administration has to say before we enact any laws or make 

changes to current authority. I will yield back the balance of my 

time. 

Mr. PALLONE. Thank you. Next is the gentlewoman from the Virgin Islands, Ms. Christensen. 

OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A 

REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS 

Ms. CHRISTENSEN. Thank you, Mr. Chairman. The approval process for medical devices is an important issue, and I thank you, 

Chairman Pallone, for holding this follow up hearing on it. 

Any concerns with the approval process, application process 

needs to be resolved so that we can continue to bring these lifesaving products quickly and safely to the American public. 

In the practice of medicine, we are always taught to weigh the 

benefits of treatment versus the risk, and while this is true for devices as well as for pharmaceuticals, the approach to approval, both 

in the primary product and the secondary one, trying to use the 

pharmaceutical model for medical devices is perhaps worse than 

comparing apples to oranges and, in my opinion, should be avoided. 


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I also think it is important to recognize that we are having this 

hearing as we are emerging from the previous administration and 

that today we are in a different administration, a different place, 

a different mindset, a different vision. Between 2001 and 2009, we 

watched scientists and sound science be replaced or significantly 

influenced by industry special interests and political and even religious ideologues on several scientific panels. And it is my sense 

that from previous hearings and the examples raised in testimony 

that the problem has not been so much the use of the 510(k) application process but the failure to adhere to the process and the dictates of sound science. 

Also from what I have read thus far, what I have seen is that 

there is a backlog in the work that FDA is already authorized and 

required to do. I am sure that does have something to do with prior 

staffing and funding levels. There may be some minor fixing of the 

medical device approval process that needs to be done, but for the 

most part, it seems sound. And if we adhere to science and use 

what is already provided for in the process, I think we will successfully protect the public’s health and safety. I look forward to the 

testimony and dialogue with our panelists. Thank you. I yield back. 

Mr. PALLONE. Thank you. Gentleman from Georgia, Mr. Gingrey. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Thank you, Mr. Chairman. Today as a result of advances in medical technology, we Americans enjoy access to a quality of health care that most nations do not. While some countries 

restrict or ration the types or amounts of drugs and devices that 

patients can access, American patients can receive the latest, the 

most advanced medical technology, such as an artificial hip or a 

knee or the latest cancer medication that will drastically improve 

and extend their lives. My 91-year-old mother, for example, recently had knee replacement surgery, and her quality of life has 

been dramatically improved over the last several months because 

of this surgery. 

Mr. Chairman, ensuring the safety of medical devices is an absolute necessity for our continued access to quality health care. The 

FDA is charged with making certain that all medical devices have 

been thoroughly tested for safety and effectiveness before coming to 

the market. It is one of the FDA’s primary responsibilities, and I 

support increased efforts in this area. 

Unfortunately, there is an inherent risk associated with most 

modern medical procedures regardless of advances in technology or 

indeed effective oversight. It goes without saying that there are few 

absolutes in this world. Mr. Chairman, I am especially concerned 

with the GAO report submitted for testimony today, the report citing an FDA report in 2006 that cites ‘‘the agency’s ability to understand the risks related to the use of medical devices is limited by 

the fact that the volume of submitted reports exceeded the FDA’s 

ability to consistently enter or review the reports in a routine manner.’’ 

We have spent a few months in this committee examining ways 

to expand FDA’s oversight of tobacco, a product that is, by all accounts, outside of the agency’s core mission or it was. This new auVerDate Mar 15 2010 00:54 Aug 11, 2012 Jkt 074086 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 E:\HR\OC\A086.XXX A086

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thority will further burden an agency that, by GAO standards, has 

had shortcomings in other areas of its current oversight responsibilities. 

With this thought in mind, I will look forward, of course, to hearing the testimonies of our witnesses today. Mr. Chairman, I thank 

you for calling the hearing. And with that, I will yield back my 

time. 

Mr. PALLONE. Thank you, Mr. Gingrey. Gentleman from Ohio, 

Mr. Space. 

Mr. SPACE. Thank you, Mr. Chairman. Very briefly, I appreciate 

you calling this hearing on what is obviously a very important 

issue, the safety of medical devices available on the market. I look 

forward to working with the committee as we continue to enhance 

a system that ensures that our consumers are safe while creating 

avenues for innovation and avenues to help consumers with their 

illnesses and afflictions and to strike that proper balance. I look 

forward to the testimony, and once again, thank you and Chairman 

Dingell for your work on this issue. 

Mr. PALLONE. Thank you. Gentleman from Connecticut, Mr. 

Murphy. 

Mr. MURPHY. Thank you, Mr. Chairman. I am looking forward to 

today’s hearing as a new member of this subcommittee. In particular, I am looking forward to getting a better understanding particularly from our friends at the GAO, what they found as it relates 

to the FDA’s current authorities to regulate varying classes of devices. Importantly, I believe we must determine whether the current processes that FDA uses, the 510(k) process and the PMA 

process, are adequate in their design but have been flawed in how 

aggressively the FDA uses its authority, or if the processes themselves need to be updated. 

Often what Congress has found in a number of areas is that the 

regulations we intend and pass are only as good as the regulators 

and the agencies that are meant to enforce them. With a new administration in office, I believe that it is going forward to hear from 

them directly about their intentions as it relates to these processes 

and how they intend, if at all, to enforce current regulations differently than their predecessors. 

Again, Mr. Chairman, I thank you very much for convening this 

hearing which is fundamentally about patient safety and improving 

our response to that but also about sustaining important advances 

in medical technology. I yield back the balance of my time. 

Mr. PALLONE. Thank you. Gentleman from Texas, Mr. Green, is 

recognized for an opening statement. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Mr. Chairman, I want to thank you for holding the 

hearing on the regulation of medical device safety. In 1976, the 

FDA was given the authority to regulate medical devices by Congress. Congress directed the FDA to characterize the devices into 

three categories: class one, class two, and class three. In order for 

a manufacturer to market a device for sale and use, it must demonstrate to the FDA the device is safe and effective for its intended 

use. 


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The manufacturers can do this in a premarket application process or a process which is known as 510(k) clearance processes. 

510(k) clearance is used to bring devices marketed that are substantially equivalent to a previous device that the FDA has already 

cleared for marketing. The premarket application process is more 

stringent than the 510(k) process. The premarket application can 

require clinical trials to demonstrate the safety of the device. 

Much has been said by this committee over the past year with 

regard to safety and monitoring of our food and drug systems at 

the FDA. I could argue that the device section of FDA has a good 

system in place to monitor the safety of medical devices compared 

to food and drugs. This is one of the few sectors the FDA has the 

ability to issue mandatory recalls in the instance of an adverse 

event, and they can require the reporting of adverse events by hospitals, nursing homes, and clinical labs. 

Additionally, the FDA requires manufacturers to identify and 

monitor significant adverse events in the manufacture and user facility device experience database. I am looking forward to hearing 

from the witnesses today on the current state of the medical device 

safety at the FDA. 

I would also like to say we have a new FDA commissioner, and 

I am sure the new team at the FDA will be making some changes 

in all sectors of the FDA. I would think we could identify the issues 

in this hearing today that need to be addressed, and I hope this 

new team will certainly consider it. And again thank you for the 

hearing. I yield back my time. 

Mr. PALLONE. Thank you, Mr. Green. Gentleman from Maryland, 

Mr. Sarbanes. 

OPENING STATEMENT OF HON. JOHN P. SARBANES, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MARYLAND 

Mr. SARBANES. Thank you, Mr. Chairman. I am looking forward 

to the testimony here today from the panel. This is another hearing 

that goes under the heading of the FDA is back or the FDA is coming back, however you want to look at it. 

We have had a number of hearings and markups of legislation 

designed to make sure that the FDA has the sufficient regulatory 

authority it needs to ensure that Americans have the confidence 

that these kinds of devices are safe and other things that are safe. 

That is essentially all the average person is looking for, that government is looking out for them in the way that they expect. 

I have been impressed, I guess is the word, maybe struck by discovering the things that the average person out there would assume are in place are not in place. So a lot of what we are doing 

is getting back to meeting the expectation of the consumer out 

there, that these protections are available. 

So this hearing, as others have done, is looking at whether there 

is, as I have said, the sufficient regulatory authority, whether the 

resources are in place at the FDA to do the job that they need to 

do, whether the talent is there. I believe that talent pool is becoming deeper and deeper by the day. And whether this attitude of vigilance that needs to be part of the agency’s approach is in place. 

So we are very encouraged by the direction things are moving, and 


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your testimony today will help shed even further light on that. And 

I yield back my time. 

Mr. PALLONE. Thank you. Gentlewoman from Florida, Ms. Castor. 

OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF FLORIDA 

Ms. CASTOR. Thank you, Mr. Chairman, very much for calling 

this important hearing on medical devices and the FDA. In reading 

the GAO report on the current status of the FDA regulation of 

medical devices, I am concerned about the efficacy of the practices 

used to approve devices, particularly those that may impose life-ordeath consequences on the patients that use them. 

I am also concerned that the FDA has thus far been unable to 

implement the more stringent premarket review of certain devices 

as intended by the 1976 law. FDA has not been able to review all 

of the reports of adverse events caused by devices released into the 

market, and this lack of oversight in the market poses a heightened risk for consumers. 

Now Americans certainly appreciate the lifesaving medical devices and the great innovations over the past decades. But with 

these innovations, we have seen many more advance products entering the market that require scrutiny and attention. And while 

we want to ensure that product review is completed in a timely 

manner, we do not want to allow under-reviewed devices into the 

market that may impose risks that could be avoided with a more 

responsible review. 

Thank you to the witnesses for being here today. I look forward 

to your testimony and recommendations. I yield back. 

Mr. PALLONE. Thank you. The gentleman from Iowa, Mr. Braley. 

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF IOWA 

Mr. BRALEY. Thank you, Mr. Chairman, for holding this hearing 

on medical device regulations. The safety of American patients is 

a matter of utmost importance to me and every member of this 

committee, and the issue before us today is truly a matter of life 

and death. 

The January 2009 GAO study of the 510(k) premarket notification process was eye-opening to say the least. As many here are 

aware, the report made the recommendation that the FDA expeditiously take steps to issue regulations for class three device types 

currently allowed to enter the market through the 510(k) process 

by requiring premarket approval or reclassifying them to a lower 

class. 

It is astonishing to me that the 94th Congress envisioned that 

the FDA would approve class three devices through the PMA process, and here we sit in the 111th Congress wondering why this 

hasn’t happened. Since the GAO report, FDA did take the step of 

requesting information on the safety and effectiveness of these devices. However, there are few details available and no timeframe 

that I am aware of outlining FDA’s next steps to help ensure the 

safety of those devices. 


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In addition, it is my understanding that the FDA has struggled 

with its postmarket surveillance of devices, and it is not meeting 

statutory requirements for inspecting certain manufacturers. This 

is not a good record of oversight of medical devices by the FDA. 

Amazingly, despite the limitations on FDA’s ability to keep Americans safe, we have seen other efforts here in Washington undermine the only other check on the safety of medical devices: judicial 

recourse for injured patients. For decades Congress has recognized 

the importance of keeping American patients safe by maintaining 

complementary systems to protect consumers through the FDA and 

American courts. 

Those who oppose ensuring patient safety through judicial accountability often make the argument that the FDA approval— 

Mr. PALLONE. I am just afraid that your mike is not on. What 

is going on? Did you press a button? 

Mr. BRALEY. I did. 

Mr. PALLONE. It is not working. 

Mr. BRALEY. Is it on now? The light is lit. 

Mr. PALLONE. Does that mean you can’t record it or—you want 

to move to another—we don’t want you not to be recorded. 

Mr. BRALEY. Where would you like me to begin? 

Mr. PALLONE. Start there. 

Mr. BRALEY. You want me to start over? I apologize to everyone 

in the room for having to go through this again. 

Thank you, Mr. Chairman, for holding the hearing today on medical device regulations. 

Mr. PALLONE. You can just continue where you were. 

Mr. BRALEY. All right, I think where I was right at the time of 

the interruption was talking about the importance of maintaining 

our complementary system of accountability to protect consumers 

through both the FDA and American courts. 

Those who oppose ensuring patient safety through judicial accountability often make the argument that FDA approval of a medical device is enough to ensure the safety of the device, yet here 

we sit in a hearing about FDA shortcomings, and the evidence is 

clear that we should not be betting lives on the efficacy of the FDA. 

That is why, in addition to ensuring a stringent medical device 

approval process through the FDA, we must pass H.R. 1346, The 

Medical Device Safety Act. This legislation is needed to ensure that 

every American patient has the ability to hold manufacturers of defective medical devices accountable for injuries and deaths caused 

by unsafe products. 

And, yes, many of these unsafe products did receive FDA approval yet still resulted in recalls, injuries, and deaths. The Medical Device Safety Act clarifies the intention of Congress to keep 

American patients safe by maintaining our complementary systems 

to protect patients through the FDA and American courts. 

Many medical safety experts agree that patient safety is compromised when we allow the FDA to have the final say on device 

safety, and the examination today of the FDA’s shortcomings is 

only further evidence of this. Strong state laws are critical to maintaining accountability for device manufacturers, and allowing the 

FDA to preempt these state laws is a surefire way to place sales 

over safety and profits over people. 


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When it comes to patient safety, we must now lose sight of the 

fact that the single most important priority that all of us share is 

saving lives. So thank you, Mr. Chairman, for holding the hearing. 

I thank the witnesses, my colleagues, and the audience here today 

for recognizing the importance that this issue has on individual 

Americans’ health and safety. 

[The prepared statement of Mr. Braley follows:] 


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Mr. PALLONE. Thank you, and I would ask unanimous consent 

that Mr. Braley’s entire statement be included in the record. Without objection, so ordered. And I believe that concludes our opening 

statements by members of the subcommittee. So we will now turn 

to our witnesses, and I obviously want to welcome all of you. Let 

me introduce each of you. Starting on my left is Dr. Marcia Crosse, 

who is with the GAO. I don’t have your title. What is your title? 

Ms. CROSSE. Director of health care. 

Mr. PALLONE. Director of health care. Okay, thanks. And then we 

have Dr. William Maisel, who is director of the Medical Device 

Safety Institute, Department of Medicine at Beth Israel Deaconess 

Medical Center in Boston and also Harvard University, I believe. 

And then we have Phillip J. Phillips who is independent consultant 

and Dr. Peter Lurie who is deputy director of Health Research 

Group for Public Citizen. 

And what we do is we have five-minute opening statements, and 

I think you know that. They become part of the hearing record, and 

then we may give you some written questions afterwards, hopefully 

within 10 days after the hearing, that we would ask you to respond 

to as well. And I will start with Dr. Crosse. 

STATEMENTS OF MARCIA CROSSE, DIRECTOR OF HEALTH 

CARE, GOVERNMENT ACCOUNTABILITY OFFICE; WILLIAM H. 

MAISEL, M.D., PH.D., DIRECTOR, MEDICAL DEVICE SAFETY 

INSTITUTE, DEPARTMENT OF MEDICINE AT BETH ISRAEL 

DEACONESS MEDICAL CENTER; PHILLIP J. PHILLIPS, INDEPENDENT CONSULTANT; AND PETER LURIE, M.D., M.P.H., 

DEPUTY DIRECTOR, HEALTH RESEARCH GROUP, PUBLIC 

CITIZEN 

STATEMENT OF MARCIA CROSSE 

Ms. CROSSE. Mr. Chairman and members of the subcommittee, 

I am pleased to be here today as you consider issues related to the 

regulation of medical devices. Americans depend on FDA to provide 

assurance that medical devices sold in the United States are safe 

and effective. 

FDA’s responsibilities span premarket review of devices, 

postmarket surveillance, and inspections of manufacturing establishments. We have done work to examine aspects of all these 

areas and have identified a number of concerns and made recommendations for improvements. 

Earlier this year, GAO added FDA’s oversight of medical products including medical devices to its list of high-risk areas warranting attention by Congress and the executive branch. Today I 

will provide some general background and touch on the findings 

from a number of GAO reports. 

As you know, FDA classifies medical devices into three classes 

with class one including devices with low risk to patients, such as 

bandages, and class three, including devices with high risk such as 

pacemakers. About two-thirds of medical devices are exempt from 

any FDA premarket review. These are mostly low-risk class one devices and some class two devices. FDA does little to monitor these 

devices including rarely inspecting their manufacturing facilities. I 


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will focus my remarks on the remaining one-third of devices, which 

require greater regulation and oversight. 

Almost all of these devices, mostly class two, are reviewed by 

FDA through its premarket notification process known as the 

510(k) process. The remaining one percent of medical devices are 

class three devices that are subject to FDA’s premarket approval 

or PMA process. 

Medical device regulation follows a least burdensome approach. 

The 510(k) process is less stringent than the PMA process. For 

510(k) submissions, the manufacturer must demonstrate that the 

new device is substantially equivalent to a device legally on the 

market. Clinical data are generally not required, and substantial 

equivalents will normally be determined based on comparative device descriptions including performance data. 

For the more stringent PMA process, the manufacturer must 

supply evidence providing reasonable assurance that the device is 

safe and effective. Manufacturers typically submit clinical data for 

a PMA application, but FDA does not always require clinical data 

even for implantable devices. FDA may approve a class three device solely on the basis of engineering data. FDA clears or approves 

the vast majority of both 510(k) and PMA submissions. Some 90 

percent of the class one and class two 510(k) submissions are 

cleared for marketing, and roughly 80 percent of PMA applications 

for class three devices are approved by FDA. 

In January 2009, we reported on a key area of concern regarding 

FDA’s premarket reviews. When Congress established FDA’s premarket review system for medical devices in 1976, it envisioned 

that all class three devices would be subject to the more stringent 

PMA process. Nonetheless, we found that more than 30 years after 

Congress acted, FDA had still not completed the regulatory steps 

necessary to require PMA reviews for some two dozen types of class 

three devices, including certain hip joints and other implantable 

devices. 

In the five-year period we reviewed, almost one-quarter of the 

class three device submissions that were cleared went through the 

less stringent 510(k) process. We recommended that FDA move expeditiously to address this issue, and in response, in April 2009, 

FDA began the necessary steps. However, the agency has not specified a timeframe for how quickly it will act on these devices. 

The least burdensome approach relies on postmarket studies to 

identify problems. However, FDA also faces challenges in 

postmarket surveillance of medical devices. For example, the agency’s ability to understand the risks related to the use of medical devices is limited because the volume of adverse event reports submitted has exceeded FDA’s ability to consistently review the reports. 

We have also found shortcomings in FDA’s monitoring of manufacturers’ compliance with postmarket study and reporting requirements. 

Finally, we have found that FDA has not conducted required inspections of manufacturing establishments which are FDA’s primary means of assuring that the safety and effectiveness of devices 

are not jeopardized by poor manufacturing practices. In 2008, we 

reported that FDA has not inspected domestic establishments on 


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schedule, and inspections of foreign establishments greatly lagged 

domestic inspections. 

FDA has begun to take steps to address shortcomings related to 

inspections including opening foreign offices and hiring additional 

inspectors. However, FDA has stated that it will be several years 

before inspectors are sufficiently trained to conduct foreign inspections. 

Taken together, our work raises concerns about the current premarket and postmarket activities that are necessary for ensuring 

the safety and effectiveness of medical devices. Mr. Chairman, this 

concludes my prepared remarks. I would be happy to answer any 

questions that you or other members of the subcommittee may 

have. 

[The prepared statement of Ms. Crosse follows:] 


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Mr. PALLONE. Thank you, Dr. Crosse. Dr. Maisel. 

STATEMENT OF WILLIAM MAISEL 

Dr. MAISEL. Thank you. Chairman Pallone, Ranking Member 

Deal, distinguished members of the committee, my name is Dr. 

William Maisel. I am a practicing cardiologist at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School in Boston. I also direct the Medical Device 

Safety Institute, an industry-independent, non-profit organization 

dedicated to improving the safety of medical devices. I have served 

as a consultant to the FDA’s Center for Devices and Radiologic 

Health since 2003, and I have previously chaired the FDA’s 

postmarket and heart device advisory panels. 

Thank you for the opportunity today to speak about medical device regulation and to discuss areas where improvements can be 

made to the benefit of millions of Americans who utilize medical 

devices every day. 

Recently several high-profile device safety issues have raised concerns about the FDA’s ability to properly evaluate and monitor the 

safety and effectiveness of medical devices. FDA has been criticized 

for taking too long to identify medical device safety concerns and 

for failing to implement robust scientific standards for device clearance and approval. 

FDA device physicians and scientists have alleged serious wrongdoing at FDA, including the alteration and distortion of scientific 

and technological findings and conclusions. Unfortunately, these allegations divert attention from the many superb FDA engineers, 

physicians, scientists, and public servants who work tirelessly to 

ensure that only safe and effective medical devices reach the American public. 

We are fortunate to have the preeminent medical device regulatory system in the world. The U.S. Food and Drug Administration regulates more than 100,000 different medical devices manufactured by more than 15,000 companies. They annually receive 

several thousand applications for new and modified devices, and 

they are mandated by Congress to complete their premarket evaluations in a timely fashion. 

Unlike drugs, the medical device product life cycle from conception to obsolescence is short. While a drug may remain on the market essentially unaltered for decades, rapid technological device advances offer the potential to improve medical device performance, 

reduce patient suffering, improve health, and sometimes treat previously untreatable conditions. 

Unnecessarily slowing the device regulatory approval process 

would be akin to leaving medical device patients with an outdated 

antique telephone in an iPhone world. Nevertheless, it is evident 

that to best protect the health of American medical device users, 

the FDA must promote and enforce a higher scientific standard for 

device clearance and approval, particularly for higher risk devices 

whose abnormal performance is likely to have adverse effects on 

patient health. 

Unfortunately, due to the current FDA premarket evaluation 

process, unanswered questions regarding device safety and effectiveness often remain at the time of FDA clearance or approval. 


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This creates the potential for a large number of patients to be rapidly exposed to a newly approved product in the absence of longterm follow-up data. 

For example, close to 268,000 patients have been implanted with 

the Medtronic Sprint Fidelis implantable defibrillator lead before it 

was recalled in October 2007 after it was determined that the wire 

was prone to fracture. A fracture of the lead which connects the 

implantable defibrillator to the heart may result in serious health 

consequences including painful electrical shocks or death. 

Mr. Sidney Engler, a patient of mine, was one of the unfortunate 

people to receive this lead when he had an implantable defibrillator 

placed in February 2006. Mr. Engler is a decorated World War II 

veteran, having served in Europe from 1943 to 1945, and on the 

evening of August 14, 2008, while preparing to retire for the 

evening, the simple act of removing his shirt over his head caused 

his defective defibrillator lead to fracture. Mr. Engler suffered a 

cardiac arrest in front of his wife. He required CPR and received 

numerous unnecessary painful shocks from his defibrillator. Fortunately due to the prompt response of his local EMTs, Sidney survived. Despite a prolonged hospital stay and months of rehabilitation, he has still not fully recovered. 

The FDA approved the Medtronic Sprint Fidelis defibrillator 

lead, the one in Mr. Engler’s heart, as a PMA supplement in 2004 

on the basis of no human clinical data. The original Medtronic 

defibrillator lead PMA was submitted in 1992. More than 30 supplements had been submitted in the interim, and the Fidelis lead 

bears little resemblance to its original counterpart. 

In addition to a lack of human clinical performance data, the 

FDA failed to require a postmarket study to monitor the device’s 

performance. The result was the widespread distribution of a defective product to hundreds of thousands of patients. 

Medical devices have enriched and extended the lives of countless people. The safety and performance of medical devices must be 

improved, and the frequency of medical device malfunctions and 

adverse events must be reduced. Additional consumer safeguards 

are needed. By demanding more thorough scientific device evaluations, the FDA can reestablish consumer confidence and improve 

its ability to protect the public’s health. Thank you. 

[The prepared statement of Dr. Maisel follows:] 


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Mr. PALLONE. Thank you, Dr. Maisel. Mr. Phillips. 

STATEMENT OF PHILLIP J. PHILLIPS 

Mr. PHILLIPS. Mr. Chairman, Mr. Ranking Member, subcommittee members, thank you for the opportunity to share my 

testimony with the subcommittee today. For the record, I am here 

as an independent consultant. I am not representing any companies, trade associations, or any special interests, and I receive no 

compensation from any source connected with any related to my 

appearance today. 

As I understand it, I am here simply to express my views of FDA 

regulation of devices based upon my 28 years of experience dealing 

with the regulation of medical devices. 24 years of that was with 

the Food and Drug Administration, and since then, I have had four 

years with the private sector. 

Keep in mind it was just a mere 33 years ago that devices were 

not subject to the regulations that they are subject to today. There 

was no FDA premarket authorization 33 years ago. No premarket 

authorization, registration listing, GMP inspections, and there was 

very little postmarket surveillance or postmarket vigilance. 

The 94th Congress did actually a remarkable job in designing the 

Medical Device Amendments of 1976. They created a three-tiered 

classification system for medical devices where the level of FDA 

regulation is commensurate with the risks associated with the devices. The system appears complex, but from my vantage point, it 

is actually very simple. 

Under the 1976 authorities, the simplest of devices were placed 

into class one subject to general controls. General controls include 

prohibitions against adulteration, misbranding, good manufacturing practices, labeling, registration listing, and a few others. 

Devices that were of greater complexity were put into class two 

subject to, at that time, it was required to meet performance standards. The distinction between class two and class three devices was 

that the agency has confidence that they knew sufficiently enough 

about the technologies and the use to conclude that performance 

standards could be developed to assure safety and effectiveness. 

The most complicated devices or complex devices, the higher-risk 

devices, where they did not have the confidence that general controls and special controls would assure safety and effectiveness 

were to be placed into premarket approval where a device-by-device 

demonstration of safety and effectiveness would be required. 

Lastly, under the medical device authorities, Congress provided 

the agency the ability to adjust classification over time based upon 

the experience and knowledge gained from the use of medical devices. And that was through reclassification processes. 

Initially there were 16 expert advisory panels that looked at over 

1,600 generic types of devices. A generic type of device could include dozens of manufacturers and literally hundreds of individual 

models, not to mention components and accessories. The recommendations of these committees fueled the rule-making process 

and FDA-generated classification regulations for each and every 

one of these generic types of devices. Today I believe that there are 

over 1,800 generic types of classification regulations in the Code of 

Federal Regulations. 


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The original framework exists; although, it has expanded to accommodate the diverse nature of medical technologies and also the 

rapidly advancing technology. 

What is a 510(k)? We have all talked about 510(k). It is a means 

for FDA to classify devices. It is not an approval. In fact, there is 

a prohibition for industry to refer to a clearance through a 510(k) 

as an approval of a device. The device is found substantially equivalent to go to market subject to the requirements that are associated with the generic class in which they are assigned. 

In 1981, I was a review scientist with FDA. I can remember my 

first 510(k)s. I looked at them. They were very simple submissions. 

We did side-by-side comparisons of descriptive data, one device 

versus an old device. It was actually very simple in the earlier 

days, but as technology evolved, we realized we had to have a 

greater framework and structure in which to render substantial 

equivalence determinations. 

Today’s 510(k)s are replete with performance data on the new devices. Simply examine any 510(k) or look at FDA guidance document, and you will see what FDA’s scientific expectations are for 

new devices. Reviewers get largely what they demand, and again, 

simply look at the number of additional information requests and 

look at the responses. You will find industry provides the reviewers 

exactly what they need in order to be able to support their clearances. 

The PMA process is very rigorous and demanding. It is not only 

high standards to get to market, but it is almost like a mortgage 

on a home. Once you are successful and you get your PMA application, it is actually a significant burden to stay on the market because of the filing of voluminous reports and supplements to the 

Food and Drugs Administration. 

It is sort of an interesting dichotomy that I will bring to your attention because innovations come from generally small entrepreneurial companies, and those are the least able to comply with the 

rigorous PMA requirements. With rare exception, only the large 

companies are able to play in the PMA arena. My bottom line is 

I think that there is a place for the PMA process, and it should be 

used whenever it is warranted. 

As far as my recommendations, I will leave you with just simply 

four. We have new administration at the Food and Drug Administration, and I think that we should empower Dr. Hamburg and Dr. 

Sharpstein to look at the medical device program, identify any gaps 

that exist and formulate a strategy for dealing with those gaps. 

The class three devices, I agree completely with the General Accounting Office. They need to be dealt with either through reclassification or premarket approval, one or the other. 

There is another interesting issue that I will bring to your attention, which I think is also a gap. It is a deficit in the way that devices are regulated. For class two devices, they were supposed to 

be performance standards. The agency has never promulgated performance standards, actually one dealing with the safety of leads 

associated with electrical products that come in contact with patients. But by and large, there are no performance standards, and 

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trols replaced performance standards with the Safe Medical Devices Act of 1990. 

I believe that the agency should develop special controls for everything that is in class three, just like there should be premarket 

approval for everything that is—excuse me. There should be special 

controls for everything in class two just like there should be premarket approval for every class three medical device. 

The last thing I will say is that the reclassification process needs 

to be vitalized, not revitalized because it has never been a really 

functional system. The agency and consumers need to have the 

ability to adjust the classification of devices based upon new information. With that, that is the end of my remarks, and I look forward to questions. 

[The prepared statement of Mr. Phillips follows:] 


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Mr. PALLONE. Thank you, Mr. Phillips. I want to hear from Dr. 

Lurie, and we will right now. But I did want to mention unfortunately that that bell was for 26 amendments that we will be—28 

amendments that we will be voting on. So we are going to hear 

from Dr. Lurie. Then we are going to go to the floor. It says right 

now that the first is 15 minutes, and each of them are five. I am 

hoping that when we get there, they will reduce it to two. But we 

are talking probably at least an hour and a half. 

So we are going to hear from Dr. Lurie and then we will go vote. 

Hopefully be back by around noon, maybe earlier. I doubt it. And 

then we will take questions. Dr. Lurie. 

STATEMENT OF PETER LURIE 

Dr. LURIE. Chairman Pallone, members of the committee, thank 

you for the opportunity to address you. Our comments this morning 

are primarily about the premarket review of medical devices and 

not about postmarket issues at all. 

I can summarize my comments as follows. The bad news is that 

device review, particularly with respect to effectiveness at the FDA 

is severely damaged. But the good news is that actions that the 

FDA could take today without any additional regulatory or statutory authority, in addition to the powers that could be granted by 

this committee and by the Congress, could make an enormous difference in improving the quality of medical device review. 

We are going to look at three separate problems in medical device review and give examples from recent regulatory proceedings 

to illustrate each of those. Problem one, the standard for approval 

of medical devices is lower than the standard of approval for drugs. 

By statute, the approval standards for devices is—for drugs, I am 

sorry—is ‘‘substantial evidence of effectiveness.’’ Whereas the sponsor of a new device need only demonstrate ‘‘a reasonable assurance 

of safety and effectiveness.’’ 

What this means is that whereas you might get two clinical 

trials for a drug to be approved, a single study, if you even get 

that, is the norm for devices. In fact, FDA regulations even permit 

the absence of well-controlled investigations under PMA. 

In practice for consumers what this means is that data that 

would never be considered sufficient to support the approval of a 

drug can result in the approval of a device and thus to treat the 

very same condition as my example will show, thus potentially diverting patients from effective and well-proven devices to less effective and less—excuse me—from diverting patients from effective 

and well-proven drugs to less effective and less well-proven devices. 

Consider the Cyberonic’s vagus nerve stimulator. It is a surgically implanted device for depression. A randomized control trial 

was done, and it failed to demonstrate any significant impact upon 

depression. However, the company was allowed to rely upon the 

kind of data that the drug division at the FDA would not even look 

at. They were allowed to look at follow-up data at a year using a 

control group that was not randomized. It was not blinded, using 

patients that were recruited at different times, and in which the 

patients were allowed to modify the antidepressant drugs and even 

get electroshock therapy. 


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An expert at the FDA’s drug center told the device center that 

with similar data for an antidepressant drug, that the drug center 

would not even have allowed the filing of an NDA. Yet instead 

what happened was the center for devices, the director consulted 

with more than 20 FDA scientists and officials, not one of whom 

recommended approval of the device. And he overruled all of them, 

and the product got approved. 

Fortunately, CMS has taken the position that the product is in 

fact not effective and is not reimbursing. So it has not been widely 

used. 

Now, the second two problems that I want to talk about deal 

with the 510(k). We have already heard a lot about them. We have 

heard already how, according to the GAO, the 510(k) process is 

generally less stringent, less expensive, and faster. We have heard 

how only a small minority of 510(k) submissions contain any clinical data. 

In fact the FDA says ‘‘it does not attempt to address all of the 

issues that would be answered in a PMA in its review of 510(k)s.’’ 

Now, the 510(k) pathway itself is not the problem. The problem is 

that there are two ways to get into the 510(k) process, and in practice, in part because of legislation and in part because of FDA practice, these are not interpreted in a rigorous way. And so products 

that ought to be going through PMA instead go through 510(k). 

So that leads to problem two, permissive interpretation of same 

intended use. That is one of the two elements that can get you into 

510(k). The best example here is ReGen’s Menaflex Collagen Scaffold, which is a device implanted during arthroscopic surgery to replace damaged knee cartilage. 

Now, after consulting with the FDA, ReGen began a trial to support a PMA, which was a well-done, two-year, randomized trial 

comparing partial meniscus removal to partial meniscus removal 

with the product, the MCS. Only problem was this study was stone 

cold negative. Absolutely no evidence of benefit whatsoever. 

Now, after the trial was complete, the FDA allowed the company 

to shift courses and submit a 510(k). Why were they able to do 

this? Because current agency practices provide for permissive interpretations of same intended use. They say ‘‘our scientific expertise 

enables us to exercise considerable discretion in construing intended uses.’’ 

Now, the first two 510(k)s were rejected, and in a third one, 

ReGen said that the predicate device, the device to which it needs 

to be shown to be substantially similar, were surgical meshes, surgical meshes that do not plainly seem to be for the same intended 

use at all. Rotator cuff mesh in the shoulder, anal fistula plug, and 

hernia repair graft. These don’t sound like devices that belong in 

the knee. 

In fact, an FDA reviewer pointed out that none of these meshes 

that the company had cited was implanted in a weight-bearing 

joint or intended to facilitate the regrowth of articular cartilage. So 

the result was these plainly dissimilar devices counted as ‘‘same intended use.’’ 

Of course, the company downplayed the results from the randomized control trial. It said that the bench testing data, like whether 

or not you could pull the cartilage replacement apart, or whether 


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it could hold sutures well, should provide the primary basis even 

though it had already done a well-done randomized control trial 

that showed that the product had no public health benefit whatsoever. 

And it made this point before an advisory committee saying that 

the decision for the advisory committee should be based upon the 

function of this device as a surgical mesh and not the ultimate clinical outcome. Let me tell you, as a doctor, this is really very painful 

even to think about. The clinical outcomes are ones that matter to 

us, and we hear Dr. Hamburg in particular talking about putting 

the agency on a public health footing, this is what, I think, she 

must be talking about. 

Subsequently a number of irregularities in the advisory committee review of this product came to light. It turned out that 

ReGen was permitted early input into the questions posed to the 

advisory committee, into who made the FDA presentation at the 

meeting, people who were not the original reviewers of the product, 

and even standing advisory committee members who were available to attend the meeting were replaced by clinicians thought 

more likely to favor the device. And all of the positive votes for this 

device came from the replacement advisory committee members. So 

there really were very large irregularities here. FDA is looking into 

this, and we hope that some of this will be explored further. 

The third problem which might get you into 501(k) if not properly enforced is different technological characteristics. The 1990 

amendments to the Food, Drug, and Cosmetic Act provide for products with different technological characteristics to be predicates as 

long as no new issues of safety or effectiveness are raised. 

The problem is that this has lead to predicates which are plainly 

different from the device up for approval, and thus products go 

through 501(k) when they should instead be going through PMA. 

The example here is transcranial magnetic stimulation, or TMS, 

also a device intended to treat depression. The agency permitted 

TMS to be reviewed under 501(k) with electroshock therapy as the 

predicate device, even though electroshock is toxic involves the administration of the electrical currents to produce a generalized seizure, whereas TMS simply applies a magnetic field to a specific region of the brain. 

They did a randomized control trial. The results showed that the 

effectiveness of this product was statistically nonsignificant and 

clinically minor. I am not going to get into the details here, but this 

product was eventually approved through a process called the de 

novo process, which is not the subject of my testimony today. But 

suffice it to say they couldn’t have got to de novo had they not got 

to 510(k). And they could not have got to 510(k) without invoking 

the different technological characteristics provision. So one thing 

leads to another, and now we have this device that barely works 

that is on the market. 

Let me conclude with two contextual matters and then the final 

conclusion. The two contextual matters are that the matter of the 

least burdensome means of showing effectiveness for devices that 

I believe Dr. Crosse referred to. 


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Mr. PALLONE. Mr. Lurie, I just want the members to know there 

is only about three minutes left. I want to hear the rest of it, but 

just so you know there is only three minutes left. 

Dr. LURIE. I will certainly finish well within that time. 

Mr. PALLONE. OK. 

Dr. LURIE. This gives the industry recourse to challenge many requests that it regards as onerous. Indeed, ReGen evoked this very 

language when the FDA was considering the unfavorable findings 

of its randomized trial. So that is the first contextual issue. 

The second is that in general the FDA has permitted scientific 

approaches that fall well short of rigorous, and we have listed a 

number of things just from the examples cited in this testimony are 

really unacceptable from a scientific point of view. 

Depending on the specific case, these lax scientific standards can 

be the result of any combination of the lower standard for device 

approval, the inappropriate routing of devices through 510(k) instead of PMA, the least burdensome requirement, or simply the 

lack of rigor at the agency level. 

Now, each of the issues that have been identified in this testimony can be remedied by a combination of agency practice, regulation, and legislation. And to the former, even today under existing 

authority, the agency can require greater scientific rigor. It can 

send more devices through the PMA, and it can tighten the same 

intended use requirements. 

But legislation could also make a difference. It could address all 

three of the problems that I focused on today: the lower approval 

standards for devices than for drugs, the permissive interpretation 

of same intended use, and the different technological characteristics loophole. We call on the Congress to pass exactly those three 

kinds of legislation. Thank you. 

[The prepared statement of Dr. Lurie follows:] 


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Mr. PALLONE. Thank you, Dr. Lurie. Now, as I said, we have 28 

votes, so I am going to say at least an hour and 15 minutes, you 

know. We will probably be back around 12:00, between 12:00 and 

12:30. I think you all said you could stay beyond that though. So 

we should be all right. Without further ado, the subcommittee is 

in recess. 

[Recess.] 

Mr. PALLONE. The subcommittee will reconvene. Let me apologize. We really thought we would be done by 12:00 or 12:30 at the 

latest, and obviously that is not the case. So I really appreciate the 

fact that the three of you stayed. I know that Dr. Lurie said he actually had to leave at 12:30 anyway, but I appreciate the fact that 

you stayed here all this time. 

The process, basically each of us, each member is allowed to ask 

you questions for five minutes. And then, as said, there may be 

written questions after particularly since what happened today, 

there will probably a lot of written questions. And you should get 

those within 10 days or so. 

So I am going to start by recognizing myself for five minutes. 

You know what we are trying to do obviously is see if there is a 

need for legislation to correct the concerns that many of you have 

raised about the medical device approval process. And that is how 

you could be most helpful to us if you have suggestions. There is, 

of course, a bill that Mr. Dingell mentioned. Part of his—well it is 

actually his and Bart Stupak and my bill and others, but, you 

know, we separated out the food safety, but we still have the medical device and the drugs and the other provisions. 

But that, in my mind, is more oriented towards inspections, lack 

of inspection, lack of resources. I don’t believe that it directly addresses whether we should change the procedure in terms of, you 

know, approval. I don’t think it relates to that. So that is kind of 

what I want to get answers from you on, and I guess my concern 

is that I don’t think the issue is whether or not we should have 

a 510(k) process, although if any of you feel we shouldn’t, you 

know, tell us. 

But I don’t think the issue is whether or not we should have it, 

but whether it is overly used and essentially abused, and whether 

or not this grandfathering, which was supposed to be essentially 

abolished, you know, or should be abolished and how long that 

should take or what the process should be to make sure that that 

is eliminated, if that is what you feel. 

And I guess I will start with Dr. Maisel, but I will ask any of 

you the same question. It sounds to me like the 510(k) process is 

appropriate for a product that has the same effect as products that 

are currently safely and effectively on the market, almost like a generic, which maybe I shouldn’t use. But I will use it because I kind 

of understand that. 

But if a product has a new effect or is used in a new way, then 

it is important to go through the more rigorous premarket approval 

process so that the patient can know that this new technology will 

actually work and work safely. 

So I guess what I am asking is is my analysis of that correct? 

And if that is true, is the problem that, you know, we have essentially extended this 510(k) process beyond products that are curVerDate Mar 15 2010 00:54 Aug 11, 2012 Jkt 074086 PO 00000 Frm 00081 Fmt 6633 Sfmt 6633 E:\HR\OC\A086.XXX A086

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rently safely and effectively on the market and the products that 

are going to be very similar to those, and that somehow we have 

gotten beyond that? And I am just asking that very generally. And 

I will start with Dr. Maisel. 

Dr. MAISEL. Well, I think you have it essentially correct. I think 

Congress actually did a pretty great job in forming a device law 

that correlates the risk of the device and the risk to the patient 

with the degree of rigor in which a product is reviewed. The problem with the 510(k), you do have it right. In order to be substantially equivalent, it needs to have the same intended use and the 

same technological characteristics, and if the technological characteristics are different, then it can’t—those changes can’t affect the 

safety and effectiveness. 

What happens is that there is a lot of latitude that the FDA has 

in making those decisions. There is a lot of latitude in making a 

decision about whether a device has the same intended uses we 

have heard this morning already, and there is no real good definition of what differences in technological characteristics should warrant the more thorough evaluation. 

There is a lot of reliance on bench testing, on testing in the laboratory of these products, which is fine except that there is no 

great correlation that that bench testing predicts clinical performance. And so there is this disconnect between the tests that are 

being done and how the product actually performs. 

The other loophole that I think is a big loophole that we haven’t 

really touched on is that companies can change their product and 

not file a 510(k) and not tell the FDA that they are marketing a 

different device. You do not have to file a 510(k) if a company 

changes a device and the company decides that there is no change 

in the safety and effectiveness of that device. Not the FDA. If the 

company decides that there is no change in safety and effectiveness 

and it is the same intended use, then they don’t even have to tell 

the FDA that they have modified their device. 

And there is a great example of this. The Edwards ET Logics 

valve was on the market for two and a half years. Many patients 

were implanted with it, and the FDA had no idea that it was even 

on the market. And finally they became aware it was on the market. They went to the company, and the company had followed 

FDA guidance that says if you change your device and there is no 

change in the safety and effectiveness, you don’t need to tell us 

about it. 

I mean that is a huge loophole that needs to be closed, and it is 

not that hard to close it. It requires legislation that says companies 

need to tell the FDA whenever they change a device and whenever 

they are marketing a modified 510(k) product, whether or not it affects safety and effectiveness. 

Mr. PALLONE. Now, I am going to ask the other two to respond 

to, although I know the time is almost up. But you have been waiting here for six hours, so I am not going to worry about the time 

much. But you basically feel that we should have a 510(k) process? 

None of you—well, I will ask the others, but you are not advocating 

we should not have it but that it is just overutilized. It is much 

too subjective. 


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Dr. MAISEL. I think it is overused, and it would have been interesting to ask Congress back in 1976, their vision of what percentage of products would have gone through the PMA process. I can’t 

imagine that they imagined only one percent of the devices would 

go through PMA process. 

Mr. PALLONE. All right, but now what about this grandfathering? 

I mean I get so confused because it seems to me that you could 

have a device that was pre-’74 I guess, whenever we first passed 

the approval act, and that is grandfathered. Then you use the 510 

to get approval for a device that is based on that grandfathered 

one, and then you can even use another device to grandfather, you 

know, to piggyback on the second one. So we have like, you know, 

generations—tell me if I am wrong—generations of devices that go 

back to this grandfather and never went through premarket approval. 

I mean how would you have us deal with that? 

Dr. MAISEL. I have to say that I would be interested in what Dr. 

Crosse has to say because she spent a lot of time obviously looking 

at the 510(k) program. I don’t view that as a huge problem right 

now. I think the bigger problem is the FDA’s assessment of the devices that are coming in front of them and the rigor with which 

they evaluate those devices, the level at which the bar is set for 

the evidence that the device is safe and effective. I don’t lose sleep 

over the grandfather issue. 

Mr. PALLONE. Okay. Well I will let the other two answer if you 

will, and then we will go to Lois, and we will see who else shows 

up. Go ahead, either one of you. Mr. Phillips? 

Mr. PHILLIPS. I think there should be a 510(k) process because 

I will tell you I think that it has served consumers very well 

throughout the years. And I think that if you look at the totality 

of all decisions, we are talking about over a quarter million devices 

that have been cleared through the 510(k) process since 1976. And 

I think by and large, the devices that have become controversial 

are actually very few. So I think that there is overwhelming evidence that the program is actually a very valuable program. 

Mr. Chairman, you asked a question about the grandfathering, 

and I appreciate Dr. Maisel’s answer to that because I really don’t 

think that it is a concern. All of those products that were grandfathered did go through an evaluation by experts both on independent advisory committees—and this is—in my testimony, I refer 

to 16 different expert advisory panels that reviewed all of these different types of devices. And they went through all of the different 

generic types. They looked at available information that was in the 

public domain at that time, which was published, peer-reviewed literature. 

And they also factored in their own expertise, and they made 

their recommendations to the agency regarding what classifications 

those products should be placed in. And I think that actually that 

process had a tremendous amount of integrity. 

As I said this morning, I think that part of the issues that we 

are all dealing with here or struggling with is the fact that in 1976 

Congress envisioned that all of these class two products would be 

the subject of performance standards. And the agency was not successful in developing performance standards because the process 


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was too resource-intensive. That was the agency’s explanation 

then, and I can tell you it is the explanation today. 

Congress did allow the agency to switch from performance standards to what is called special controls, which are very flexible 

means of trying to mitigate risks associated with devices. And it 

can include actually clinical testing. So when I made the recommendation this morning that serious consideration be given to 

developing special controls for all devices in class three, what I was 

looking at was the situation that I think all of the panelists were 

dealing with, and that is these isolated incidents or clearances 

where there is criticism about not having proper clinical data or 

having proper testing. 

I think there is a means under the existing statute to actually 

get all of those things in place for all of these problems at least as 

an opening measure before somebody thinks about opening the 

statute. 

Mr. PALLONE. Okay, thank you. Dr. Crosse, and thank you for all 

you have done with the GAO report and all. 

Ms. CROSSE. Certainly. You know we looked at this issue quite 

extensively, and I would have to agree that the 510(k) process in 

general seems to be working well and as intended. When we looked 

at the percentage of device applications—not applications, I am 

sorry. Under the 510(k) process, device submissions that came in, 

you know, 86 percent of them were judged as having both the same 

intended use and the same technology, and only 14 percent as having a different technology that needed to be evaluated for whether 

it posed any risk to the safety of the device. 

So the vast majority there are coming in as the same intended 

use and the same technological characteristics. I think the question 

is exactly what Dr. Maisel said, is the evidence of that that FDA 

is accepting adequate. Where we have had some problems in looking at FDA’s reviews of devices, both under PMAs and under the 

510(k)s is the kind of information that FDA is accepting as sufficient to make their determinations. 

And that is really something that we are not qualified in any individual case to question, to say no, really we have a different opinion about this technology. So we are not coming out and pointing 

to specific devices, but I think overall you do have a question about 

whether or not there is a greater need for clinical data in some instances and whether FDA is accepting that small companies can’t 

be expected to have the same level of clinical information as a large 

company would be expected to produce or that you can’t have the 

same kind of studies being conducted and that this is enough. 

You know so we have seen some evidence of that, but it is a 

small number of cases where we have seen that occurring. And so, 

you know, it is not a question of legislative authority. It is a question of the application of that in the scientific review. 

Mr. PALLONE. Okay, thank you. Our vice chair, gentleman from 

California, Ms. Capps. 

Ms. CAPPS. Thank you. Excuse me. I am going to try to avoid the 

questions that you have asked. Since it is just the two of us, we 

will try to see how much we can cover quickly. Thank you very 

much on my behalf as well for your patience with today’s proceedings. 


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I have two different topics to bring up. I will address the first 

one to Mr. Phillips, but I actually would love to get some comment 

from anyone who wants to on this topic, both of these topics. 

One, the 510(k) process is only one component of the regulatory 

controls composed on medical devices intended to ensure safety and 

efficacy. In fact, the U.S. medical device regulations have been 

models for regulatory processes developed in some other countries 

as well. Mr. Phillips, can you describe or does anyone want to describe other regulatory controls besides the 510(k) and their roles 

in protecting patients and health care professionals? 

And let me just ask the question, the second one on this topic. 

I know there are concerns about these different elements of the approval and regulatory process. Does anyone want to comment on 

how congressional efforts to give the FDA more funding and resources could help this 510(k) and other processes as well to improve and be more effective? 

Mr. PHILLIPS. Yes, ma’am. If you look at the controls that are 

available to the agency to ensure safety and effectiveness, they actually have a wide variety of different controls. Premarket notification is actually what is referred to as one of the general controls 

for medical devices. That is under the 1976 amendments. 

Other general controls include provisions against adulteration 

and misbranding. There are labeling requirements. There is registration listing, which basically identifies establishments so that 

they can do, the agency can do inspections. So GNP inspections 

would be part of the general controls. 

The same thing with some postmarket surveillance activities, for 

example, records and reports like medical device reporting. Those 

are referred to as the general controls, and they apply to all medical devices regardless of the class because they apply to class one, 

two, and three. 

It is interesting because premarket notification is a general control that applies to all products. But under the FDA Modernization 

Act of 1997, most class one devices were exempted from 510(k) review. In fact, the agency had the authority to reserve certain devices if they met what was called the reserved criteria. And there 

is probably 10 percent of the class one medical devices that still 

come in under 510(k). 

It is almost as if that action by Congress changed premarket notification or 510(k) from more than just a general control to a special control that would apply primarily to class two medical devices. 

I mean in reality that is what has really happened. 

It is also interesting because if you look at what the agency has 

under special controls as tools that can ensure safety and effectiveness, as I said in my morning testimony, they have a tremendous 

amount of controls that are available to them to apply to devices 

as they believe necessary from not just premarket notification but, 

you know, patient registries in a postmarket period. 

There can be clinical data that is required. There can be specialized labeling. There can be agency guidelines that are put into 

place. So there is a wide variety of different tools that can be applied. 

For the class two devices, it is difficult to describe how well those 

controls can ensure safety and effectiveness because by and large, 


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class two devices today are not subject to special controls. And that 

was sort of the problem that I pointed to this morning because I 

think that would be one of the first things that I would think of 

is that there could be more special controls, guidance documents, 

that looks at the risks that are associated with class two devices 

and figuring out what are the proper mitigation measures that address those risks. And again I think that the agency has really a 

wide variety of things that are available to them should they elect 

to apply those for the regulation of devices. 

As far as, you know, what efforts or funding could Congress ensure that the agency has? I am not an advocate for just simply increasing FDA’s budget by any specific amount or any specific percentage. I have heard of people saying well, the agency should have 

their budget doubled. I think that the agency should receive the 

funding that could allow them to take care of the priority issues 

that need to be taken care of. 

And clearly I think the two that come to my mind is inspections 

because clearly there is no question. The agency has to have more 

of a presence in facilities, whether it is class one, two, or three, 

than what they do today. That is one. 

I think in the postmarket area, I think again that is an area 

where there needs to be resources applied at the agency, not just 

necessarily in personnel with the analysts that can look at MDR 

reports or adverse events that are coming into the agency, but also 

to improve the infrastructure that they have in order to be able to 

process the reports that come in. I think as Marcia Crosse indicated in her testimony, it is a tremendous amount of data that is 

coming into the agency. And I really don’t think they are equipped 

to deal with that information as efficiently as what they really 

should. So I think that that is a big issue. 

In the premarket area, you know, we have already said that for 

the class threes, the agency has already moved out to take the very 

first steps to ensure that they get the class three devices subject 

to premarket approval. The steps that they have taken so far are 

the easy steps. The more difficult steps are assuming that the 

PMAs come in for all of these different products. The agency is 

going to have to be able to process those applications, and they are 

not going to be able to process them at existing staffing levels. So 

with that, I will close my answer. 

Ms. CAPPS. Okay, Mr. Chairman, do I have your permission to 

continue as though it was almost like a second round, or would you 

rather me stop? I have another question. 

Mr. PALLONE. No, I think you continue and then Mr. Burgess is 

here. And we will let him continue. Are you able to stay a few more 

minutes, Dr. Maisel? 

Dr. MAISEL. Yes, I am. 

Mr. PALLONE. Okay, go ahead. 

Ms. CAPPS. Thank you very much. Since it has been this long, 

I feel like maybe we want to have a little more robust conversation 

than we might have otherwise. In other words, I am interpreting 

what you are saying, and I want to see if anyone else wants to add 

to it, the 510(k) model, while a good one, isn’t offering—there might 

be some others like inspection and postmarkets that, if there were 

more resources, could also add to the robustness of the regulations 


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and the evaluation in achieving the goals. Would you like to comment? 

Ms. CROSSE. Well, yes, I would say in fact that the process requires the postmarket steps, and in fact, it is constructed to depend 

upon the postmarket steps. And that has been where the greatest 

problems have been with FDA’s resources and ability to attend to 

the kinds of adverse event reports that come in that let them know 

about problems that couldn’t necessarily be known in advance until 

they are out in widespread use. 

Ms. CAPPS. And you could make the correlation—I am not asking 

you to define it—between the amount of resources that, if you are 

limited you are going to put them into the 510(k). But if you had 

more, you would put more because inspections require more resources obviously. 

Ms. CROSSE. Well, it is that, and it is structured under the user 

fees that there is funding for the premarket steps. The user fees 

are paying for the premarket steps—— 

Ms. CAPPS. But not the postmarket. 

Ms. CROSSE [continuing]. But had not been, until very recently, 

available to pay for some of these postmarket steps. There is now 

additional funding for the inspections, and I would concur that that 

has been a great area of weakness and that they are now beginning 

to address. 

They are also beginning to address some of their IT infrastructure problems that have limited their ability to analyze some of the 

information that they have even when they have received it. And 

so I think that they are beginning to take steps, but I see particular weaknesses on the postmarket side. 

Ms. CAPPS. Okay, any—— 

Dr. MAISEL. May I respond to that? 

Ms. CAPPS. Yes, please. 

Dr. MAISEL. So I agree that certainly increased resources will undoubtedly help the FDA. I think it would be impossible to dispute 

that. And I agree that the postmarket area and areas like inspections will help. I think we would be naive to think that throwing 

money at the issue is going to solve the problem. 

Ms. CAPPS. I agree. 

Dr. MAISEL. And I am not saying you are implying that, but we 

could give the FDA unlimited resources. But if we don’t change 

their approach to evaluating products, if we don’t change the 

science-based evaluations, then we are still going to be faced with 

problems. 

Ms. CAPPS. I see. I will turn to another topic then with permission. You know it is interesting. Usually when we think of FDA, 

we think of safety. But effectiveness is just—we always say safety 

and effectiveness. And today we focused primarily on safety, but 

whether a device works or not is, I would submit, equally important. I am sure you agree. The history of Food and Drug and Cosmetic Act includes many instances where Congress has had to 

tighten regulations because the products being marketed weren’t 

living up to their goals and were, in fact, ineffective. 

Despite this history, we hear from some that we need to keep the 

barriers low even for potentially lifesaving devices to enter the 


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market. To do otherwise, these critics argue, could stifle innovation 

and keep patients from treatments that may heal them. 

But what concerns me is that if there is not enough study of the 

effectiveness of devices before they are marketed, patients and 

their doctors are forced to make decisions about whether or not to 

use the device that really may have never adequately been demonstrated to work. 

Mr. Maisel, maybe I will start with you this time. In this case, 

I will just use an example because I was a coauthor. I have been 

a school nurse, and so I know about external defibrillators. This 

panel has endorsed Ms. Sutton’s bill, the Josh Miller—and he was 

a student—Hearts Act in a bipartisan fashion because this bill 

would put lifesaving devices in every school. It is a big step. Don’t 

always think of schools as being a place where they are needed, but 

there is evidence that they have been. 

I do agree with that policy, but I also am very concerned particularly with not fully developed people that these devices work. Dr. 

Maisel, can you tell us about that particular situation with your experience? 

Dr. MAISEL. I think you have picked out a very important medical device, external defibrillators, which have been proven in wellconducted clinical studies to save lives. 

Ms. CAPPS. Yes. 

Dr. MAISEL. Sudden cardiac deaths claim about 330,000 lives 

each year in this country. It kills more people than AIDS and 

breast cancer combined. I mean it is a huge deal, and we are fortunate to have a good therapy. Now, interestingly the automatic external defibrillator is one of the class three 510(k) devices mentioned in the GAO report. 

And if you doubt that there is an issue with the 510(k) program, 

this is the poster child for the problem because since 1996, there 

have been 52 recalls affecting automatic external defibrillators. 

There has been over 300,000 AEDs that have been recalled. One 

in five AEDs out in distribution in this country have been recalled. 

Ms. CAPPS. Yet they were put out. 

Dr. MAISEL. They are put out, and the challenge of—I think it 

is unrealistic and impossible to think that every iteration of an external defibrillator is going to be clinically evaluated. I don’t think 

it should be, and I don’t think it can be. But we need to figure out 

a better way to evaluate these devices—— 

Ms. CAPPS. You have an idea? 

Dr. MAISEL [continuing]. Instead of approving them each time 

based on the fact that it is as good as the one that just came—— 

Ms. CAPPS. Right. 

Dr. MAISEL [continuing]. Down the line. I think another thing, 

another important point you made was the safety and effectiveness 

point. 

Ms. CAPPS. Right. 

Dr. MAISEL. It is impossible to assess safety without knowing the 

effectiveness. If I told you a medical device kills two percent of the 

people who get it and ask you is that safe or not, you can’t answer 

the question. Compared to what? You need to know, you know, 

maybe the disease is 100 percent fatal without the device and everyone lives who gets it. So two percent sounds great. Maybe no 


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one dies without the device and two percent die with it, and then 

it is terrible. You need to know effectiveness if you are going to 

evaluate safety. 

Ms. CAPPS. I will ask all three of you. Do you think we have adequate resources or methodology to do that? Maybe that is too harsh 

a question. What should we be doing in this area that we are not 

doing now? 

Ms. CROSSE. I am not certain that it is an issue of either resources or methodology. I mean it seems to me it is an application 

of current existing approaches or an ability perhaps in that particular instance for the agency to say, you know, you can only have 

so many iterations before you have to provide some other sort of 

information, which might be a different regulatory approach. But 

it is not clear that there is evidence to establish that. It is not 

something we have really directly looked at. 

Ms. CAPPS. Is it that there is not evidence to establish it or we 

have not asked those kind of questions? 

Ms. CROSSE. I think probably either. 

Ms. CAPPS. Is it in that area that we should push? 

Ms. CROSSE. We haven’t got anything that I would be able to give 

you an answer about how one might go about or what would be 

necessary. 

Ms. CAPPS. Well, let me just focus on the recalls of the AED. 

Those came, I imagine, because people had untoward effects or 

didn’t work when they were—— 

Dr. MAISEL. So the FDA and our country has a medical device 

reporting system, and so adverse events that manufacturers become aware of that cause harm to patients are required to be reported to the FDA. 

Ms. CAPPS. Right. 

Dr. MAISEL. And companies become aware of these things, and 

so since 1996, there have been approximately 370 deaths associated 

with failure of AEDs. And so in response to device failures that get 

reported, companies become aware of them and recall their product 

because they have defects, whether they are related to the circuitry 

in the device, battery function. These are complicated devices, and 

things happen to them. 

Ms. CAPPS. Are they recalled at the insistence of FDA? 

Dr. MAISEL. Virtually every recall of most devices are ‘‘voluntary’’ 

recalls by the manufacturer, meaning that the manufacturer becomes aware of a problem and then chooses to issue a voluntary 

recall, sometimes with the coercion or urging by the FDA. And 

there are rare occasions where the FDA will issue a recall if the 

company doesn’t. But most of them are voluntary. 

Ms. CAPPS. Is there anything within the Food and Drug Administration that has jurisdiction in this area, where, if there is a recall, 

that there is an action that is taken by the FDA? 

Ms. CROSSE. Well, FDA has the authority both to order a recall 

or certainly to evaluate the information, urge the company, alert 

them to the problems that they are seeing and the adverse event 

data if the company is not aware of it already. Usually the company would become aware of—— 

Ms. CAPPS. Right. 


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Ms. CROSSE [continuing]. Something first, but, you know, one 

could argue this is an example of the system working as it is designed that when adverse events are identified, recalls occur. I 

think the question then becomes what does FDA do with that information? If they see a pattern, what then feeds back into their evaluations of subsequent devices when those applications come in? 

And I can’t answer that question for AEDs. 

Dr. MAISEL. I would also say if I were designing the FDA in a 

postmarket surveillance system, I would want the FDA to be the 

one finding some of the problems. It is extremely rare that they are 

actually the ones that identify the postmarket problem despite the 

fact that they are asking for data. 

Almost always it is the clinical community that comes up with 

the problem or the manufacturer gets reports and identifies it and 

reports it to the FDA. It is very rare that the FDA combs their 

database and their reports and comes up with an a-ha moment 

where they have identified something. 

Ms. CAPPS. Well, Mr. Chairman, this is not a point I want to belabor, but it seems to me a point of perhaps interest of further discussion at another time. It appears to me that when something 

comes to light, when the public knows it, then something happens. 

But I am also mindful that you can’t always count on that to happen necessarily. But I will leave it at that, and thank you very 

much. 

Mr. PALLONE. Thank you. Thanks so much. Mr. Burgess. 

Mr. BURGESS. Thank you, Mr. Chairman. I thank the witnesses 

for bearing with us. I hope you were able to watch the drama on 

television in the House floor all day, spellbinding. I am sure you 

were on the edge of your seats through all of those reconsiderations. 

Dr. Crosse, on the 510(k) process we have been discussing, that 

is only one component of regulatory controls imposed on medical 

devices intended to secure their safety and efficacy. What other 

controls are there, and what, if any, are the GAO’s recommendations for the Food and Drug Administration to incorporate those if 

they haven’t already done so. 

Ms. CROSSE. Well, I think that the other key controls from our 

point of view are those postmarket controls, the ability of the agency to ask for further study, for additional data, for monitoring of 

the devices by the companies, and also the adverse event systems 

that FDA has. We have not pointed to legislative remedies being 

needed in this area. The kinds of problems that we have seen are 

ones that FDA currently has authority, but in some instances not 

resources to actually conduct, you know, the kinds of postmarket 

oversight as necessary. 

They have begun to take some good steps in that area. They have 

a Med Sun system that they have created where they have some 

additional surveillance, more active surveillance system ongoing. 

They haven’t had the resources to be able to review all the reports 

that are coming in that are being generated by that system. So 

that kind of control, we think, would be important for them to be 

able to exercise to have a better understanding and, as was just 

stated, to be able to identify some of the problems that may be 

cropping up more quickly to be able to take actions more readily 


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and to ensure that they are on top of whether companies are following through on the commitments that they have requested at 

the time that something is cleared or approved for marketing. So 

those kinds of controls. 

Mr. BURGESS. Does that fit with, you know, your description? In 

a perfect world, the FDA would be the one that finds problems and 

alerts the health care committee to the problem. But the reporting 

system is such that after just a few adverse events, the FDA at 

least should develop some institutional curiosity as to investigate 

these. 

Dr. MAISEL. Right, I mean I don’t think the FDA should be the 

only one, and I think that Congress recognized that when they set 

up this system. We need people on the front lines reporting the adverse events and the device malfunctions. And for the most part, 

manufacturers actually do a really great job of taking their product 

and the reports of malfunctions and figuring out what goes wrong 

and fixing the devices and resubmitting 510(k) applications. That 

is what we want them to do. 

But it would be nice for the FDA to be able to take the 200,000 

device adverse event reports that they get and be able to sort 

through those and find a pattern of malfunction or devices that are 

going wrong with this large database they have. And there will be 

investments in information technology, and they are moving in that 

direction. 

Mr. BURGESS. Well, I was just going to ask you. What is it that 

prevents that from happening today? Is it the IT architecture that 

is available? 

Dr. MAISEL. I think that is a major component. The other component is that the quality of the data they get is suspect. An adverse 

event report could say patient had device implanted and died, and 

that could be the entire report. So a lot of times, they are spending 

time calling clinicians or trying to figure out what really happened. 

They might not even know the serial number of the device or the 

company that made the device. It is very difficult for them to connect the dots, and it is going to require significant investment. 

Mr. BURGESS. Well, now you had a patient who had an 

implantable cardiac device and had an adverse event. Did you report that? How did you go about notifying the FDA that there was 

a problem, or was that problem already recognized so this was just 

one of many? 

Dr. MAISEL. It was both. I mean the device had already been recalled. The patient had been informed that his device was recalled. 

We had had a discussion about the management options, and the 

lowest risk option for him was to leave the device in place. And unfortunately he had an adverse event. I reported it to the FDA via 

the Med Watch system, but for an outlier of all the adverse event 

reports reported to the FDA about over 95 percent come from manufacturers. It is very rare that health care providers report adverse 

events. There is a little incentive for them to do it other than it 

is the right thing to do in the goodness of their heart. They don’t 

get paid for it. It takes a considerable amount of time. 

Mr. BURGESS. Would a provider limit future liability that they 

might incur if they went through the adverse reporting system, 

much like NASA has for the air traffic control system? There is a 


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get out of jail free card if you report an adverse event in the nation’s skyways. Do we have such a thing for adverse events? 

Dr. MAISEL. No, and I am not really sure that that would have 

any impact on the reporting. I don’t think physicians are—my 

sense is events aren’t being reported because they are concerned 

about liability. They have, like you, a busy day, and there is 10 

minutes of their day that they don’t have to give away. They can 

go do something else, and no one is going to come after them. And 

they don’t have to do it so it is not required. 

Mr. BURGESS. Just one other observation on the AEDs because 

this has been important, and, yes, this committee has been involved. And I have been involved with my state legislators back 

home in Texas to get these devices at water parks and high school 

football games and what have you. And I will never forget a town 

hall meeting I had in South Lake, Texas one time when a man 

went into v-tac and v-fib sort of in the waiting area. And they fortunately had an AED, but it was locked up in the basement downstairs. So it really didn’t do anyone any good. And I can tell this 

story because the paramedics arrived quickly, and the AED, in fact, 

saved his life. 

But after I got back up here to the capital, I began to look 

around. Where are our AEDs? I was informed that we had appropriated money and we had purchased the AEDs, and they were indeed locked up in a cabinet somewhere because we hadn’t gotten 

permission from the architect of the Capitol to place the cabinets 

and we hadn’t agreed on the type of cabinetry that should be 

placed in the historic buildings around the Capitol. 

So, you know, you can do all the right things and still be left 

with—at some point, the decision tree falls apart, and you don’t get 

the information or the device into the hands of the people who need 

it. 

Dr. Maisel, based on your experience chairing the Food and Drug 

Administration’s postmarket heart device advisory panel, on the 

panel, how long does it take you to review a device when it comes 

to your attention, when there is a report made? 

Dr. MAISEL. The sponsor of the device in the FDA prepare a pretty remarkable panel pack that often runs into hundreds of pages 

that includes both the administrative record, our review of the 

bench testing and engineering, the clinical studies. And then we 

get it several weeks in advance, and, you know, it takes hours, you 

know, probably 10 hours or more to review. And then we usually 

have an eight-hour meeting to discuss the results. 

Mr. BURGESS. So it is somewhat cumbersome and time consuming? 

Dr. MAISEL. I guess it depends on your perspective. 

Mr. BURGESS. Now, April this year, there were some Food and 

Drug Administration employees that sent a letter to the President 

saying that the device process was essentially broken. Now, is that 

a statement that you could find agreement with, or do you think 

that is an overreaction? 

Dr. MAISEL. I don’t know that I want to comment on what these 

individuals said because I don’t know what their allegations were 

based on. I will say I think we are here today because we all feel 

that there are things that can be done better. I can say in working 


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with literally hundreds of individuals at the FDA, I have yet to 

come across someone who I did not feel was trying to do the right 

thing for the American public. 

It is not like there are people walking around at the agency who 

are trying to circumvent the rules. I think they are trying to do the 

best they can with the resources that they are given. 

Mr. BURGESS. So the motives are pure, but what about, then, the 

process itself? And what about the 510(k) process? And we have 

heard testimony that it may not even involve clinical testing in humans. It may be just simply bench testing, or it may be testing in 

laboratory animals. 

Dr. MAISEL. I think, you know, I think Congress has done an 

amazing job of giving FDA a roadmap, a recipe book of what they 

are supposed to do for certain types of devices. But there is leeway 

in that roadmap. There is judgment that the FDA needs to apply 

to a given device in a given situation. And I think one of the problems is that judgment is applied inconsistently. 

And I think, for obvious reasons, we are focusing a lot on the 

510(k), but I don’t think we should completely ignore the PMA 

process. Yes, it represents only one percent of devices, but some of 

those individual devices go out to several million people. I mean 

there are tens of millions of people who get PMA devices. Four out 

of five PMA devices are approved via the PMA supplement pathway, not via the original PMA pathway. And the PMA supplement 

pathway, 80 percent of the PMAs approved is a much, much lower 

bar. 

A lot of those PMA supplements are 180-day PMA supplements, 

which is a class that Congress set up, and that doesn’t necessarily 

require clinical data. The Sprint Fidelis lead that my patient had 

is a perfect example. That was approved via a PMA supplement, 

zero clinical data before this life-sustaining device goes into people. 

Mr. BURGESS. Well, given that, and just speaking of the 510(k) 

world for a moment, what changes to that process would you suggest? And are those changes within the purview of the FDA and 

within the tools that they have right now? Or is that going to require additional input from Congress? 

Dr. MAISEL. I do believe that the FDA has most of the tools that 

they need. Whether they will use them and be applied is a different 

story, and so that is sometimes where Congress can obviously help 

and direct them to apply. I think that there needs to be better clarification of which type of 501(k) devices should have clinical data 

associated with them. I don’t think it should be a case-by-case 

basis. I am a reviewer sitting at the FDA, and I am going to look 

at this device and make my best judgment. 

There need to be standards. There need to be guidance, I think 

from Congress, to the FDA about what you expect, what we expect 

to see for certain types of products. And it should be based on the 

risk of the product, and it should be based on the risk to patients. 

I think you could weigh in the effectiveness as well, as we spoke 

about. I mean for a product that is a life-sustaining product that 

is a really important product, I am willing to accept a different 

safety standard. I am willing to have less data if it is a really important product. And for products that are a me-too product, and 


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we have other products that are just as helpful, I think the standards are different. 

But I think Congress can help by clarifying the standards for the 

FDA or at the very least, FDA needs to be more transparent about 

how they are going to apply their standards. 

Mr. BURGESS. You may be overestimating the ability of Congress, 

but you can ask. I appreciate the acknowledgement. Let me ask 

you a question that is really not fair and it calls for rank speculation and you may regret—— 

Dr. MAISEL. I am good at that so—— 

Mr. BURGESS. Yeah, me too. You may regret that you stayed here 

all day, but we are faced now—this is an important issue that we 

are dealing with. And we need to get it right, and the fact that we 

have been here all day focusing on it indicates that there is a problem that we need to get right. 

Now, we are also in the process of looking at very complex biologic molecules, and I realize they are not devices. These are medications. The issue of follow-on biologics is coming up to our committee, and we are helping the FDA decide the best way to approach the assessment of so-called follow-on product. 

And it seems to me there are so many similarities here. I mean, 

although one is a device and one is a complex biologic molecule, we 

are talking about using a certification procedure that is somewhat 

abbreviated or at least has the flexibility to be somewhat shortened 

from what the normal procedure would be. In this case, in the biologics case, going through a new drug application. And in the device case, going through the full PMA rather than a 510(k) process. 

Is that an unfair analogy to draw between the issue of follow-on 

biologics and the issue that we are dealing with here today with 

the 510(k) process? 

Dr. MAISEL. Well, I think you have described it well. I mean they 

do have components of both drugs and devices. I think the lesson 

would be we don’t know a lot about them. There is a lot we still 

need to learn about biologics. And we need to have a total product 

life cycle. We can’t just have a premarket evaluation and put them 

on the market and start having patients get them and then forget 

about them. 

At the same time, we don’t want them to go into patients and 

just study them after they are into hundreds or thousands of patients. So I think that whatever program is established needs to 

carefully balance the benefit to patients or at least the potential 

benefit to patients so that we can get these important products out 

to them quickly, but at the same time study them. Require 

postmarket studies so that we can make sure that the products are 

doing what they are supposed to do and that patients are safe. 

Mr. BURGESS. And the concept of the life cycle is one that is really extremely important because many of these devices are implanted in someone whose forward life expectancy may be two, 

three, or four decades. And is the device capable of holding up in 

conditions inside the human body over that time and particularly 

the artificial joint replacements that we have seen. 

And even getting into dental procedures. There can be analogous 

situations there. I really do appreciate you sharing that with us 

today. Mr. Chairman, I am going to ask that since Dr. Lurie, I 


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guess, had to leave, and I had a set of questions that I wanted to 

pose to him. But can I do that in writing? 

Mr. PALLONE. Absolutely, and I said to the panel that since a lot 

of the members didn’t come back you should expect that you will 

get some written questions. Usually we ask the members to get 

them in within the next 10 days. 

Mr. BURGESS. You can have them before I leave. 

Mr. PALLONE. Well, we will, you know, open the record obviously 

for the written questions in light of—well, we always do anyway 

but particularly today because of the long day. 

Mr. BURGESS. Let me just ask Mr. Phillips one final question because he has been so patient to sit here all day. Now, we have 

heard testimony, it seems like hours ago now, that only 10 to 15 

percent of 501(k) submissions contain any clinical data, and you obviously have had some experience working at the FDA. Do you 

think that within the 501(k) approval process that there should be 

some clinical data available or some clinical trials performed? 

Mr. PHILLIPS. I think without question the answer is yes because 

what we have seen is clearly over time evolution and technology 

changes. We talked about, Dr. Lurie talked about issues of intended use, and without question, when you start dealing with 

changes in intended use and changes in technology, invariably, 

there is going to be situations where you are going to have to have 

human experience. 

Mr. BURGESS. And so you really answered the second part of that 

question. It should be human. It cannot be just bench testing or 

animal testing. 

Mr. PHILLIPS. You know it is interesting because I, you know, 

through my career, I have hung out with a lot of engineers. And 

to a very large extent, you find that you can get a lot of precise 

information regarding engineering analysis. We talked about, for 

example, the breakage of a lead. There is a lot that you can do to 

characterize the strength and integrity of a lead. 

I think that, you know, for premarket evaluation, there has to be 

a balance that is struck. And I think that we talk about the total 

product life cycle, and I think from an FDA regulatory perspective, 

they have to have the controls in place to provide adequate assurance, reasonable assurance of safety and effectiveness in the short 

term. But I think there needs to be postmarket controls so that you 

can monitor in a very vigilant way performance once products get 

to market. 

I think that there are many situations where it is perfectly reasonable to allow a product to go to market based upon preclinical 

engingeering analysis and data. But in order to do that, you have 

to have high confidence that you have mechanisms in place that 

are going to be able to pick up problems once products are out and 

available in a much larger population. 

You know clinical trials with medical devices, a large clinical 

trial is 200 to 300 patients for a medical device. And clearly there 

is a limit as to how much you can even detect in a relatively small 

patient population. And keep in mind the duration of trials, a long 

trial is a two-year trial for a medical device. And many of these 

products, as you just indicated, are going to be placed into individuals for very lengthy periods of time, perhaps the rest of their life. 


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So I think that there has to be a focus on trying to figure out 

what the proper premarket, postmarket balance is so that we don’t 

develop a system which really becomes a deterrent to industry, innovating and developing new technologies but gives the American 

public the confidence that once products are made available, that 

there are mechanisms in place to pick up any kind of events that 

represent, you know, something of significance that they need to 

know about or other clinicians need to know about. 

Mr. BURGESS. Well, Dr. Lurie also referenced a compound that 

was used for articular surfaces and the fact that this was a weightbearing structure made a difference as well. So something like that 

where there is a long length of time for intended use in someone’s 

body. And there is a special situation that this is a weight-bearing 

structure. It seems to me, and I think obviously I am no expert, 

but it seems to me that this is one of those situations that would 

not lend itself to a facilitated or abbreviated process but one where 

you would want to have the availability of all the data possible and 

then the longitudinal studies since again we are talking about 

something that exists over—is intended to be used over a long period of time, longitudinal studies become very important as well. 

Would you not agree with that? 

Mr. PHILLIPS. Well, I would agree with that in concept, but let 

me also disclose that the example that Dr. Lurie was addressing 

in his remarks this morning, I am an actual consultant for that 

company. So I want to make sure that everybody is aware that 

there is that relationship. 

But, you know, it is interesting because I think that you need to 

look at the body of evidence that was provided on that particular 

device as well. It was a 510(k) clearance, but there was a tremendous amount of data, in fact a lot more data in that submission 

than what is in the vast majority of 501(k) applications. 

There can be a lot of discussion as to the quality of the data, 

what that data established, but I think for all practical purposes, 

the intended use of that device was well corroborated with the data 

that was included in this submission. 

I understand that Dr. Hamburg and Dr. Sharpstein are looking 

into that issue right now, and interested to find out what their assessment is. 

Mr. BURGESS. Well, Mr. Chairman, I will just come back to 

where I started this morning. It begs the question where is the 

FDA. So I hope we will have a follow-up hearing at some point, and 

I know the calendar is condensed and compressed. And we are all 

pressed for time, but it is hard to have this type of hearing on this 

type of evaluation and evaluating rather the process the FDA uses 

without having the FDA here to weigh in on it. 

And, Dr. Maisel, let me just say too I am so grateful you are 

here. And we have heard so much from the science board on the 

FDA that yeah, we need to fund. They do need more money, but 

the procedures and the policies are things that need to be looked 

at as well. 

And then, of course, in the brave new world of the FDA regulating tobacco, and I don’t know how you ever decide that it is— 

you can decide that it is effective, but I don’t know how you ever 

decide that it is safe. And they have a mission that is—we have 


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given them a mission that is virtually impossible for them to perform. 

But really appreciate all the witnesses being here today and 

staying with us so long. I will yield back to the chairman. 

Mr. PALLONE. Thank you, Dr. Burgess. Again thanks, you know, 

for your patience, but I am glad that you came back and we were 

able to ask the questions that we did ask today. We will have some 

more written questions, but thanks again. Have a good and safe 

trip home. And without further ado, the subcommittee hearing is 

adjourned. 

[Whereupon, at 7:35 p.m., the Subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


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