2005 

CDRH FY 2005 

Highlights 

Reporting for the period between 

October 1, 2004 and September 30, 2005 

 

 

 

 
Table of Contents 

MESSAGE FROM THE CENTER DIRECTOR ............................................ 7

INCREASING ACCESS TO INNOVATIVE TECHNOLOGIES....................... 9

ENABLING TECHNOLOGY AND INNOVATION.........................................................9

MINIMALLY INVASIVE SURGERY...............................................................................................................9

ORAL RINSE FOR GINGIVITIS.......................................................................................................................9

SURGICAL LASER FOR ASSISTED REPRODUCTION................................................................................9

TREATING ANEURYSMS OF THE THORACIC AORTA ...........................................................................10

DURA MATER SEALANT FOR NEUROSURGERY ....................................................................................10

DRUG-ELUTING PACEMAKER LEAD RELEASING STEROID TO IMPROVE HEALING....................10

NEW PROSTHETIC JAW JOINT....................................................................................................................10

FIRST DNA-BASED TEST FOR A DRUG METABOLIZING ENZYME.....................................................10

NEW TECHNOLOGY FOR MAINTAINING PATIENT DATA....................................................................11

THE FIRST SURGICAL MARKER WITH RFID TECHNOLOGY ...............................................................11

 PREVENTION OF FUTURE STROKES ........................................................................................................11

ARTIFICIAL INTERVERTEBRAL DISC.......................................................................................................11

PROVIDING CIRCULATORY SUPPORT FOR HOSPITALIZED PATIENTS AWAITING HEART 

TRANSPLANTATION .....................................................................................................................................12

TEMPORARILY IMPROVING INSUFFICIENT BLOOD FLOW TO THE BRAIN.....................................12

MDUFMA ...........................................................................................................12

DOCUMENTS, NOTICES AND REPORTS RELATED TO MDUFMA........................................................13

THIRD PARTY INSPECTION PROGRAM ....................................................................................................13

MDUFMA STAKEHOLDERS ANNUAL MEETING.....................................................................................13

SMALL BUSINESS DETERMINATIONS (SBD)...........................................................................................13

MDUFMA PERFORMANCE...........................................................................................................................14

TRAINING AND PROFESSIONAL DEVELOPMENT ..................................................................................14

GUIDANCE DEVELOPMENT ........................................................................................................................14

UTILIZING EXTERNAL EXPERTISE ......................................................................14

CDRH ADVISORY COMMITTEES................................................................................................................14

MEDICAL DEVICE FELLOWSHIP PROGRAM (MDFP).............................................................................15

THIRD PARTY REVIEW PROGRAM ............................................................................................................15

MAINTAINING THE QUALITY OF PREMARKET REVIEWS....................................16

CDRH QUALITY REVIEW PROGRAM.........................................................................................................16

IMPROVING PROBLEM DETECTION..................................................... 17

IMPROVING POSTMARKET SURVEILLANCE ........................................................17

MEDICAL DEVICE POSTMARKET TRANSFORMATION INITIATIVE ..................................................17

IMPROVING COORDINATION OF POST-APROVAL STUDIES ...............................................................17

CDRH FY 2005 Annual Report 2
DEVELOPING A MEDICAL DEVICE ELECTRONIC ADVERSE EVENT REPORTING SYSTEM.........18

USING TARGETED SURVEILLANCE: THE MEDSUN NETWORK..........................................................18

DETECTION OF ADVERSE MEDICAL DEVICE EVENTS WITH ELECTRONIC DISCHARGE 

RECORDS.........................................................................................................................................................19

ACTIVE DEVICE SURVEILLANCE ..............................................................................................................19

DATA MINING.................................................................................................................................................20

MINIMIZING USER-RELATED HAZARDS .............................................................20

HUMAN FACTORS AND LABELING...........................................................................................................20

INTERNATIONAL PROGRAMS ...............................................................................21

GLOBAL HARMONIZATION ........................................................................................................................21

IMPROVING COMMUNICATION OF MEDICAL TECHNOLOGY 

INFORMATION....................................................................................... 22

INCREASING ACCESS TO INFORMATION ON REGULATED PRODUCTS AND 

HEALTH ISSUES....................................................................................................22

MEDICAL DEVICE RECALL WEB SITE......................................................................................................22

PUBLIC HEALTH NOTIFICATIONS .............................................................................................................22

FDA PATIENT SAFETY NEWS (FDA PSN)..................................................................................................23

TOPIC-SPECIFIC WEB SITES................................................................................23

FDA & YOU......................................................................................................................................................23

EXPLORING WAYS TO IMPROVE ACCESS TO CDRH’S INFORMATION .............24

SMALL MANUFACTURERS, INTERNATIONAL AND CONSUMER ASSISTANCE..............................24

E-CONSUMER INITIATIVE ....................................................................................25

NEW WEB FEATURES ...................................................................................................................................25

IMPROVING COMMUNICATION .................................................................................................................25

IMPROVING THE COMMUNICATION INFRASTRUCTURE......................................26

UNITING PRE AND POSTMARKET: CDRH DEFIBRILLATOR WORKING GROUP.............................26

INFORMATION TECHNOLOGY (IT) SOLUTIONS.....................................................................................26

COLLABORATING TO PROMOTE EFFECTIVE PUBLIC HEALTH COMMUNICATION

..............................................................................................................................27

POLICY CONFERENCE ON IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS) AND 

PACEMAKERS.................................................................................................................................................27

RETROSPECTIVE REVIEW OF PACEMAKERS AND IMPLANTABLE CARDIOVERTER 

DEFIBRILLATORS (ICDS) .............................................................................................................................27

PROMOTING THE SAFE USE OF INFUSION PUMPS ................................................................................28

EDUCATING HEALTH PROFESIONALS: TROPONIN...............................................................................28

BUILDING QUALITY INTO DEVICE CLINICAL TRIALS WORKSHOP..................................................28

510(K) WORKSHOP FOR NEW MANUFACTURERS..................................................................................28

FDA MEDICAL DEVICE WORKSHOP .........................................................................................................29

WORKSHOP ON DRUG-DIAGNOSTICS TRANSLATIONAL RESEARCH ..............................................29

USING RISK INFORMATION TO PROTECT THE PUBLIC ...................... 30

CDRH FY 2005 Annual Report 3
PROTECTING HUMAN RESEARCH SUBJECTS AND CONFRONTING RESEARCH 

MISCONDUCT .......................................................................................................30

APPLICATION OF INTEGRITY POLICY......................................................................................................30

REMOVAL FROM THE APPLICATION INTEGRITY POLICY LIST AND THE INTEGRITY HOLD 

LIST...................................................................................................................................................................30

NOTICE OF INITIATION OF DISQUALIFICATION PROCEEDING AND OPPORTUNITY TO EXPLAIN 

LETTERS (NIDPOE)........................................................................................................................................31

INSTITUTIONAL REVIEW BOARDS (IRBS) FAILURE TO IMPLEMENT CORRECTIVE ACTIONS 

RESULTED IN FDA WITHHOLDING APPORVAL OF NEW STUDIES ....................................................31

IMPROVING PRODUCT QUALITY AND SAFETY THROUGH BETTER 

MANUFACTURING OVERSIGHT............................................................................33

DEVELOPING A COMPLIANCE AND ENFORCEMENT TRACKING SYSTEM .....................................33

PROTECTING THE PUBLIC...........................................................................................................................33

PRIORITIZING COMPLIANCE-RELATED ACTIVITIES ..........................................33

RISK-BASEB INSPECTION WORK-PLAN AND REGULATORY ACTIONS............................................33

EXCEEDING YEARLY INSPECTION GOALS .............................................................................................34

CLINICAL LABORATORIES IMPROVEMENTS ACT (CLIA)..................................34

STREAMLINING THE CLIA APPLICATION PROCESSS ...........................................................................34

MAMMOGRAPHY QUALITY STANDARDS ACT (MQSA)......................................35

MQSA FACILITY INSPECTIONS ..................................................................................................................35

10 YEARS OF MQSA INSPECTIONS ............................................................................................................35

RADIATION SAFETY .............................................................................................35

RADIOLOGICAL HEALTH IMPLEMENTATION PROGRAM ...................................................................35

REDUCING UNNECESSARY EXPOSURE FROM SOURCES REGULATED BY FDA ............................35

AMENDING GLOBAL LASER REGULATION ............................................................................................36

NEW TECHNICAL STANDARDS FOR FLUOROSCOPY EQUIPMENT....................................................36

PROMOTING DEVELOPMENT OF CONSISTENT POLICIES ON REDUCING EXPOSURE TO THE 

GENERAL PUBLIC..........................................................................................................................................36

ASSESSING THE IMPACT OF LEGAL AND ILLEGAL USE OF RADIATION-EMITTING PRODUCTS

...........................................................................................................................................................................37

RADIOLOGICAL HEALTH CIVIL MONEY PENALTY ASSESSED AGAINST A MANUFACTURER OF 

TELEVISION PRODUCTS ..............................................................................................................................37

EXPANDING PATIENT PROTECTION THROUGH APPLIED RESEARCH ................37

DEVICE SAFETY IN MAGNETIC RESONANCE IMAGING (MRI) ENVIRONMENTS...........................38

EXPIRATION DATE FOR MEDICAL GLOVES ...........................................................................................38

MECHANICAL STRENGTH OF VERTEBRAE FOLLOWING INJECTIONS WITH BONE GLUE..........38

EXPOSURE TO ELECTROMAGNETIC FIELDS AND ITS EFFECTS ON IMPLANTED DEVICES........38

EFFECTIVENESS AND SAFETY OF INTRAOCULAR LENSES (IOLS)....................................................39

COMBINED APPROACH TO EVALUATE CIRCULATORY ASSIST DEVICES ......................................39

EFFECTS OF OPTICAL ENERGY..................................................................................................................39

DEVICE-TISSUE INTERFACES.....................................................................................................................39

BETTER ANIMAL MODELS AND BIOMARKERS TO IMPROVE PUBLIC HEALTH ............................40

INFECTION CONTROL: REUSE OF SINGLE USE DEVICES AND CLEANING VALIDATION...........40

DRUG COATED STENTS: DRUG ELUTING STENTS ASSOCIATED THROMBOSIS ...........................40

COMPUTATIONAL FLUID DYNAMICS OF LEFT VENTRICULAR ASSIST DEVICE...........................41

COMPUTER-ASSISTED DIAGNOSTIC SYSTEMS......................................................................................41

PERFORMANCE TESTING OF PULSE OXIMETERS..................................................................................41

CDRH FY 2005 Annual Report 4
TEST METHODS FOR HIGH INTENSITY FOCUSED ULTRASOUND .....................................................41

CDRH STANDARDS PROGRAM...................................................................................................................42

REGULATIONS AND GUIDANCE DEVELOPMENT..................................................42

PREPARING AND RESPONDING TO EMERGENCIES.............................. 44

RESPONDING TO HURRICANE KATRINA.................................................................................................44

CONTINUATION OF OPERATIONAL PLANNING (COOP).......................................................................45

OBTAINING INFORMATION................................................................... 46

ANNUAL REPORTS................................................................................................46

CDRH WEB SITES ...............................................................................................46

CDRH FY 2005 Annual Report 5
CDRH

Promoting and protecting public health by ensuring the safety and 

effectiveness of medical devices and the safety of radiological products 

Ensuring the health of the public throughout the Total Product Life 

Cycle 

www.FDA.Gov/CDRH 

CDRH FY 2005 Annual Report 6
MESSAGE FROM THE CENTER 

DIRECTOR

Dear Reader, 

I’m pleased to issue the annual report for FDA’s Center for Devices and Radiological 

Health, which highlights both the challenges we faced and the goals we met during Fiscal 

Year 2005. This letter briefly summarizes some of the major accomplishments described 

in the report. I encourage you to visit CDRH’s web site at www.fda.gov/cdrh to read the 

full report and learn more about what we do. 

FY 2005 was the first year that the majority of MDUFMA performance goals went into 

effect. I’m pleased to report that hard work and preparation paid off—we not only 

fulfilled MDUFMA requirements, but maintained device review performance in areas not 

covered by MDUFMA. And we’re now in the process of preparing for MDUFMA II. 

Seventy percent of our resources were related to MDUFMA activities in FY2005. This 

involved all aspects of the review process, including condition of approval studies, 

statistical review, human factors review, labeling review, research and consultation, 

review of manufacturing practices, pre-approval inspections and third party inspections. 

With MDUFMA, we are making significant strides in our premarket programs. But our 

responsibility to public health goes beyond premarket review. We also need to transform 

our postmarket program to better monitor the safety of medical devices after they reach 

the market. This year we took a major first step in that direction with a comprehensive, 

year-long internal inventory of the tools used to monitor the safety of medical devices 

after they are in use. The inventory identified areas where we are performing well, as 

well as those where we need to improve. With the inventory as a roadmap, we will take 

steps to enhance our ability to identify, analyze, and act on problems quickly, so that we 

can better alert patients and health professionals about medical device safety issues. 

In order to get our medical device safety messages to the people who need them, we must 

have an effective communications system that will link us with clinicians, medical 

institutions, patients and the general public. To help satisfy that need, we began a 

systematic review of our medical device websites to enhance our information on product 

safety and to make our web pages more accessible and user-friendly. We began research 

to determine whether our safety messages meet the needs of patients and the healthcare 

community. I’m also pleased to report that “FDA Patient Safety News,” our video news 

show for health professionals, continues to attract new viewers, with a 40 percent 

increase in visitors to the show’s dedicated website in FY 2005. 

Medical device technology is moving forward at incredible speed, and our internal 

research programs help us keep pace with emerging science. They make an important 

CDRH FY 2005 Annual Report 7
contribution to our product review process, and help stimulate the development of new 

evaluation tools. For example, CDRH scientists conducted research in 2005 that aided in 

the evaluation of a post-approval study application for a pediatric left ventricular assist 

device (LVAD). 

In an age of rapid scientific and medical progress, it is vital that we strengthen our 

interactions with the academic and clinical communities. Our Medical Device 

Fellowship Program continues to attract outside experts to work with us on a short-term 

basis, sharing their expertise and gaining insight into our policies and public health 

mission. At the same time, the Center’s Staff College helps to assure that the knowledge 

and qualifications of our own staff are continually enhanced. 

In FY 2005 CDRH commemorated 10 years of Mammography Quality Standards Act 

inspections. In that decade, MQSA inspectors have completed 93,000 inspections of 

mammography facilities. I’m pleased to note that the percentage of inspections without 

adverse observations has increased, and continues to do so. In FY 2005 we also 

published amendments to the mandatory medical x-ray performance standards that should 

significantly reduce patient radiation exposure from fluoroscopy. 

We were presented with an unusual challenge in FY 2005 because of Hurricane Katrina. 

We responded quickly by issuing advice on the disposal of contaminated devices, the 

reopening of dialysis centers, and how to deal with medical devices that have been 

exposed to high heat and humidity and those that require refrigeration. I am especially 

proud of all of the volunteers in the Center who traveled to New Orleans and other hardhit areas to help in the recovery effort. 

To sum up, I’m proud of our accomplishments, but I’m also aware of the challenges that 

lie ahead: improving the efficiency and quality of our premarket review system, 

strengthening our postmarket program to provide a strong public health safety net for 

products already in use, focusing our research program to better address emerging 

regulatory issues, communicating more effectively within the Center, with healthcare 

professionals, patients and the medical device industry, improving our lines of 

communication with the academic and clinical communities, and assuring that our own 

staff is adequately trained to deal with the challenging new technologies on the horizon. 

None of the progress outlined in this letter could have occurred without the commitment 

and hard work of everyone in the Center. I’m proud of them and grateful for their 

dedication to the public health. 

 

 Daniel G. Schultz, M.D. 

 Director, Center for Devices and 

 Radiological Health 

CDRH FY 2005 Annual Report 8
INCREASING ACCESS TO INNOVATIVE 

TECHNOLOGIES

ENABLING TECHNOLOGY AND INNOVATION

The following devices are examples of advanced device technologies that FDA approved 

or cleared during FY 2005. A comprehensive list of approved medical devices is 

available at http://www.fda.gov/cdrh/consumer/mda/index.html. 

MINIMALLY INVASIVE SURGERY 

http://www.fda.gov/cdrh/mda/docs/p040003.html 

The ExAblate 2000 System, manufactured by InSightec, is the 

first non-invasive surgery device to combine magnetic resonance 

imaging and focused ultrasound to target and destroy uterine 

fibroids. The device is intended to treat women who have completed childbearing or do 

not intend to become pregnant. It is an alternative to myomectomy, hysterectomy, 

watchful waiting, hormone therapy, or uterine fibroid embolization. 

ORAL RINSE FOR GINGIVITIS 

http://www.fda.gov/cdrh/mda/docs/k041482.html 

The Decapinol Oral Rinse, manufactured by Sinclair Pharmaceuticals 

Limited, is a prescription oral rinse. When used, the oral rinse forms a 

physical barrier to bacterial attachment on tooth surfaces. The interference 

to bacterial attachment reduces plaque associated with gingivitis. 

SURGICAL LASER FOR ASSISTED REPRODUCTION 

http://www.fda.gov/cdrh/mda/docs/k040045.html 

The Hamilton Thorne Zona Infrared Laser Optical System (ZILOS-tk®), 

manufactured by Hamilton Thorne Biosciences, Inc., is a microscope 

guided laser system used to drill a small hole in the zona pellucida, the 

hard membrane that surrounds the ovum, and facilitate embryo hatching prior to 

implantation. The device may increase implantation rates in older women (older than 37 

years) and patients utilizing frozen embryos. 

CDRH FY 2005 Annual Report 9
INCREASING ACCESS TO INNOVATIVE TECHNOLOGIES

TREATING ANEURYSMS OF THE THORACIC AORTA 

http://www.fda.gov/cdrh/mda/docs/p040043.html 

The GORE TAG Endoprosthesis System, manufactured by W.L. Gore 

and Associates, Inc., is the first endovascular grafting system approved 

to treat aneurysms of the descending thoracic aorta (in the chest). The 

device is intended to prevent aneurysm ruptures by making a new path for blood flow. 

The GORE TAG Endoprosthesis can be used instead of more invasive open surgery to 

repair the aorta, the main artery that carries blood in the body. 

DURA MATER SEALANT FOR NEUROSURGERY 

http://www.fda.gov/cdrh/mda/docs/p040034.html

The DuraSeal Dural Sealant System, manufactured by Confluent 

Surgical, Inc., is the first material approved for sealing leaks in the dura 

mater covering of the brain during neurosurgical procedures. The sealant is intended to 

aid in preventing cerebrospinal fluid leakage through suture wound edges of the dura 

mater is absorbable and will biodegrade within 4-8 weeks after application. 

DRUG-ELUTING PACEMAKER LEAD RELEASING STEROID TO 

IMPROVE HEALING 

http://www.fda.gov/cdrh/mda/docs/p030036.html 

 The SelectSecureTM Lead Model 3830, manufactured by Medtronic, Inc., 

is a surgically implanted wire that connects the heart to an implanted 

pacemaker. A steroid, beclomethasone dipropionate, is released into the body from the 

tip of the lead to improve healing after implantation. The lead, in conjunction with an 

implanted pacemaker, treats irregular or slow heart rhythm or bradycardia. If bradycardia 

is not treated, it can lead to fatigue, shortness of breath, dizziness, or fainting. 

NEW PROSTHETIC JAW JOINT 

http://www.fda.gov/cdrh/mda/docs/p020016.html 

The Total Temporomandibular Joint Replacement System, manufactured 

by Walter Lorenz Surgical, Inc., is a prosthetic jaw joint intended for 

patients who need a total jaw replacement due to severe arthritic 

conditions, fused joints, previous multiple surgeries, severe fractures, 

tumors, or severely degenerated joints. The device may reduce jaw pain, 

reduce interference with eating and increase the ability to open the mouth. 

FIRST DNA-BASED TEST FOR A DRUG METABOLIZING ENZYME 

http://www.fda.gov/cdrh/pdf5/K051824.pdf 

The Invader® UGT1A1 Molecular Assay, manufactured by Third Wave Technologies, 

Inc., is intended to help doctors make personalized drug treatment decisions. This assay 

CDRH FY 2005 Annual Report 10
INCREASING ACCESS TO INNOVATIVE TECHNOLOGIES

enables doctors to use a patient’s genetic information for determining whether to modify 

the dose for drugs that are broken down in the body by UGT enzymes. Drug dose 

modification could minimize harmful drug reactions and prevent patients from being 

improperly treated with suboptimal doses. The Invader assay joined a growing list of 

DNA-based tests used for individualized medical care. 

NEW TECHNOLOGY FOR MAINTAINING PATIENT DATA 

http://www.fda.gov/cdrh/pdf3/k033440.pdf

The VeriChip Implantable Radiofrequency Transponder System, 

manufactured by Applied Digital Solutions, consists of an 

implantable chip, an introducer, and a reader. After the chip is 

implanted under the skin, a caregiver is able to retrieve a unique 

patient identifier and patient medical information from a prescription web site when the 

patient is otherwise unable to provide this information. The medical information on the 

web site is supplied by the patient and can only be accessed with appropriate 

authorization. 

THE FIRST SURGICAL MARKER WITH RFID TECHNOLOGY 

http://www.fda.gov/cdrh/pdf4/k042555.pdf

The SurgiChip Tag Surgical Marker system, manufactured by SurgiChip I

is the first surgical marker to use radio frequency identification (RFID) 

technology to mark an anatomical site for surgery. This external surgical 

s intended to lessen the likelihood of wrong-site, wrong-procedure an

wrong-patient surgeries. 

nc., 

marker tag i d 

 PREVENTION OF FUTURE STROKES 

http://www.fda.gov/cdrh/mda/docs/p040038.html

The Xact® Carotid Stent System, manufactured by Abbott Vascular 

Devices, is used to open blood vessels in patients who have had a stroke, who have a very 

tight blockage in the vessels of the neck, and who have counter indications for the 

surgical alternative. The device, a mesh stent with delivery catheter (Xact® Carotid Stent 

System), is used in combination with a micromesh filter basket on a catheter to trap loose 

debris particles (Emboshield Embolic Protection System). 

ARTIFICIAL INTERVERTEBRAL DISC 

http://www.fda.gov/cdrh/mda/docs/p040006.html

The CHARITETM Artificial Disc, manufactured by DePuy Spine, Inc, is 

indicated for use in spinal reconstruction in patients with degenerative 

disc disease. The device consists of an artificial intervertebral disc of metal and plastic 

that is surgically implanted to replace a diseased or damaged intervertebral disc. The 

CDRH FY 2005 Annual Report 11
INCREASING ACCESS TO INNOVATIVE TECHNOLOGIES

artificial disc may restore disc height, reduce pain, and allow movement at the level 

where it is implanted.

PROVIDING CIRCULATORY SUPPORT FOR HOSPITALIZED 

PATIENTS AWAITING HEART TRANSPLANTATION 

http://www.fda.gov/cdrh/mda/docs/p030011.html

The Syncardia Temporary CardioWest Total Artificial Heart (TAH-t), 

manufactured by SynCardia Systems, Inc., is indicated for use in heart 

transplant-eligible candidates at risk of imminent death from 

biventricular heart failure. The artificial heart provides circulatory 

support for the hospitalized patients who are awaiting heart 

transplantation. The device also improves kidney and liver functions because normal 

blood flow is restored—making the patient a better candidate for heart transplantation. 

TEMPORARILY IMPROVING INSUFFICIENT BLOOD FLOW TO THE BRAIN 

http://www.fda.gov/cdrh/mda/docs/h030005.html 

The NeuroFloTM Catheter, manufactured by CoAxia, Inc., is used to treat cerebral 

ischemia, insufficient blood flow to the brain, resulting from symptomatic vasospasm. 

Symptomatic vasospasm, the squeezing down of a blood vessel in the brain, results in 

symptoms similar to stroke such as difficulty in speaking, movement, or understanding. 

The NeuroFlo Catheter is intended to increase blood flow to the upper body and brain by 

temporarily reducing blood flow to the lower part of the body. 

MDUFMA 

FDA worked to implement the Medical Device User Fee and Modernization Act 

(MDUFMA) of 2002. MDUFMA allows CDRH to collect user fees from companies that 

submit medical device applications. CDRH has used the additional funds to hire 

additional staff expertise and develop better systems to support more effective and timely 

review. 

MDUFMA requires CDRH to pursue a complex and comprehensive set of review goals 

that are more aggressive each successive year. CDRH reports on performance relative to 

the specified goals at the end of each year. In FY 2005 CDRH fulfilled MDUFMA 

statutory requirements and maintained device review performance in areas not covered 

by official performance goals. Enactment of the Medical Device User Fee Stabilization 

Act of 2005 provided the final action necessary to satisfy the Committee’s request for 

CDRH FY 2005 Annual Report 12
INCREASING ACCESS TO INNOVATIVE TECHNOLOGIES

“updates on the progress of the MDUFMA legislative change.” The Stabilization Act 

enabled the legislative changes required to continue the medical device user fee law 

through FY 2007. Information about MDUFMA is available at 

http://www.fda.gov/cdrh/mdufma/index.html. 

DOCUMENTS, NOTICES AND REPORTS RELATED TO MDUFMA 

In FY 2005 CDRH published three Federal Register notices about MDUFMA 

implementation. In addition, for FY 2005, CDRH prepared three reports to Congress 

related to MDUFMA: 

• Annual Report to Congress on the Office of Combination Products for FY 2005 

• Annual Financial Report to Congress –for FY 2005 

• Annual Performance Report to Congress –for FY 2005 

THIRD PARTY INSPECTION PROGRAM 

http://www.fda.gov/cdrh/ap-inspection/ap-inspection.html

CDRH continued implementation of the MDUFMA Accredited Persons (APs - Third 

Party inspection) program designed to reduce regulatory burden on providers, patients, 

and consumers of health and human services by increasing efficiency and modernizing 

regulatory oversight. During FY 2005 the number of qualifying inspections for APs 

increased by 10 percent. Currently, 5 of 16 APs are eligible to conduct independent 

inspections for the FDA. In a letter to 8,600 domestic Class II and Class III device 

establishments, CDRH announced the publication of the AP Eligibility Guidance and 

outlined the benefits to manufacturers who use an AP to conduct their AP inspections. 

MDUFMA STAKEHOLDERS ANNUAL MEETING 

http://www.fda.gov/cdrh/meetings/111804.html 

CDRH held the 2nd Annual Stakeholder Meeting on the Implementation of MDUFMA on 

November 18, 2004. This meeting addressed FDA's progress in implementing the 

various MDUFMA provisions, including the guidance documents FDA issued under the 

new law. The meeting gave stakeholders an opportunity to provide information and share 

their views on the implementation of MDUFMA. 

SMALL BUSINESS DETERMINATIONS (SBD) 

http://www.fda.gov/cdrh/mdufma/guidance/ 

Firms that qualify as MDUFMA small businesses are eligible to pay reduced fees for 

medical device applications that are subject to a user fee. In FY 2005 CDRH received, 

evaluated, and responded to 674 requests for Small Business Determinations under the 

meaning of MDUFMA, and granted 644, an increase of 13 percent over FY 2004. 

CDRH FY 2005 Annual Report 13
INCREASING ACCESS TO INNOVATIVE TECHNOLOGIES

MDUFMA PERFORMANCE 

CDRH made steady progress in developing and deploying process improvements in its 

medical device review program. The Center set milestones for measuring review 

progress more frequently and for tracking each PMA individually. Quarterly progress 

updates are available on the MDUFMA web site at 

http://www.fda.gov/cdrh/mdufma/index.html. 

TRAINING AND PROFESSIONAL DEVELOPMENT 

CDRH is committed to strengthening its workforce. CDRH’s Staff College provides 

employees with comprehensive professional and technical training through classroom 

training, live satellite teleconferences, web casts, online coursework, and a variety of 

seminars and lectures. In FY 2005 CDRH increased to 37 the number of technical 

science courses available to staff and improved its new employee training and reviewer 

training. In total, 852 employees enrolled in 153 different courses. The Center also made 

significant advances toward developing science, management and business competency 

models. 

GUIDANCE DEVELOPMENT 

http://www.fda.gov/cdrh/mdufma/guidance/ 

Guidance development facilitates interactions with industry and ensures effective 

program implementation. CDRH issued guidance documents on premarket approval 

applications, premarket assessment of pediatric medical devices, and premarket 

assessment and use of validation data for reprocessed single use devices. In total, CDRH 

issued 28 guidance documents in FY 2005. 

UTILIZING EXTERNAL EXPERTISE

CDRH ADVISORY COMMITTEES 

http://www.fda.gov/cdrh/panel/ 

CDRH held 17 Federal Advisory Committee panel meetings in 2005. These panels of 

external experts reviewed and made recommendations to FDA on 10 premarket approval 

(PMA) applications, one humanitarian device exemption (HDE), two premarket 

notifications (510(k)s), five pre-amendment device classifications, and six general issues. 

Among the topics addressed at the meetings were issues associated with significant 

breakthrough technologies for endovascular aortic repair, blood vessels connection, and 

hip joint resurfacing. 

CDRH FY 2005 Annual Report 14
INCREASING ACCESS TO INNOVATIVE TECHNOLOGIES

MEDICAL DEVICE FELLOWSHIP PROGRAM (MDFP) 

http://www.fda.gov/cdrh/mdfp/about.html 

CDRH established the Medical Device Fellowship Program (MDFP) to increase the 

range and depth of collaborations between CDRH and the outside scientific community. 

The MDFP offers short and long-term fellowship opportunities for individuals interested 

in learning about the regulatory process and sharing their knowledge and experience with 

medical devices from the relatively simple to the highly complex. In FY 2005 MDFP 

worked with National Research Council Associates Program on a Resident Research 

Associateship Program, and on a memorandum of understanding (MOU) with Duke 

University and Brigham and Women’s Hospital. MDFP programs provide doctoral 

scientists and engineers of unusual ability and promise or proven achievement with an 

opportunity to conduct research on problems which are compatible with CDRH research 

and review interest. 

By the end of FY 2005 CDRH had brought in 74 new experts under the Medical Device 

Fellowship Program (MDFP). These included engineers, medical officers, statisticians, 

scientists, project managers, consumer safety officers, and program support staff to 

increase CDRH’s scientific and technical capabilities. 

THIRD PARTY REVIEW PROGRAM 

http://www.fda.gov/cdrh/thirdparty/index.html

The Accredited Persons Program was created by the FDA Modernization Act of 1997 

(FDAMA), based on an FDA pilot. The purpose of the program is to improve the 

efficiency and timeliness of FDA's 510(k) process, the process by which most medical 

devices receive marketing clearance in the United States. Under the program, FDA has 

accredited third parties (Accredited Persons) that are authorized to conduct the primary 

review of 510(k)s for eligible devices. Persons who are required to submit 510(k)s for 

these devices may elect to contract with an Accredited Person and submit a 510(k) 

directly to the Accredited Person. The Accredited Person conducts the primary review of 

the 510(k), then forwards its review, recommendation, and the 510(k) to FDA. By law, 

FDA must issue a final determination within 30 days after receiving the recommendation 

of an Accredited Person. Submitters of 510(k)s who do not wish to use an Accredited 

Person may submit their 510(k)s directly to FDA. 

In FY 2005 FDA increased the use of the Third Party Review Program for 510(k) 

submissions. CDRH received 243 510(k) submissions, which were reviewed by third 

party organizations under the Accredited Persons provisions (section 523) of the Federal 

Food, Drug, and Cosmetic Act. The program realized a 27 percent increase since FY 

2003. The Center made final decisions on 251 third party 510(k) submissions, an 

increase from the 244 final decisions in FY 2004. CDRH continued to improve the 

quality and consistency of third party reviews and facilitate timely action on these 

submissions. In FY 2005 CDRH conducted a training session for FDA staff and for third 

party reviewers. In addition, telephone conferences with all third parties in January and 

April 2005 provided a routine forum for discussing issues and answering questions. 

CDRH FY 2005 Annual Report 15
INCREASING ACCESS TO INNOVATIVE TECHNOLOGIES

MAINTAINING THE QUALITY OF PREMARKET REVIEWS

CDRH QUALITY REVIEW PROGRAM 

CDRH’s quality review program for premarket submissions evaluates the quality of its 

scientific review. The program started by focusing on three key areas: 

• biocompatibility 

• sterilization 

• statistical analysis. 

The Center has initiated improvements in reviewer training in these areas, based on the 

findings of this program. Other review areas will soon be added to the program, 

including software and clinical protocol reviews. This on-going process will allow CDRH 

to improve the quality of its reviews in key scientific areas, thus ensuring that reviewers 

consistently ask the right questions at the right times.

CDRH FY 2005 Annual Report 16
IMPROVING PROBLEM DETECTION

CDRH is taking steps to increase its ability to identify, analyze, and act on postmarket 

information to improve the safety and effectiveness of medical devices and radiationemitting products. In FY 2005 the Center overtook a comprehensive inventory of its 

postmarket safety programs, made changes to the condition of approval program and in 

collaboration with the industry and professional association worked to improve adverse 

event detection and management. 

IMPROVING POSTMARKET SURVEILLANCE

MEDICAL DEVICE POSTMARKET TRANSFORMATION INITIATIVE 

http://www.fda.gov/cdrh/postmarket/mdpi.html

In FY 2005 CDRH overtook a comprehensive inventory of its postmarket safety 

programs, including recalls, MDR and MedSun. In each of these areas, the Center looked 

at its successes and challenges in implementing an effective program. The postmarket 

safety program inventory considered how the Center identifies postmarket problems, 

assesses the information obtained, and responds to that information through both 

stakeholder communication and enforcement action. The Center's plan to strengthen its 

postmarket program focuses on: developing a "culture of collaboration" for postmarket 

safety within the Center; developing world-class data sources and systems to quickly and 

accurately collect, analyze, and disseminate information about potential risks; enhancing 

risk communication efforts; and improving coordination with the FDA field staff. A 

senior-level team, comprised of CDRH management and outside consultants experienced 

in medical device safety and product regulation will help guide the Center in this effort. 

IMPROVING COORDINATION OF POST-APROVAL STUDIES 

The post-approval studies program involves the review, design and tracking of clinical 

studies that are required of manufacturers as a condition of approval of a PMA. In 

January 2005 CDRH transferred the coordination of the post-approval studies program to 

the Office of Device Evaluation to the Office of Surveillance and Biometrics. CDRH 

worked with sponsors design post-approval studies that answer important postmarket 

questions and are realistic and founded on good science, developed a guidance document 

for use by sponsors that specifies reporting requirements, and implemented a tracking 

system to ensure that studies are timely and accurate and provide useful results that are 

implemented into revised product labeling. 

CDRH FY 2005 Annual Report 17
IMPROVING PROBLEM DETECTION 

DEVELOPING A MEDICAL DEVICE ELECTRONIC ADVERSE EVENT REPORTING 

SYSTEM 

CDRH is developing an electronic adverse event reporting system that will facilitate 

processing the reports and reduce operating costs. In FY 2005 CDRH received, 

processed, analyzed and responded to about 180,000 medical device adverse events 

reported through CDRH’s Medical Device Reporting (MDR) system. This system 

uncovered many public health issues and problems ranging from orthodontic headgear, 

hemodialysis systems and hospital beds, to cochlear implants, deep brain stimulators, and 

diagnostic tests for heart attacks and pregnancy. 

USING TARGETED SURVEILLANCE: THE MEDSUN NETWORK 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/linkwarning/linkwarning.cfm?link=htt

ps%3A%2F%2Fwww%2Emedsun%2Enet%2Fabout%2Ehtml 

MedSun is CDRH’s response to a section of the Food and Drug Administration 

Modernization Act (FDAMA), which required FDA to move from a mandatory program 

to surveillance reporting by a subset of clinical facilities. The program’s principal 

objective is to increase both the quantity and quality of user facility reporting by 

recruiting a cadre of well-trained and motivated facilities, and to establish a collaborative 

effort to better understand medical device use in the clinical environment. By mid-2005 

MedSun expanded to approximately 350 health care institutions (mostly hospitals) 

nationwide. 

In addition to enhancing the detection of emerging device problems, the MedSun network 

acts as a two-way communication channel between the CDRH and the clinical 

community and serves as a setting for applied clinical research on device issues. To 

succeed, the effort must train participants in the recognition and reporting of adverse 

events, assure reporting confidentiality, minimize the burdens of participation, and 

provide timely feedback on safety information. 

FY 2005 efforts within the network, included: 

• MedSun’s Annual Conference 

• a survey on “single-use device” reprocessing 

• development of educational materials 

• implementation of the Device Safety Exchange Program (highlighting best safety 

practices and safety solutions) 

• monthly newsletters (highlighting device reports, CDRH actions, and other notable 

safety initiatives by other agencies) 

• clinical engineering audio-conferences 

• launching a pilot program for CBER. 

CDRH FY 2005 Annual Report 18
IMPROVING PROBLEM DETECTION 

MedSun’s FY 05 Annual Conference attendees participated in a workshop on infusion 

pump safety, and received training on problem recognition with laboratory devices and 

with pediatric devices. A survey evaluation of the current status of “single-use device” 

reprocessing in the MedSun clinical community was completed. Of the 53 sites 

participating in this survey, none were aware of any increase in tracked infections in their 

facility or any deaths or serious injuries associated with the use of reprocessed devices. 

CDRH developed and made available to MedSun sites educational materials addressing 

problem recognition and reporting for laboratory devices and devices used on the 

pediatric population. The Center implemented the Device Safety Exchange (DS-X) 

Program for online sharing of questions and device quality improvement ideas by 

MedSun reporting sites. The DS-X web site allows participants to submit questions and 

ideas directly to MedSun staff who review, edit and post them for view by all MedSun 

sites. Topics addressed this year included, policies and risks associated with cell phones 

in the hospital environment and cybersecurity. 

CDRH also launched a pilot program for CBER. The program will enable CBER to 

acquire information from MedSun sites on issues involving human cells and tissues. 

Engineering audio conferences on this development were provided to all MedSun sites. 

DETECTION OF ADVERSE MEDICAL DEVICE EVENTS WITH ELECTRONIC 

DISCHARGE RECORDS 

CDRH began several collaborations with the Agency for Healthcare Research and 

Quality, which administers several data sets of interest, including the Healthcare 

Utilization Project Nationwide Inpatient Sample (NIS) of hospital discharge claims and 

the State Inpatient Databases (SID) of hospital discharge claims. An interagency group 

used the NIS and SID to study short term health problems among those who had three 

types of hip prosthesis surgery: total hip replacement, partial hip replacement, and 

revision of an existing hip prosthesis. Although similar studies have been done with 

smaller patient groups, this is the first to use a national dataset to make national estimates 

of the short term outcomes of hip prosthesis surgery. A different team used the NIS data 

to estimate national numbers of discharges for specific diagnoses of device-related 

problems. This latter study is the first systematic description of the national burden of 

adverse medical device events using hospital discharge records. A third project, still in 

progress, is examining and comparing the data available in NIS and in the CDRH adverse 

event reports for automatic implantable cardioverter defibrillators. 

ACTIVE DEVICE SURVEILLANCE 

CDRH continued the contract with the University of Utah for Phase 2 of a pilot on active 

surveillance of medical device problems in hospitals. The new direct observation 

portion of the project is meant to establish a “gold standard” estimate of the number of 

device-related adverse events occurring in a hospital setting. The methodology is to note 

problems with device use as comprehensively as possible by directly observing patient 

care and actively soliciting information on adverse device events from as many sources 

CDRH FY 2005 Annual Report 19
IMPROVING PROBLEM DETECTION 

as feasible. This project builds on the pilot of active surveillance of medical device 

problems in hospitals. 

DATA MINING 

CDRH is contracting with Lincoln Technologies in using their web-based safety data 

mining environment called WebVDME to mine device adverse event data. This software 

has been used at CDER to study age/gender effects, to predict the safety profiles of 

proposed combination drugs, and to separate contributions of individual drugs to safety 

problems in poly-therapy situations. This tool may be a way to optimize evaluation 

resources and enhance CDRH’s ability to identify device-related safety concerns. The 

use of enhanced data mining techniques may improve upon CDRH’s current ability to 

identify adverse event patterns in postmarket safety databases. 

MINIMIZING USER-RELATED HAZARDS

HUMAN FACTORS AND LABELING 

http://www.fda.gov/cdrh/humanfactors/whatis.html 

Human factors (HF) is the study of how people use technology. It involves the interaction 

of human abilities, expectations, and limitations, with work environments, and system 

design. The term “human factors engineering” (HFE) refers to the application of human 

factors principles to the design of devices and systems. It is often interchanged with the 

terms "human engineering," "usability engineering," or "ergonomics." The goal of HFE 

is to design devices that users accept willingly and operate safely in realistic conditions. 

In medical applications, HFE helps improve human performance and reduce the risks 

associated with use error. 

CDRH’s human factors and labeling efforts help minimize use-related hazards, assure 

that intended users are able to use medical devices safely and effectively, and facilitate 

reviews of new device submissions. During FY 2005 the Center’s human factors and 

labeling activities included -- performing 84 labeling and 10 human factors reviews, 

working to apply eLabeling principles to 4 prototypes, and evaluating CDRH’s process 

for incorporating human factors principles into premarket review. 

CDRH FY 2005 Annual Report 20
IMPROVING PROBLEM DETECTION 

INTERNATIONAL PROGRAMS

GLOBAL HARMONIZATION 

This fiscal year, CDRH worked with foreign governments to facilitate international 

harmonization, specifically under the United States/European Community Mutual 

Recognition Agreement on transatlantic trade and the Global Harmonization Task Force 

(GHTF).1

The Medical Device Annex of the MRA covers the exchange of quality systems 

evaluation reports for all medical devices and premarket evaluation reports for selected 

low to medium risk devices. The Sixth Annual Report of the Medical Devices Annex to 

the U.S./EC Mutual Recognition Agreement (MRA), a joint report by the FDA, the 

National Institute of Standards and Technology (NIST) and the Commission for the 

European Communities (CEC) was issued December 2004. The report addressed the 

implementation of the Medical Devices Annex and contained accomplishments from 

December 1, 2003 to December 1, 2004. The report is available at 

http://www.fda.gov/cdrh/mra/annualreport2004.html. 

 In September 2005 FDA hosted a GHTF Joint Study Group Meeting. A Joint Study 

Group Meeting was held to facilitate cross-consultation and joint consideration of issues 

by the study groups and provide a forum to update the members on the activities of all of 

the study groups. 

 

1

 GHTF is an international voluntary group of representatives from national medical device regulatory 

authorities and the regulated industry. The United States is one of the five founding members of GHTF. 

Members are from the following three geographical areas: Asia, Europe, and North America. The purpose 

of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, 

effectiveness, performance and quality of medical devices; and promoting technological innovation and 

facilitating international trade. The primary way in which this is accomplished is via the publication and 

dissemination of harmonized guidance documents on basic regulatory practices. Study groups are 

responsible for the drafting of the harmonized guidance documents. 

CDRH FY 2005 Annual Report 21
IMPROVING COMMUNICATION OF 

MEDICAL TECHNOLOGY INFORMATION

In FY 2005 CDRH continued to improve communication by providing increased access 

to information on regulated products and health issues on its FDA web sites, in 

newsletters, through increased outreach efforts, and through internal operational 

initiatives. CDRH’s web sites offer new and in-depth information on how to get healthy 

and stay healthy. They also offer information on current CDRH activities to ensure that 

medical devices and radiation-emitting products are fit to use. 

INCREASING ACCESS TO INFORMATION ON REGULATED 

PRODUCTS AND HEALTH ISSUES 

MEDICAL DEVICE RECALL WEB SITE 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/med

icaldevicesafety/recalls.cfm 

In FY 05 CDRH redesigned the Medical Device Recall web 

site to provide a web-friendly, plain language overview of 

medical device recalls. The web site now explains the various 

classes of medical device recalls and the procedures that FDA 

and companies follow during a recall. The web site continues to describe each Class I 

recall in a plain language format and provides access to the new recall database. 

PUBLIC HEALTH NOTIFICATIONS 

http://www.fda.gov/cdrh/safety.html

Notices, available on the Public Health Notification web site, are 

issued to mitigate risk from medical device problems. FY 2005 

notifications covered issues such as: 

• Ralstonia bacteria contamination of a humidifier used in neonates 

• Recommendations for clinicians concerning the recalled Enterex implantable device 

for Gastroesophageal Reflux Disease (GERD) 

CDRH FY 2005 Annual Report 22
IMPROVING COMMUNICATION OF MEDICAL 

TECHNOLOGY INFORMATION

• Information about failures with the Guidant Implantable Cardioverter Defibrillator 

• Recommendations to avoid entrapment of vulnerable patients in the Vail bed. 

FDA PATIENT SAFETY NEWS (FDA PSN) 

http://www.fda.gov/cdrh/psn 

CDRH coordinated the agency production of FDA Patient 

Safety News, an award-winning monthly television news show 

and web site distributed to health care practitioners across the 

nation. FDA PSN covers a wide range of stories on medical 

errors, patient safety, recalls and alerts, and newly approved 

drugs, devices and biological products. The news show is a major agency vehicle for 

communicating FDA safety messages on medical products to physicians, nurses and 

pharmacists. The video feature of the program often improves the understanding of 

safety issues, particularly in circumstances such as identifying counterfeit drugs, 

demonstrating how medical errors occur, and depicting recalled products. Because of 

this, the video program is often used by risk managers and educators to train health care 

staff on the safe use of drugs, devices, and biologics. In FY 2005 the FDA PSN web site 

received about 8,500 “hits” per month, an increase of about 40 percent over the previous 

year. 

TOPIC-SPECIFIC WEB SITES 

CDRH developed and updated various topic-specific web pages, including those for 

breast implants and cochlear implants. These sites provide information about high 

interest topics, including newly approved and first-of-a-kind device technologies. 

Information in the sites includes questions to discuss with the doctor. Currently, there are 

eight sites, including a newly launched Phakic Intraocular Lenses web site 

(http://www.fda.gov/cdrh/phakic/). 

FDA & YOU 

www.fda.gov/cdrh/fdaandyou/index.html

Now in its second year of online publication, the FDA & You 

newsletter targets secondary school students and health 

educators. FDA & You provides information on FDA topics of 

interest to teenagers. 

CDRH FY 2005 Annual Report 23
IMPROVING COMMUNICATION OF MEDICAL 

TECHNOLOGY INFORMATION

EXPLORING WAYS TO IMPROVE ACCESS TO CDRH’S

INFORMATION

SMALL MANUFACTURERS, INTERNATIONAL AND CONSUMER ASSISTANCE 

http://www.fda.gov/cdrh/industry/support/ 

CDRH’s Division of Small Manufacturers, International and Consumer Assistance 

(DSMICA) was mandated by the 1976 medical device legislation to provide technical 

and regulatory assistance to small manufacturers and help them comply with Food and 

Drug Administration (FDA) requirements for medical devices. 

Through DSMICA and its Device Advice web site (http://www.fda.gov/cdrh/devadvice/), 

CDRH provides regulatory assistance to medical device manufacturers, consumers and 

foreign governments. CDRH provides manufacturers assistance with: 

• product classification 

• premarket and postmarket requirements 

• labeling 

• manufacturing requirements (quality system) 

• import/export issues for medical devices 

• reporting requirements for electronic products. 

Consumers can obtain information on medical devices and radiation-emitting products 

that help them enhance their ability to avoid risk, achieve maximum benefit, and make 

informed decisions about the use of medical devices and radiation-emitting products. 

CDRH also identifies and supports international and global harmonization activities, 

including educating foreign governments on the medical device regulatory process, and 

directing U.S. firms to sources of information on foreign requirements for medical 

devices. 

In FY 2005 CDRH continued providing assistance and outreach to help small 

manufacturers and international producers comply with FDA requirements for medical 

devices. CDRH answered 44,000 requests for information, 7,000 responses involving 

international activities, and distributed 82,000 guidance documents on inspection and 

enforcement procedures, product development, and regulatory submissions. CDRH’s 

outreach efforts took the Center to 47 domestic and international manufacturers’ 

meetings, conferences, and workshops. 

CDRH FY 2005 Annual Report 24
IMPROVING COMMUNICATION OF MEDICAL 

TECHNOLOGY INFORMATION

E-CONSUMER INITIATIVE 

NEW WEB FEATURES 

In FY 2005 several new features were added to the CDRH web site to offer users options 

regarding how they receive information about medical devices and radiation-emitting 

products information. New tools included: 

• Email subscription management system 

• Real Simple Syndication (RSS) feeds 

The email subscription service alerts customers when information of interest to them has 

been added or updated on the web sites. It allows users of the CDRH web site to create 

profiles of interest by subject area. RSS feeds deliver news directly to a user’s desktop. 

RSS is an XML-based format for sharing and distributing CDRH Web content, including 

new device approvals, recalls, and other news items. 

IMPROVING COMMUNICATION 

CDRH uses multiple tools to ensure efficient outreach efforts. In FY 2005 these tools 

included: 

• satisfaction surveys 

• program evaluations 

• web usability testing 

• unsolicited feedback (i.e., letters and phone calls) 

• conference participation 

• paper media (e.g., newsletters and brochures). 

In FY 2005, CDRH conducted an online survey of 1,006 CDRH web site users. CDRH 

asked user what they needed from its web sites and their satisfaction with the information 

available. This information will help CDRH improve the services it provides to the 

public. CDRH also participated in six professional and health educator conferences. At 

the conferences Center staff provided patient safety information and promoted CDRH 

communication programs. 

CDRH promoted the use of risk communication methodologies throughout the Center 

raising awareness about the importance of effective communication with internal and 

external groups. This was accomplished by providing training conducted by expert Risk 

Communicators and Center Staff. 

CDRH FY 2005 Annual Report 25
IMPROVING COMMUNICATION OF MEDICAL 

TECHNOLOGY INFORMATION

Various easy-to-read health brochures are available to the public through CDRH. This 

year the CDRH updated its Human Factors, Breast Implant, and Office of In Vitro 

Diagnostics (OIVD) brochures. These brochures are disseminated through various 

mechanisms including web, conferences, and professional and industry meetings. 

IMPROVING THE COMMUNICATION INFRASTRUCTURE

UNITING PRE AND POSTMARKET: CDRH DEFIBRILLATOR WORKING GROUP 

Established in FY 2005 the CDRH Defibrillator Working Group unites both premarket 

and postmarket working groups with the goal of disseminating relevant information 

regarding device approvals, adverse events, recalls and other pertinent issues. This 

working group is an example of the Center’s Total Product Life Cycle (TPLC) approach 

in that the information learned from the postmarket arena can then be used to support 

premarket reviews. 

INFORMATION TECHNOLOGY (IT) SOLUTIONS 

CDRH’s Information Management Steering Committee (IMSC), whose members are 

CDRH senior management, began working in FY 2005 towards ensuring that IT projects 

are consistent with Center strategic goals and priorities, and toward developing a 

meaningful CDRH IT Strategic Plan. In addition, CDRH began using project 

management plans, a performance measurement tool, to implement and monitor the 

progress of major IT projects. 

IT systems allow for better monitoring and tracking of premarket submissions and for 

improved communication and coordination among review teams. CDRH continued using 

the Center-level premarket tracking system to help monitor and manage CDRH workload 

to ensure that appropriate scientific expertise is used to review each document. In FY 05 

the Center began piloting the use of eRoom, a web-based collaboration tool, in support of 

Premarket Approval Application reviews. The software allows for real-time information 

sharing and communication among review team members and provides a central location 

for document storage and retrieval. Additional FY 2005 projects included: 

• tracking system for Conditions of Approval postmarket studies (COATS) 

• electronic consultations tracking (eConsult) 

• device nomenclature management system (DNMS) 

• enhancements to the system for the generation and electronic submittal of in vitro 

diagnostics (IVD) applications (Turbo510k) 

• program for accepting electronic premarket submissions (eCopy) 

• program for accepting and processing electronic adverse event reports (eMDR). 

CDRH FY 2005 Annual Report 26
IMPROVING COMMUNICATION OF MEDICAL 

TECHNOLOGY INFORMATION

COLLABORATING TO PROMOTE EFFECTIVE PUBLIC 

HEALTH COMMUNICATION

The Center’s top priority is to increase its ability to obtain critical information about 

medical device failures and to communicate this information clearly and rapidly to 

physicians and the public so they can use it to make sound, informed medical decisions. 

CDRH maintains cooperative relationships with professional societies and trade 

organizations to promote effective public health communication. These organizations 

include the American College of Cardiology; American Dental and American Diabetes 

Associations; American Association of Pediatrics; American College of Radiology; 

Conference of Radiation Control Program Directors; AdvaMed; Food and Drug Law 

Institute, and Medical Device Manufacturers Association. 

POLICY CONFERENCE ON IMPLANTABLE CARDIOVERTER DEFIBRILLATORS 

(ICDS) AND PACEMAKERS 

http://www.hrsonline.org/uploadDocs/HRS_Device-Performance-RecommendationsApr06.pdf 

The September 2005 Heart Rhythm Society (HRS) policy conference on implantable 

cardioverter defibrillators and pacemakers was a good step toward improving 

communications with clinicians, patients, industry representatives, and regulators. The 

purpose of the conference was to review the current process for recalls and to discuss the 

important elements of risk communication that can help guide physicians in treating 

patients with recalled defective devices. 

RETROSPECTIVE REVIEW OF PACEMAKERS AND IMPLANTABLE 

CARDIOVERTER DEFIBRILLATORS (ICDS) 

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01231.html 

As part of the agency’s ongoing commitment to improve the safety monitoring of ICDs 

and provide earlier notices to doctors and patients of potential problems, FDA announced 

its retrospective review (initiated in 2003) of ICD’s and pacemakers malfunctions. 

FDA’s findings were released at the September 16, 2005 Heart Rhythm Society (HRS) 

Policy Conference in Washington, DC. 

CDRH FY 2005 Annual Report 27
IMPROVING COMMUNICATION OF MEDICAL 

TECHNOLOGY INFORMATION

PROMOTING THE SAFE USE OF INFUSION PUMPS 

http://www.fda.gov/cdrh/cdrhhhc/ The CDRH Home Health Care Committee is tasked 

with reviewing what the Center does to address problems when devices are used in the 

home and recommending further Center actions to assure that devices are being used 

safely and effectively in the home environment. In FY 05 CDRH continued its efforts to 

address the needs of the growing number of patients using clinical medical devices in this 

environment. The Center developed an outreach strategy to promote the safe use of 

infusion pumps. The Center asked manufacturers of infusion pumps to submit 

instructions for use and basic pump information for every pump marketed during or after 

1984. With this information, the Center developed a prototype electronic repository of 

manufacturers’ infusion pump labels containing pump information and instructions for 

use. The repository is under review and CDRH continues to receive information from 

manufacturers. Once collected, the label information will become part of CDRH’s 

publicly accessible home health care device web site. Label availability will increase the 

likelihood that patients, the families and health care providers will have continuous 

access to pump information and instructions, helping to ensure safe and effective home 

use. 

EDUCATING HEALTH PROFESIONALS: TROPONIN 

http://www.fda.gov/cdrh/oivd/labsafetytips.html#tip10

The laboratory safety tip was posted by the Office of In Vitro Diagnostic Device 

Evaluation and Safety (OIVD) on its web page. It is a follow-up to a signal identified 

from MDR reports and literature on falsely elevated results for Troponin, an indicator test 

for heart attack. CDRH worked with industry to address this educational need. 

AdvaMed, a trade association representing medical device manufacturers, drafted the tip 

in response to concerns about this issue expressed by FDA. 

BUILDING QUALITY INTO DEVICE CLINICAL TRIALS WORKSHOP 

In FY 2005, the CDRH Bioresearch Monitoring Group collaborated with the Food and 

Drug Law Institute (FDLI) to improve the quality of device clinical trials by using a 

“Best Practices” approach. CDRH developed and presented a workshop for the domestic 

and international industry entitled “Integrating Quality into Device Clinical Trials”. The 

telecast reached 115 US and international sites with approximately 1000 attendees. 

510(K) WORKSHOP FOR NEW MANUFACTURERS 

CDRH worked collaboratively with members of industry to host a workshop on 510(k) 

submissions at the annual meeting of the Association of Medical Device Manufacturers. 

The workshop helped companies new to the in vitro diagnostics industry learn how to 

develop and submit high quality 510(k) submissions. Both CDRH and industry believe 

that helping companies understand good trial design and how to develop submissions 

CDRH FY 2005 Annual Report 28
IMPROVING COMMUNICATION OF MEDICAL 

TECHNOLOGY INFORMATION

conforming to CDRH administrative and scientific requirements will produce more 

reliable and rapid reviews which will benefit device manufacturers and the public. 

FDA MEDICAL DEVICE WORKSHOP 

In September 2005 CDRH and FDA Los Angeles District Office conducted a FDA 

medical device three workshops in Los Angeles, CA. The three-day event consisted of a 

one-day workshop each day. The three topics addressed were: 

• Premarket Requirements 

• Quality System Requirements 

• CDRH’s Office of In Vitro Diagnostic Device (OIVD) Evaluation and Safety. 

•

• Over 4,000 FDA registered establishments in the Los Angeles district were invited to 

attend these workshops. Registration is limited to 200 attendees per workshop-day. 

There was no registration fee for attendees to these workshops. 

WORKSHOP ON DRUG-DIAGNOSTICS TRANSLATIONAL RESEARCH 

The new field of pharmacogenetic research will enable pharmaceutical companies to 

develop drug treatments that precisely target the needs of particular patient populations. 

By linking drug treatments to diagnostic tests that can accurately identify appropriate 

receptive patients, pharmaceutical companies aim to decrease drug adverse events, 

increase drug response rates, and ultimately save healthcare dollars. In April 2005 

CDRH held the third in a series of national workshops on drug and diagnostic codevelopment. The workshop gave stakeholders a public venue for scientific suggestions 

and concerns about FDA regulatory practices in this important and growing new area. 

CDRH is using the proceedings of this conference to develop guidance to ensure that this 

research translates in a rapid and cost-effective manner to new joint products that can 

quickly enter the medical marketplace. 

CDRH FY 2005 Annual Report 29
USING RISK INFORMATION TO 

PROTECT THE PUBLIC

PROTECTING HUMAN RESEARCH SUBJECTS AND 

CONFRONTING RESEARCH MISCONDUCT

The Bioresearch Monitoring (BIMO) program is entrusted with protecting the rights, 

safety, and welfare of human research subjects and insuring the quality and integrity of 

device research. 

APPLICATION OF INTEGRITY POLICY 

Implementation of FDA's Application Integrity Policy involves investigations of sponsors 

that are suspected of submitting false or misleading data to the FDA. It also includes the 

review, evaluation, and monitoring of validity assessments required to be completed by 

sponsors found guilty of fraudulent activities. In FY 2005 CDRH invoked the 

Application Integrity Policy (AIP) against a manufacturer and a distributor of drugs of 

abuse test kits. This action effectively removed thousands of potentially inaccurate and 

ineffective diagnostic drugs of abuse test kits from the marketplace. Because of this 

action, CDRH suspended the substantive review of eight of the manufacturer’s pending 

510(k) marketing submissions, and the manufacturer subsequently withdrew 18 

additional cleared 510(k) marketing submissions due to widespread data inconsistencies 

and questionable design and research practices. 

REMOVAL FROM THE APPLICATION INTEGRITY POLICY LIST AND THE 

INTEGRITY HOLD LIST 

The Application Integrity Policy is invoked in cases where unreliable safety or 

effectiveness data is uncovered in numerous applications currently under FDA review 

and evaluation while the Integrity Hold is invoked when questionable data is uncovered 

in only one application under FDA review. In FY 2005, CDRH removed one sponsor 

from the AIP list and three sponsors from the integrity hold list. Removal from both lists 

are based upon the sponsor’s successful implementation of a corrective action plan that 

addresses shortcomings in the oversight of device research and assures higher quality 

marketing submissions. 

CDRH FY 2005 Annual Report 30
USING RISK INFORMATION TO PROTECT THE PUBLIC

NOTICE OF INITIATION OF DISQUALIFICATION PROCEEDING AND 

OPPORTUNITY TO EXPLAIN LETTERS (NIDPOE) 

A NIDPOE letter informs the recipient clinical investigator that FDA is initiating an 

administrative proceeding to determine whether the clinical investigator should be 

disqualified from receiving investigational products pursuant to the Food and Drug 

Administration's regulations. Generally, FDA issues a NIDPOE letter when it believes it 

has evidence that the clinical investigator repeatedly or deliberately violated FDA's 

regulations governing the proper conduct of clinical studies involving investigational 

products or submitted false information to the sponsor. In FY 2005 CDRH issued two 

NIDPOE letters to clinical investigators, one of which resulted in a restricted agreement 

between the Agency and the clinical investigator. 

INSTITUTIONAL REVIEW BOARDS (IRBS) FAILURE TO IMPLEMENT 

CORRECTIVE ACTIONS RESULTED IN FDA WITHHOLDING APPORVAL OF NEW 

STUDIES 

In FY 2005 CDRH issued Warning Letters to two IRBs for continuing to fail to comply 

with FDA regulations applicable to IRBs. The Warning Letters were issued following 

inspections whose purpose was to determine if the IRBs had implemented corrective 

actions assured in their response to previous Warning Letters and to determine if the 

IRBs were presently functioning in compliance with applicable FDA regulations. The 

Warning Letters requested that the IRBs take immediate action to correct the violations. 

Furthermore, the Warning Letters notified the IRBs that as a continued result of their 

noncompliance, FDA would withhold approval of new studies reviewed by the IRBs, and 

that no new subjects could be admitted to ongoing studies that were currently under 

review by the IRBs. These restrictions would remain in effect until the FDA notified 

them in writing that their corrective actions were satisfactory. 

CDRH BIMO INSPECTIONS 

Fiscal Years 2001- 2005 

Inspected Entity 2001 2002 2004 2005 

Sponsor 50 72 73 70 

CI 122 151 183 183 

IRB 40 128 73 48 

GLP 2 6 19 31 

CDRH FY 2005 Annual Report 31
USING RISK INFORMATION TO PROTECT THE PUBLIC

Figure 1. BIMO Warning Letters by Year 

14

44

30

9

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Figure 2. BIMO Warning Letters by Year and Type 

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CI Sponsor IRB GLP

CDRH FY 2005 Annual Report 32
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IMPROVING PRODUCT QUALITY AND SAFETY THROUGH 

BETTER MANUFACTURING OVERSIGHT

DEVELOPING A COMPLIANCE AND ENFORCEMENT TRACKING SYSTEM 

In FY 2005 CDRH’s Office of Compliance developed and received approval for the 

Vision Document, the initial phase in developing the compliance and enforcement 

component to the Center Tracking system (CTS), a work flow and work management 

system. The new CTS component will provide better tracking of regulatory actions and 

their outcomes. CDRH also participated in the requirements analysis for new and 

improved agency IT systems that will ensure that data collected will be meaningful and 

provide the data necessary for distributing resources and making risk-based prioritization 

schemes. 

PROTECTING THE PUBLIC 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cf

m 

CDRH completed several administrative and judicial actions to protect the American 

public. In FY 05, CDRH processed: 

• 182 warning letters

• 571 product recalls, including 25 highest-risk Class I, 423 Class II, and 123 Class III 

recalls 

PRIORITIZING COMPLIANCE-RELATED ACTIVITIES

CDRH continued to formulate a risk-based management program for inspection and 

enforcement actions. This process improves the decisions CDRH makes in regulating 

and monitoring the medical device industry. It not only impacts how inspections are 

prioritized, but will help to identify and prioritize other types of regulatory activities, 

such as device recalls, that present the greatest risk to public health. 

RISK-BASEB INSPECTION WORK-PLAN AND REGULATORY ACTIONS 

In FY 2005 CDRH continued using the inclusive risk-based inspection work plan 

process. This process ensures that all Center program offices have an opportunity to 

provide input into the prioritization of special emphasis inspections. 

In addition, CDRH analyzed 132 Warning Letters previously issued to medical device 

manufacturers. In the analysis, CDRH found that 75 percent of the citations related to 

CDRH FY 2005 Annual Report 33
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GMP violations and 24 percent related to MDR violations. This information also helped 

making decisions on inspection priorities and regulatory actions. 

EXCEEDING YEARLY INSPECTION GOALS 

CDRH coordinated with the Office of Regulatory Affairs (ORA) and provided technical 

support, as necessary, for inspections. In FY 2005 FDA surpassed all CDRH fiscal year 

inspection goals. FDA conducted: 

• 1,265 inspections of registered domestic Class II and Class III medical device 

manufacturers, exceeding the goal of the goal of 20 percent of the 5,520 registered 

manufactures 

• 230 foreign inspections, exceeding the goal of 7 percent of 2,500 registered foreign 

Class II and Class III medical device manufacturers 

• 335 BIMO inspections with an emphasis on scientific misconduct, data integrity, 

innovative products, and vulnerable populations, again exceeding its goal of 295 

domestic and foreign BIMO inspections. 

CLINICAL LABORATORIES IMPROVEMENTS ACT (CLIA) 

CLIA established quality standards for all laboratory testing to ensure accurate, reliable 

and timely patient test results regardless of where a test was performed. Of central 

importance to the CLIA program is the assignment of a complexity category to 

commercially marketed diagnostic tests. The tests are categorized into one of three CLIA 

regulatory categories based on their complexity (i.e., potential risk to public health) and 

laboratories may only purchase and use a particular test based on the laboratory’s level of 

CLIA certification. 

STREAMLINING THE CLIA APPLICATION PROCESSS 

Since CDRH reviews the premarket applications for these tests, streamlining the CLIA 

application process necessitates a transfer of responsibility for complexity determinations 

from the Center for Disease Control and Prevention (CDC) to FDA. During 2004 FDA 

completed the delegation of authority to FDA (CDRH) for CLIA complexity 

determinations and finalized a 5-year Interagency Agreement with the Centers for 

Medicare and Medicaid Services (CMS) for CLIA waiver authority. In 2005 FDA 

published draft guidance for the waiver process. The agency is reviewing the comments 

received in response to the guidance. 

CDRH FY 2005 Annual Report 34
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MAMMOGRAPHY QUALITY STANDARDS ACT (MQSA)

MQSA FACILITY INSPECTIONS 

CDRH conducted annual inspections of over 9,000 mammography facilities nationwide. 

The Center ensured that 98 percent of mammography facilities met inspection standards. 

Less than 2 percent of the facilities inspected had level 1 problems. CDRH worked with 

each of those facilities to assure adequate corrective action is taken. 

10 YEARS OF MQSA INSPECTIONS 

In FY 2005 CDRH commemorated 10 years of MQSA inspections. So far, MQSA 

inspectors have completed 93,000 facility inspections nationwide. The percent of 

inspections without adverse observations has more than doubled in that time, and the 

trend continues to rise. 

RADIATION SAFETY

RADIOLOGICAL HEALTH IMPLEMENTATION PROGRAM 

The CDRH Radiological Health Implementation Program Core Group was commissioned 

in Spring 2005 to consider all previous radiation health program studies and make 

recommendations for the program's future. Radiological Health activities are critical to 

providing expertise for the review and approval of treatment and therapy systems, for the 

prevention of excessive radiation exposures from diagnostics examinations such as 

fluoroscopy, and for monitoring and evaluation of radiation emitting products such as 

security screening devices. The recommendations are included in a report titled, “The 

CDRH Radiological Health Program - Adapting to Current Public Health Needs - 2005–

2010,” available at http://www.fda.gov/cdrh/radhlth/initiative.html. The new direction of 

the radiological health program will increase its relevance to, and impact on, the most 

pressing current public health problems in the radiological health arena and anticipate the 

evolution of medical radiation systems. FY 2006 efforts will shift to implementing the 

recommendations. 

REDUCING UNNECESSARY EXPOSURE FROM SOURCES REGULATED BY FDA 

In the Fall of 2005 CDRH held a meeting to provide a wide range of organizations 

involved in radiological health an opportunity for dialogue about collective efforts to 

reduce unnecessary exposure from sources regulated by FDA. 

CDRH FY 2005 Annual Report 35
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AMENDING GLOBAL LASER REGULATION 

CDRH proposed amendments to the Federal Laser Performance Standards, 21 CFR 

1040.10 and 1040.100, which adopt by reference and with national exceptions the 

International Electrotechnical Commission (IEC) laser standards as the new Federal 

standard. The amendments move to create a single global regulatory environment for 

laser product manufacturers, reducing the regulatory burden on industry and updating the 

Federal standard to reflect current laser technology and bioeffects research. 

NEW TECHNICAL STANDARDS FOR FLUOROSCOPY EQUIPMENT 

CDRH promulgated amendments to the Federal radiation-safety standard improving the 

performance of diagnostic x-ray systems and their major components. The amended 

technical standards, published as a final rule in the Federal Register on June 10, 2005, 

will require a number of new equipment features that will significantly reduce 

unnecessary exposure to x-rays, especially in fluoroscopy, while maintaining the level of 

image quality requisite for diagnostic efficacy. All fluoroscopic equipment manufactured 

on or after June 10, 2006, will be required to display values of the rate, duration, and 

cumulative amount of radiation emissions, thereby enabling a fluoroscopist to adjust 

techniques in real time to reduce patient exposure. Over the decade following 

implementation of this final rule, the expected improvement in the quality of health care 

is projected to reduce the annual U.S. population dose by more than 7,000 personsievert.2

 The dose reduction could decrease annual cancer deaths by over 200 and create 

annual savings of over $300 million. 

PROMOTING DEVELOPMENT OF CONSISTENT POLICIES ON REDUCING 

EXPOSURE TO THE GENERAL PUBLIC 

CDRH served on the Interagency Steering Committee on Radiation Standards (ISCOR), 

and in this capacity, promoted development of consistent policies on reducing exposure 

to the general public. Efforts included recommendations for appropriate use of security 

products and medical imaging equipment that exposes the public to ionizing radiation. 

2

 A sievert (Sv) is a unit of radiation dose equivalent. It replaces the rem (1 Sv equals 100 rem). Some types 

of radiation do more damage than others for the same absorbed dose – for example, an absorbed dose of 

alpha radiation causes 20 times as much biological damage as the same dose of beta radiation. The 

equivalent dose in sieverts is equal to the absorbed dose of radiation in grays multiplied by the relative 

biological effectiveness. 

CDRH FY 2005 Annual Report 36
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ASSESSING THE IMPACT OF LEGAL AND ILLEGAL USE OF RADIATIONEMITTING PRODUCTS 

CDRH performed an assessment of the impact of legal and illegal use of radiationemitting products in response to reports of green lasers directed at aircraft with the intent 

of distracting or temporarily flash-blinding the crew. FDA briefed House Science 

Committee staff in January 2005 on its authorities regarding the manufacture and use of 

laser products. FDA worked with the Federal Aviation Administration (FAA), 

Department of Homeland Security (DHS) and Department of Defense (DoD) to address 

this problem by providing technical consults in developing aircraft and pilot protective 

measures. FDA published and contributed to public information regarding safe use of 

laser pointers and cautioned against internet sales of laser products through various print 

media outlets and on the Internet. FDA took action against firms that sell modified green 

lasers that emit radiation in excess of the limit for general public use. 

RADIOLOGICAL HEALTH CIVIL MONEY PENALTY ASSESSED AGAINST A 

MANUFACTURER OF TELEVISION PRODUCTS 

In FY 2005 ADI Corporation agreed to pay the second installment of the Radiological 

Health Civil Money Penalty consent decree for $200,000 by August 2005. The total fine 

of $475,000 was filed against ADI in May 2003 for unlawful importation of certified 

television products when the ADI quality control testing program was disapproved. This 

was the first Radiological Health Civil Money Penalty assessed against a manufacturer of 

television products. 

EXPANDING PATIENT PROTECTION THROUGH APPLIED 

RESEARCH

CDRH research contributes to the internal review process as well as to the development 

of guidance for industry in the development of innovative technologies. FY 2005 areas 

of activity included: 

• Device safety in Magnetic Resonance Imaging (MRI) environments 

• Expiration date for medical gloves 

• Mechanical strength of vertebrae following injections with bone glue 

• Exposure to electromagnetic fields and its effects on implanted devices 

• Effectiveness and safety of Intraocular lenses (IOLs) 

• Combined approach to evaluate circulatory assist devices 

• Effects of optical energy 

• Device-tissue interfaces 

• Better animal models and improved biomarkers 

CDRH FY 2005 Annual Report 37
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• Reuse of single use devices 

• Drug eluting stents 

• Modeling to propose design changes to left ventricular assist device 

• Computer assisted diagnostic systems 

• Performance testing of pulse oximeters 

• Test methods for high intensity focused ultrasound 

• CDRH standards program 

DEVICE SAFETY IN MAGNETIC RESONANCE IMAGING (MRI) ENVIRONMENTS 

CDRH developed a new standard practice for marking medical devices and other items 

safe in the Magnetic Resonance environment. The revised system replaced the old 

system whose confusing MRI compatible terminology may have resulted in patient 

injuries. 

EXPIRATION DATE FOR MEDICAL GLOVES 

CDRH developed and validated a method for assigning an accurate expiration date for 

medical gloves. This work is critical to protect patients as well as health care workers 

from the transmission of infectious diseases or agents used in terrorist activities. 

MECHANICAL STRENGTH OF VERTEBRAE FOLLOWING INJECTIONS WITH 

BONE GLUE 

CDRH conducted research on the improvement in mechanical strength of vertebrae 

following injections with bone glue. This has become the most common treatment for 

compression fractures, a condition estimated to eventually affect a quarter of all women 

over the age of 50. The findings showed that the procedure can be effective if the bone 

density has not dropped too low. 

EXPOSURE TO ELECTROMAGNETIC FIELDS AND ITS EFFECTS ON IMPLANTED 

DEVICES 

CDRH measured and modeled exposure to electromagnetic fields and the effects on 

implanted devices from hand held and walk through security systems, cellular telephones, 

hand-held computers, and MRI systems. This research included models of the head for 

evaluation of cell phone exposure and of pregnant woman models for 9 gestational ages 

of the fetus for heating during MRI. This effort resulted in the standardization of specific 

absorption rate (SAR) across multiple systems. Results of this work include: 

• Five journal articles and 14 proceedings and other presentations during the past year 

• support from the FAA/TSA (for the security system studies) 

• establishment of a CRADA to further the virtual family modeling 

• participation in CDRH’s Epidemiology Grand Rounds on wireless medical devices 

CDRH FY 2005 Annual Report 38
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Modeling of the heating effects of MRI upon implanted pacemakers, ICDs, neural 

stimulators, and cardiac stents helped define the parameters for acceptable application of 

MRI for individuals with these implanted medical devices and has a potentially large 

impact on public health. 

EFFECTIVENESS AND SAFETY OF INTRAOCULAR LENSES (IOLS) 

CDRH developed a significantly more accurate and applicable confocal laser method for 

testing (IOL) diopter power. Precise measurement is critical for evaluating the 

effectiveness and safety of IOLs, which are implanted during cataract surgery. The test 

method has been used to evaluate samples of new IOL designs and on IOLs on regulatory 

hold because of questions about the labeled power. This work resulted in a pending 

patent, more than 10 proceedings publications and presentations during the past year, and 

has been submitted to Nature Methods. 

COMBINED APPROACH TO EVALUATE CIRCULATORY ASSIST DEVICES 

CDRH developed a combined approach of review and laboratory expertise to evaluate 

proposed ‘subtle’ design changes to critical components of life-sustaining mechanical 

circulatory assist devices. Design of the blood path in these devices is critical for 

avoiding damage to blood components, stroke, and embolism. CDRH’s new combined 

approach for review significantly reduces the review burden while reducing the 

uncertainty of the evaluations. 

EFFECTS OF OPTICAL ENERGY 

CDRH evaluated the effects of optical energy on cellular and intracellular structures and 

components. This resulted in improved understanding of the effects of light on energy 

production in cells. CDRH developed a new confocal fiber-optic nano-biosensing system 

that enables measurements at resolutions better than the theoretical half wavelength limit, 

resulting in work below the 200 nanometer range. This work, supported in part by an 

interagency agreement with the Air Force Office of Scientific Research, resulted in four 

journal articles, numerous proceedings and presentations during the past year, and a 

proposal to the Army’s Telemedicine and Advanced Technologies Research Center to 

evaluate optical methods of stimulation that may enhance the field of neuro-prostheses. 

DEVICE-TISSUE INTERFACES 

CDRH also worked towards developing a better understanding of the device-tissue 

interface for optical spectroscopy leading to improvements in the efficiency of 

spectroscopic methods for minimally invasive disease detection. This area has the 

potential to improve the detection of mucosal cancers and the monitoring of changes 

following therapeutic applications. This work resulted in two journal articles and five 

proceedings published during the past year. 

CDRH FY 2005 Annual Report 39
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BETTER ANIMAL MODELS AND BIOMARKERS TO IMPROVE PUBLIC HEALTH 

CDRH conducted research to stimulate the development of new evaluation tools - 

biomarkers and clinically-relevant preclinical models - for assessing the safety and 

efficacy of new medical products. An animal model of subclinical renal insufficiency 

that was able to detect known nephrotoxicants at doses that were non-toxic in “healthy” 

control animals was developed and partially validated. The regulatory impact is 

significant in that adverse effects detected using the disease model would have been 

missed using healthy animal models typically used to test medical devices. CDRH also 

evaluated a new kidney toxicity biomarker, kidney injury molecule that can be measured 

in kidney tissue and urine, and appears to be more sensitive for renal injury detection than 

traditional clinical markers. The public health impact is significant in that the new 

biomarker may be useful to identify patients with subtle renal disease at an earlier stage 

and prevent pathogenesis of renal failure as well as reduce uncertainties in the preclinical 

assessment of FDA-regulated products. 

INFECTION CONTROL: REUSE OF SINGLE USE DEVICES AND CLEANING 

VALIDATION 

CDRH conducted research to develop and validate cleaning and disinfection/sterilization 

methods to insure no microbial contamination, misdiagnosis due to tissue contamination, 

and toxicity resulting from residual detergents and disinfection/sterilization agents 

remaining on the device. CDRH has determined that total organic carbon is an effective 

marker of residual soil from patients exposed to the devices and residual chemicals used 

in reprocessing on cleaned devices versus measuring total protein only as an endpoint of 

cleaning. The research will improve safety of patients exposed to single-use and 

reuseable medical devices. Protein residual data from CDRH research have provided an 

endpoint for device reprocessors to meet requirements of supplemental validation 

submissions for single-use devices, and aided CDRH reviews and inspection functions. 

DRUG COATED STENTS: DRUG ELUTING STENTS ASSOCIATED THROMBOSIS 

The drug eluting stents have been shown to exhibit late-stent thrombosis which may be 

mediated by an increased expression of tissue factor (TF) and decreased levels of 

thrombomodulin in endothelial cells that line the arteries. CDRH research on the 

treatment of endothelial cells with either rapamycin or paclitaxel resulted in a slight 

increase in coagulation activity. However, addition of VEGF significantly augmented the 

coagulation cascade. Coagulation correlated with increased expression of TF in 

endothelial cells. Thrombomodulin expression was unaffected by either rapamycin or 

paclitaxel in the presence of VEGF. Data suggest that platelets and rapamycin/taxol may 

elevate TF expression. However, platelets themselves are not affected by either drug. 

These results suggest that anti-proliferative drugs exhibit prothrombotic effects which 

could be potentiated by VEGF. These findings imply that high levels of VEGF in 

atherosclerotic plaques could potentially contribute to thrombotic effects observed 

following drug eluting stent implants. 

CDRH FY 2005 Annual Report 40
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COMPUTATIONAL FLUID DYNAMICS OF LEFT VENTRICULAR ASSIST DEVICE 

CDRH laboratory conducted a study to aid in the evaluation of a post-approval study 

change for a pediatric left ventricular assist device (LVAD). The sponsor proposed to 

make a change to the blood flow path within the pump that could have adversely affected 

hemolysis and thrombogenesis in the pump such that patient safety and/or device efficacy 

could have been compromised. It would have been extremely difficult, if not impossible, 

to validate the design changes using animal or human data. After discussions and a 

meeting with FDA staff, the sponsor agreed to provide experimental (flow visualization, 

hemolysis) and analytical (computational fluid dynamics [CFD]) testing to support the 

design changes. CDRH experts recommended appropriate CFD models to the sponsors 

and analyzed the results. 

COMPUTER-ASSISTED DIAGNOSTIC SYSTEMS 

CDRH scientists have also played a leading role in the development of new models and 

methods for the assessment of computer-assisted diagnostic systems. The techniques 

were first developed during our review of digital mammography systems, and have since 

been extended to the development of systems for breast cancer screening, lung cancer 

screening, and CT colonoscopy. Having these tools and methods available has greatly 

assisted developers of these innovative imaging and CAD-assist devices. 

PERFORMANCE TESTING OF PULSE OXIMETERS 

CDRH scientists and engineers have developed test methods for a range of non-invasive 

monitoring devices. CDRH laboratory studies on pulse oximeter performance, for 

example, enabled substantial improvements in the ISO/IEC standard and the CDRH 

Guidance Document. This testing facilitated the development of a single test protocol for 

SpO2 accuracy studies, which simplified the premarket evaluation process by unifying 

the basis for establishing substantial equivalence. The work has established the 

groundwork to enable the extensions of claims being made for perfusion measurements 

and established acceptable performance criteria. 

TEST METHODS FOR HIGH INTENSITY FOCUSED ULTRASOUND 

The lack of standardized methods to assess the acoustic and thermal characteristics of the 

focused beams has challenged the regulatory review of these devices, especially in the 

pre-clinical phase, and has been burdensome to the industry. In the past CDRH scientists 

and engineers have developed measurement instrumentation and computational modeling 

techniques for characterizing other types of medical ultrasound devices such as 

diagnostic imaging and therapeutic ultrasound, and this work has resulted in the creation 

of numerous regulatory guidance and standards documents. This expertise is being used 

to accelerate the review of submissions for HIFU devices. For example, in a device for 

the ablation of uterine fibroids, CDRH-developed computational modeling was used to 

CDRH FY 2005 Annual Report 41
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predict the performance of the device under conditions that would have been difficult to 

investigate experimentally, thus shortening the review time. 

CDRH STANDARDS PROGRAM 

The Standards Management Staff develops and manages the standards used for 

regulatory assessments. The standards staff facilitates the participation of CDRH and 

other FDA staff in developing standards. In addition, SMS increases the recognition of 

voluntary consensus standards for medical devices and radiation-emitting electronic 

products. As part of this responsibility, the staff publishes lists of recognized standards 

annually and consistently increases the list of available standards. In 2005, CDRH 

recognized 48 new standards; and in addition, 110 standards were withdrawn and 

replaced by new versions, incorporated 98 changes to the existing recognized standards, 

and 14 standards were withdrawn. 

REGULATIONS AND GUIDANCE DEVELOPMENT

CDRH’s guidance information is available at http://www.fda.gov/cdrh/guidance.html. 

In 2005 CDRH worked to streamline guidance development. Center efforts included: 

• prioritizing its guidance workload 

• establishing performance goals 

• developing and implementing tracking mechanisms 

• engaging industry stakeholders in the early stages of guidance development 

• increasing the use of contract experts. 

CDRH issued 28 guidance documents and accomplished its performance goals. Among 

these documents were four draft guidance documents; several device-specific and special 

control guidance documents, including a guidance for intravascular stents and a guidance 

providing clarity on indications for implanted cardioverter defibrillators; and two key 

cross-cutting guidance documents - Software used in Medical Devices and Format and 

Content of 510(k) submissions. The latter document will assist manufacturers in the 

preparation of 510(k) submissions and should lead to more efficient and timely reviews. 

CDRH also worked with the Office of General Counsel and the Office of Policy 

Regulation editorial staff to review and revise the boilerplate Guidance Development 

Templates for all guidance documents. These templates are available to Center staff on 

the Center’s intranet web site. 

CDRH FY 2005 Annual Report 42
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In FY 05, CDRH’s guidance and regulation staff responded to nine citizen petitions and 

published sixteen final rules and forty-seven notices. 

 

CDRH FY 2005 Annual Report 43
PREPARING AND RESPONDING TO 

EMERGENCIES

CDRH made significant progress in this area. The Center routinely consulted with other 

government agencies on diagnostic and monitoring devices, radiological counter 

measures and radiation-emitting devices with potential to be used as weapons (e.g., 

visible lasers) and on radiation safety issues, including preventing unnecessary 

radiological exposure from security screening products. 

CDRH formed a technical work group to address the use and rapid approval of 

diagnostics issues related to influenza and assisted CDC in making available to the 

laboratory response network CDC’s rapid diagnostic test. 

RESPONDING TO HURRICANE KATRINA 

In September 2005, as a response to the Hurricane Katrina emergency, CDRH began 

posting hurricane and emergency-related information in its web site, available at 

http://www.fda.gov/cdrh/emergency/index.html. CDRH’s web site includes information 

about: 

• Disposal of Contaminated Devices 

• FDA Offers Advice About Reopening Dialysis Centers After Restoration of Power 

and Water 

• Natural Disasters - Effects on Mammography Facilities 

• FDA Offers Tips about Medical Devices and Hurricane Disasters 

• FDA Advice for Medical Devices that Require Refrigeration 

• FDA Advice About Medical Devices that Have Been Exposed to High Heat and 

Humidity 

• FDA Health and Safety Tips After Hurricanes for Food, Drugs, Biologic Products, 

and Animal Health

CDRH FY 2005 Annual Report 44
PREPARING AND RESPONDING TO EMERGENCIES

CONTINUATION OF OPERATIONAL PLANNING (COOP) 

The Center conducted COOP activities, participated in emergency preparedness 

exercises, and maintained the database of medical and in vitro diagnostic devices. The 

database allows quick identification of device manufacturers and available inventories to 

facilitate identifying potential shortages in medical and in vitro diagnostic devices that 

may be needed by emergency health care personnel in the acute phase of an emergency 

or disaster. 

CDRH posted information on cleared and approved devices for personal protection on its 

emergency information web site, www.fda.gov/cdrh/emergency/flu_qa.html. These 

devices are integral to minimizing the spread of infectious agents, including those used in 

bioterrorism. 

CDRH FY 2005 Annual Report 45
OBTAINING INFORMATION

ANNUAL REPORTS

CDRH Offices and its Ombudsman publish annual reports. These documents are 

available on the CDRH web site. A comprehensive list of available annual reports can be 

found at http://www.fda.gov/cdrh/organiz-info.html and at www.FDA.gov/CDRH. 

CDRH WEB SITES

Internet addresses are listed in many sections of this report. CDRH encourages readers to 

visit these web sites and take advantage of the vast amount of information available in 

them. 

www.FDA.Gov/CDRH 

CDRH FY 2005 Annual Report 46