Center for Devices and Radiological Health 

CDRH FY 2006 Highlights 

October 1, 2005–September 30, 2006 

U.S. Food and Drug Administration U.S. Department of Health and Human Services 
 CDRH FY 2006 Annual Report Page 2 

Mission/Vision 

Mission

CDRH protects the health of the public by assuring the safety and effectiveness of medical 

devices and the safety of radiological products marketed in the United States. To further 

safeguard public health, CDRH monitors medical devices and radiological products while in 

use for continued safety and disseminates accurate, science-based information about the 

regulated products. 

Vision 

To protect the health of the public by assuring the safety of medical devices and radiological 

products throughout the Total Product Life Cycle—from product conception and 

development, through production and use, to obsolescence and product replacement. 
 CDRH FY 2006 Annual Report Page 3 

Message from the Center Director 

Fiscal year 2006 coincided with the 100th Anniversary of the FDA, the oldest consumer 

protection agency in the nation. As one of five FDA centers, the Center for Devices and 

Radiological Health (CDRH) plays an integral role in efforts to safeguard the public health. It is 

therefore fitting to align CDRH fiscal year 2006 accomplishments with four overarching 

Agency goals: 

 To empower patients and consumers and enhance public health through better 

information about regulated products; 

 To increase access to innovative products and technologies to improve health; 

 To improve product quality, safety, and availability through better manufacturing and 

product oversight; and 

 To transform FDA business operations, systems, and infrastructure to support FDA’s 

mission in the 21st century. 

 

As an introduction to the Center’s Fiscal Year (FY) 2006 Annual Report, I would like to 

highlight select accomplishments under each of the four goals. I highlight these 

accomplishments on behalf of and in recognition of the many individuals—staff and 

stakeholders—who contributed to the successful work of CDRH during the fiscal year. 

To empower patients and consumers and enhance public health through better 

information about regulated products 

The CDRH website increasingly serves as the source of information about regulated products 

for consumers, clinicians, and industry. An important addition to the website this fiscal year 

was the RightNow Inquiry Management System. The system provides ready answers to 

consumers frequently asked questions and integrates questions posed online. 

CDRH outreach staff also consolidated and organized medical device safety information on a 

single page of the CDRH website to afford healthcare professionals easy access to the 

information. 

The Annual Report contains detail on numerous activities (courses, workshops, conferences, 

etc.) that CDRH co-sponsored with industry. These activities testify to the Center’s ongoing 

commitment to provide information and regulatory assistance to device manufacturers. 

To increase access to innovative products and technologies to improve health 

 

I am pleased to report that CDRH continues to make steady progress in meeting MDUFMA 

performance goals. The Center has met or is on track to meet most goals for FYs 2003–2006. 

During this FY, CDRH issued 6 MDUFMA guidance documents; held 2 MDUFMA 

stakeholders meetings; issued 14 Federal Register notices and 3 reports to Congress; and 

granted 698 Small Business Determinations—an 8 percent increase over FY 2005. 

CDRH applied research is a springboard for development of new device technologies. Among 

the Center’s research-related strengths is the availability of scientists with cutting-edge 
 CDRH FY 2006 Annual Report Page 4 

expertise in a range of fields. This is evident, for example, in multi-disciplinary efforts in FY 

2006 to assure readiness to address future nanotechnology products and issues. 

Each year one of the most rewarding aspects of developing the annual report is listing 

approved/cleared devices that have a direct impact on patient care. CDRH was pleased to 

grant a Clinical Laboratory Improvement Amendment (CLIA) waiver for a simple and accurate 

rapid blood lead test system. The waiver broadened access to the test to more than 115,000 

point-of-care locations nationwide. Devices approved during FY 2006 included a continuous 

glucose monitoring system that detects blood glucose trends and tracks patterns for diabetic 

patients and a device that provides an alternative to open heart surgery for pediatric and 

young adult patients. 

To improve product quality, safety, and availability through better manufacturing and 

product oversight 

The Center continues to enhance postmarket oversight to ensure the safety and effectiveness 

of products. During FY 2006, CDRH received over 200,000 adverse event reports concerning 

medical devices, classified 651 recall actions involving 1,550 products, and took at least 55 

enforcement actions. CDRH exceeded FY 2006 inspection goals by at least 20 percent for 

domestic, foreign, and bioresearch monitoring (BIMO) inspections. The Center also conducted 

annual inspections at over 8,000 mammography facilities, ensuring that 98 percent met 

inspection standards with less that 2 percent of the facilities having Level I (serious) problems. 

To transform FDA business operations, systems, and infrastructure to support FDA’s 

mission in the 21st century 

As part of an ongoing effort to improve the postmarket tools we employ to monitor nearly 

100,000 medical products, the Center produced a comprehensive report on the Postmarket 

Device Safety Program. The report highlighted implementation challenges and recommended 

action steps to strengthen the program. A senior level Postmarket Transformation Leadership 

Team met throughout FY 2006 to evaluate the recommendations and propose a plan for a 

transformed postmarket program. 

During the fiscal year, CDRH enhanced Center IT systems to facilitate submissions, expedite 

reviews, and simplify tracking of devices throughout the product life cycle. 

The availability of excellent staff is paramount to the Center’s success and attention to training 

through the new employee orientation program, and the competency development program 

was another hallmark of FY 2006. 

Spurred by our successes and cognizant of the challenges inherent in an ever expanding 

market for medical devices and radiological products, CDRH staff is committed to continuing 

the work outlined in this Annual Report. We hope that you will read the report with interest and 

that it will reinforce your trust in our ability to ensure the safety and effectiveness of the 

medical products you depend upon. 

Daniel G. Schultz, M.D. 

Director
Contents 

FDA Goal 1—Empowering Patients and Consumers and Enhancing Public Health 

through Better Information about Regulated Products .......................................8

Information for Consumers .................................................................................. 8

CDRH Consumer Information on the Web......................................................................... 8

Information for Healthcare Professionals.................................................................. 9

Epidemiology and Surveillance ...................................................................................... 9

Medical Device Safety ................................................................................................ 9

Safety Tips for Laboratorians ...................................................................................... 10

FDA Patient Safety News .......................................................................................... 10

Public Health Notifications.......................................................................................... 10

Information for Industry .....................................................................................10

Frequently Asked Questions for Manufacturers of Electronic Products that Emit Radiation.............. 11

Unique Device Identifiers ........................................................................................... 11

Courses, Workshops, and Presentations ........................................................................ 11

FDA Goal 2—Increasing Access to Innovative Products and Technologies to Improve 

Health ...................................................................................................13

Approved/Cleared Devices .................................................................................13

LeadCare® II Blood Lead Test System ........................................................................... 14

STAN® S31 Fetal Heart Monitor................................................................................... 14

X STOP® Interspinous Process Decompression System ..................................................... 14

Avian Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set ................. 14

UniCel® DxC 600i Synchron® Access® Chemistry-Immunoassay System .................................. 15

LUMATM Cervical Imaging System ................................................................................ 15

DexComTM STSTM Continuous Glucose Monitoring System .................................................. 15

MonoPrep Pap Test................................................................................................. 16

PhiCalTM Fecal Calprotectin Immunoassay ...................................................................... 16

Birmingham Hip Resurfacing (BHR) System .................................................................... 16

Xpert GeneXpertTM Dx Test For Group B Streptococcus ...................................................... 16

Adept® Adhesion Reduction Solution (4% Icodextrin).......................................................... 17

APTIMA Combo 2® Assay on the TIGRIS® System ............................................................ 17

Gore HELEXTM Septal Occluder................................................................................... 17

Regulations, Standards, and Guidance...................................................................17

CDRH Standards Program ......................................................................................... 17

Guidance Documents ............................................................................................... 18

Quality Review Program for Premarket Submissions...................................................19

Advisory Committees........................................................................................19

Premarket Critical Path .....................................................................................19

MDUFMA......................................................................................................19
 CDRH FY 2006 Annual Report Page 6 

Progress in Meeting MDUFMA Performance Goals ............................................................ 20

MDUFMA Third Party Inspection Program....................................................................... 20

MDUFMA Guidance Document Development................................................................... 20

MDUFMA Stakeholders Meetings................................................................................. 20

MDUFMA Public Notices and Reports............................................................................ 21

MDUFMA Small Business Determinations (SBDs) ............................................................. 21

Applied Research ............................................................................................21

Nanotechnology in Medical Devices .............................................................................. 21

Device Safety in Magnetic Resonance Imaging (MRI) Environments........................................ 22

Relationship Between Bone Cement Dose and Mechanical Strength after Vertebroplasty............... 22

Exposure to Electromagnetic Fields and the Effect on Implanted Devices.................................. 22

Test Methods for Intraocular Lenses (IOL)....................................................................... 23

Combined Approach to Evaluate Circulatory Assist Devices.................................................. 23

Effects of Optical Energy ........................................................................................... 23

Device-Tissue Interfaces ........................................................................................... 23

Better Animal Models and Biomarkers to Improve Public Health ............................................. 24

Infection Control: Reuse of Single-use Devices and Cleaning Validation ................................... 24

Drug Coated Stents: Drug Eluting Stents Associated Thrombosis ........................................... 24

Computational Fluid Dynamics of Left Ventricular Assist Device ............................................. 25

Computer-Assisted Diagnostic Systems ......................................................................... 25

Tools for the Simulation of Imaging Physics..................................................................... 25

Performance Testing of Pulse Oximeters ........................................................................ 25

Test Methods for High Intensity Focused Ultrasound .......................................................... 26

Effect of RFID on Drug Potency ................................................................................... 26

Reorientation of the CDRH Radiation Metrology Program .................................................... 26

Medical Device Fellowship Program ......................................................................26

FDA Goal 3—Improving Product Quality, Safety, and Availability through Better 

Manufacturing and Product Oversight..........................................................28

Postmarket Surveillance ....................................................................................28

Post-approval Studies Program ................................................................................... 28

Postmarket Surveillance............................................................................................ 28

Section 522 Studies ................................................................................................. 29

MedSun ............................................................................................................... 29

Medical Device Reports ............................................................................................ 29

Compliance and Enforcement..............................................................................30

Enforcement Actions ................................................................................................ 30

Warning Letters ...................................................................................................... 30

Recalls ................................................................................................................ 30

Expert Witnesses .................................................................................................... 31

Inspection .....................................................................................................31

Inspection Goals ..................................................................................................... 31

Bioresearch Monitoring (BIMO) Audits and Enforcement Activities .......................................... 31
 CDRH FY 2006 Annual Report Page 7 

Risk-Based Inspection Work-Plan................................................................................. 33

Infusion Pump Project............................................................................................... 33

Evaluation of Inspection Violations................................................................................ 33

Mammography Quality Standards Act (MQSA)..........................................................33

MQSA Program Inspections ....................................................................................... 33

MQSA Enforcement Actions ....................................................................................... 33

Collaborations ................................................................................................34

Software Forensics Laboratory .................................................................................... 34

Defibrillator Working Group ........................................................................................ 34

Agency for Healthcare Research and Quality ................................................................... 34

Interagency Registry for Mechanically-assisted Circulatory Supports (Intermacs)......................... 35

e-Bay and the Federal Trade Commission (FTC)............................................................... 35

Global Harmonization .......................................................................................35

Health Canada ....................................................................................................... 35

International Organization for Standardization (ISO)........................................................... 35

Global Medical Device Nomenclature ............................................................................ 36

Global Harmonization Task Force (GHTF)....................................................................... 36

FDA Goal 4—Transforming FDA Business Operations, Systems, and Infrastructure to 

Support FDA's Mission in the 21st Century....................................................37

CDRH Management.........................................................................................37

Medical Device Postmarket Transformation Initiative .......................................................... 37

CDRH Operational Plan ............................................................................................ 37

Communications Improvement Initiative ......................................................................... 38

IT Enhancements ............................................................................................38

Electronic Submissions ............................................................................................. 38

Electronic Review.................................................................................................... 39

Electronic Tracking .................................................................................................. 39

Training CDRH Staff.........................................................................................40

Staff College.......................................................................................................... 40

New Employee Orientation Program.............................................................................. 41

Competency Development Program.............................................................................. 41

CDRH Leadership Programs....................................................................................... 42

Educational Broadcasts............................................................................................. 42

Homeland Security ..........................................................................................42

Radiological Counterterrorism and Radiation Safety ........................................................... 42

Emergency Preparedness.......................................................................................... 43
 CDRH FY 2006 Annual Report Page 8 

FDA Goal 1—Empowering Patients and Consumers and 

Enhancing Public Health through Better Information 

about Regulated Products 

Through its Risk Communications Outreach Program, CDRH communicates risk/benefit 

information on medical devices and radiological products to Center stakeholders—

consumers, healthcare professionals, and industry. During FY 2006, CDRH continued to 

relay information to stakeholders in a variety of ways. 

Information for Consumers 

Better information enables consumers to make smarter choices about the medical devices 

they rely upon daily. During FY 2006, CDRH staff responded to over 8,400 consumer 

inquiries concerning regulated products received via phone and fax, electronically, and 

through the mail. 

CDRH Consumer Information on the Web 

Important information about medical devices is available to the public via the CDRH home 

page on the FDA website. The page links users to news and events, health topics, device 

program areas, and consumer information. www.fda.gov/cdrh

 RightNow Inquiry Management System 

To make outreach to consumers more efficient, CDRH launched the web-based RightNow

inquiry management system. The system offers visitors a user-friendly way to find answers 

to frequently asked questions and the opportunity to submit new questions. Answers to 

questions posed online are integrated on the website. The link “Questions?” now appears in 

the CDRH banner at the top right of the Center’s home page; the link will eventually appear 

on every CDRH web page. 

 Medical Device Recall Website 

Medical devices that are defective and/or pose a risk to health are recalled to address the 

problem. CDRH alerts the public to recalled products via public health notices, press 

releases, and its recall website. In its recall website FDA posts consumer information about 

the most serious medical device recalls. These products are on the list because there is a 

reasonable chance that they could cause serious health problems or death. — 

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

 Contact Lenses Web Page 

CDRH launched the contact lenses web page in May 2006. This device-specific page 

provides all current contact lens related information in one place. The page contains basic 

information about contact lenses including the different types, valid prescriptions, a link to 
 CDRH FY 2006 Annual Report Page 9 

approved contact lenses, risks, everyday eye care tips, and what to look out for when buying 

online—http://www.fda.gov/cdrh/contactlenses/

 Maturity Health Matters 

CDRH published the inaugural issue of Maturity Health Matters. The aim of the online 

newsletter is to provide older adults and their caregivers with the latest information on 

medical products that help people live longer, more productive lives. The inaugural issue 

explored the link between diabetes and heart disease, highlighting the key role of medical 

devices in diabetes management. The newsletter will be published three times a year and 

feature information on FDA, regulated medical products, and health news.—

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

 FDA & You 

For the third year, CDRH published FDA & You, an informative e-newsletter for secondary 

school students, parents, and educators. Published three times during the school year, FDA 

& You keeps students informed of latest news on medical products. Educators can use 

supplementary lesson plans for news-related classroom activities. Soft Contact Lens: Risk of 

Serious Eye Infection is an example of a newsletter article posted online during the fiscal 

year.—http://www.fda.gov/cdrh/fdaandyou/index.html

 FDA Centennial at CDRH 

To commemorate the 100th anniversary of FDA and the major milestones celebrated by 

CDRH in 2006, the Center launched the FDA Centennial at CDRH website.—

http://www.fda.gov/cdrh/centennial. The site includes an overview of CDRH, a chronological 

recap of Center milestones, and insights on challenges faced by past and present Center 

leadership. In conjunction with the website, CDRH developed a Centennial brochure and a 

commemorative calendar.

Information for Healthcare Professionals 

Public health is improved when the clinical community is well-informed about the safe use 

of medical devices. During FY 2006, CDRH continued educational outreach to healthcare 

professionals in a variety of ways. 

Epidemiology and Surveillance 

CDRH staff were principal authors as well as editors of Epidemiology and Surveillance. The 

textbook describes how epidemiology and surveillance are conducted on marketed medical 

devices and why this is necessary in order to ensure that devices remain safe and effective 

during the course of their use. Because there are currently no published books, university 

courses, or professional societies that focus on the topic, Epidemiology and Surveillance

will fill an important void in the American public’s knowledge of this subject. 

Medical Device Safety 

The Center’s resource for health care professionals is the Medical Device Safety page on 

the CDRH website. In FY 2006, staff consolidated and organized all medical device safety 

information (safety tips and articles, public health notifications, the adverse events 

database, etc.) and related links to appear on the page. To enhance effective distribution of 
 CDRH FY 2006 Annual Report Page 10 

safety information, CDRH updates the page regularly to feature high priority risk messages. 

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

Safety Tips for Laboratorians 

During the postmarket lifecycle of in vitro diagnostic devices (IVDs), CDRH collects 

information on a variety of experiences relating to the proper use of the devices. This 

experience-based information also includes precautions that laboratorians, prescribing 

physicians, or the lay user must exercise in order to perform tests and use results 

appropriately. To communicate this valuable postmarket experience, CDRH posts Safety 

Tips For Laboratorians on its website at http://www.fda.gov/cdrh/oivd/labsafetytips.html. 

The short articles on conducting laboratory tests properly include guidance on test 

limitations and interfering factors that cause false or inaccurate test results. 

FDA Patient Safety News 

CDRH leads the Agency production of FDA Patient Safety News (FDA PSN), an award 

winning televised series carried on satellite broadcast networks aimed at hospitals and 

other medical facilities across the country. Now in its fifth year of production, FDA PSN is a 

major Agency vehicle for communicating FDA safety messages on drugs, medical devices, 

and biologics to physicians, nurses, pharmacists, risk managers, and educators across the 

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

Public Health Notifications 

CDRH communicates critical health information the health care community through public 

health notifications. The notifications alert consumers and healthcare providers to actual or 

potential risks associated with use of a medical device and provide recommendations to 

avoid or reduce risks. In addition to being posted on the CDRH website, public health 

notifications are disseminated through MedWatch (the FDA safety information and adverse 

event reporting program), professional associations, two listservs, and press releases.

CDRH encourages readers to subscribe to email updates to receive email announcements 

when a new or revised notification is issued. —http://www.fda.gov/cdrh/safety.html

Information for Industry 

Outreach to educate industry stakeholders is a Center priority. During FY 2006, CDRH staff 

responded to over 63,000 industry requests concerning regulated products received via 

phone and fax, electronically, and through the mail; collaborated with trade organizations to 

co-sponsor educational activities on a range of topics; and solicited industry expertise 

concerning new initiatives. Center outreach to industry is international; during FY 2006, 

staff met with 22 foreign officials representing 5 foreign governments to improve the safety 

of medical devices around the world. Below are some examples of CDRH outreach to 

industry during FY 2006. 
 CDRH FY 2006 Annual Report Page 11 

Frequently Asked Questions for Manufacturers of Electronic Products that Emit 

Radiation 

CDRH launched the Frequently Asked Questions for Manufacturers of Electronic Products 

that Emit Radiation web page in July 2006. The web page provides basic explanations to 

common questions related to manufacturer reporting and recordkeeping responsibilities, 

report acknowledgement letters and accession numbers, product certification to 

performance standards, and importation of electronic products. 

http://www.fda.gov/cdrh/radhealth/rademitfaq.html

Unique Device Identifiers 

FDA published a notice requesting comments to help the Center understand how the use of 

unique device identifiers (UDI) similar to identifiers mandated for drugs might enhance 

patient safety. CDRH subsequently held a public meeting which focused on factors 

influencing the development of a UDI system (e.g., costs, benefits, design and 

implementation challenges, data repository, automatic identification technologies). The 

Center is currently analyzing the comments to determine FDA’s role and approach to a UDI 

system. 

Courses, Workshops, and Presentations 

 PMA and 510(k) Device Submission Workshops 

In March 2006, several CDRH staff members participated in the annual PMA and 510(k) 

Device Submission Workshops sponsored by the Advanced Medical Technology 

Association (Advamed) Medical Technology Learning Institute (MTLI). The objective of 

these annual workshops is to educate regulatory professionals on how to prepare a 

successful PMA or 510(k) application, and how to comply with FDA regulatory requirements. 

During the workshops, CDRH staff also share practical review experience with the 

participants. 

 IVD Roundtable 510(k) Workshop 

In April 2006, CDRH and the Association of Medical Diagnostics Manufacturers (AMDM) cosponsored the In Vitro Diagnostic Devices (IVD) Roundtable 510(k) Workshop. The 

objective of the workshop was to foster communication among the professional, 

manufacturing, and regulatory communities. During the interactive workshop, participants 

had the opportunity to learn from CDRH experts who review 510(k) submissions. 

Experienced industry regulatory affairs personnel also provided guidance and helpful tips on 

510(k) submissions. 

 PMA and 501(k) Web Casts 

In May 2006, CDRH regulatory experts were invited to participate in the Regulatory 

Association Professional Society (RAPS) web cast. The objective of this web cast was to 

educate the regulated industry on the fundamentals of 510(k) and PMA applications. CDRH 

staff also discussed tips on how to prepare for an FDA panel meeting. The training was 

broadcast over the Internet and attended by many regulatory professionals throughout the 

world. 
 CDRH FY 2006 Annual Report Page 12 

 Medical Design and Manufacturing (MD&M) East 2006 Conference 

In June 2006, CDRH staff participated in the annual MD&M East 2006 Conference. CDRH 

staff hosted a booth at the conference and sponsored a one-day seminar dealing with preand postmarket activities. The MD&M East 2006 Conference attracted more than 25,000 

design engineers, production managers, quality control specialists, manufacturing 

executives, and other product development professionals from across the industrial 

landscape. 

 Good Manufacturing Practices/Quality System Requirements and Industry Practices 

This Association for the Advancement of Medical Instrumentation (AAMI) course offered in 

September 2006 was co-presented by CDRH and industry instructors to educate members 

of regulated industry on the fundamentals of the Quality System Regulation. CDRH staff 

presented multiple training modules and provided guidance on FDA expectations related to 

implementing medical device Current Good Manufacturing Practice Requirements/Quality 

System Regulation. 

 Risk Communication on Medical Devices: Sharing Perspectives 

In September 2006, FDA and the Advanced Medical Technology Association (AdvaMed) 

presented a workshop entitled Risk Communication on Medical Devices: Sharing 

Perspectives. Senior FDA and industry representatives explained to participants how the 

government and the medical device industry communicate expected and unexpected risks 

to practitioners, patients, and the public. Attendees also learned from physicians, risk 

managers, and the media how this information is received and transmitted to hospital staff, 

patients, and the public. 

 Connecting the Dots on FDA's Postmarket Safety Activities 

This was the first in a series of planned public workshops on postmarket safety of medical 

devices. The goal of the workshops, held in collaboration with the Advanced Medical 

Technology Association (AdvaMed) Medical Technology Learning Institute (MTLI), is to 

improve regulatory processes and oversight of marketed medical devices by gaining a better 

mutual understanding of current barriers to postmarket device monitoring and follow-up. 

Workshop topics included FDA analysis of postmarket trends; industry's perspective on 

postmarket issues and regulations; new perspectives on product recalls, removals, and 

corrections; future trends in postmarket regulation; and industry/FDA collaboration. 
 CDRH FY 2006 Annual Report Page 13 

FDA Goal 2—Increasing Access to Innovative Products 

and Technologies to Improve Health 

A critical aspect of protecting and promoting public health is facilitating access to innovative 

medical devices. To achieve this objective, CDRH is developing better ways to predict 

earlier in the review process which new products are likely to be safe and effective. CDRH 

is also promoting scientific innovation in product development and focusing device research 

using cutting-edge science. 

Approved/Cleared Devices 

FDA does not test new medical devices to determine whether they are safe and effective 

before they are sold in the United States. Instead, FDA gives guidance to manufacturers on 

what tests they should conduct. CDRH evaluates the scientific test data manufacturers 

submit for review prior to making a decision whether the devices are allowed to be 

marketed. 

Manufacturers wishing to sell a new type of medical device—or market an approved device 

for new uses that represent a high risk to public health—must submit a premarket approval 

(PMA) application to CDRH. A PMA must include valid scientific evidence showing that the 

product does what it claims to do (is effective) and that the benefits of using the product 

outweigh the risks (is safe). Examples of PMA devices include: mechanical heart valves, 

implantable pacemakers, intra-ocular lenses, and cochlear implants. 

Most new medical devices are similar to products already on the market and do not 

represent a high risk to public health. Manufacturers wishing to sell these products must 

submit a premarket notification [also called 510(k)]. This process is for lower-risk devices 

that require less rigorous testing and evaluation. A 510(k) must include information 

demonstrating that the new device is very similar (substantially equivalent) to another 

device already on the market. Some applications for devices with well-established records 

of safety and use receive no review. Examples of 510(k) devices include: non-invasive 

blood pressure monitors, ventilators, and daily wear soft contact lenses. 

Medical devices successfully evaluated through the PMA process are approved; devices 

successfully evaluated through the 510(k) process are cleared. 

During FY 2006, CDRH approved and cleared a significant number of medical devices 

which exemplify advanced device technologies that have a valuable impact on patient care. 

A comprehensive list of approved medical devices is available at 

http://www.fda.gov/cdrh/consumer/mda/index.html.
 CDRH FY 2006 Annual Report Page 14 

LeadCare® II Blood Lead Test System 

http://www.fda.gov/cdrh/pdf5/k052549.pdf

The LeadCare II Blood Lead Test System is used to screen 

children and adults for harmful levels of lead using a finger stick or 

venous whole blood sample. It is performed while the patient is 

present in as little as three minutes. The rapid result means a 

second sample for confirmatory testing can be obtained quickly, 

reducing the need for a follow-up visit. Because the test is simple, 

accurate, and reasonably free of harm, CDRH broadened access 

to the test system by granting a Clinical Laboratory Improvement 

Amendment (CLIA) waiver. The waiver permits widespread 

distribution of the test system to nontraditional laboratory sites that 

have CLIA certification. 

STAN® S31 Fetal Heart Monitor 

http://www.fda.gov/cdrh/mda/docs/p020001.html

The STAN® S31 Fetal Heart Monitor is a new type of fetal monitor that uses the fetal 

electrocardiogram (ECG) obtained through a fetal scalp electrode during labor to help the 

doctor or midwife decide whether to allow the mother to continue to labor or to intervene 

and deliver the baby. The new monitor is used when there is concern that the fetus might 

be at increased risk for metabolic acidosis.

X STOP® Interspinous Process Decompression System 

http://www.fda.gov/cdrh/mda/docs/p040001.html

The X STOP® Interspinous Process Decompression System (X STOP) is used to relieve 

symptoms of lumbar spinal stenosis, a narrowing of the passages for the spinal cord and 

nerves. The titanium implant that fits between the spinous process of the lower (lumbar) 

spine may relieve some or all of the symptoms of lumbar spinal stenosis and may improve 

a patient’s ability to function. 

Avian Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set 

http://www.fda.gov/cdrh/pdf6/k060159.pdf

The Avian Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set 

provides preliminary results on suspected H5 influenza samples within four hours once 

testing begins. This is in contrast to previous testing technology which required at least two 

to three days for results. If the presence of the H5 strain is identified, then further testing is 

conducted to identify the specific H5 subtype (e.g., H5N1). 
 CDRH FY 2006 Annual Report Page 15 

UniCel® DxC 600i Synchron® Access® Chemistry-Immunoassay System 

http://www.fda.gov/cdrh/pdf6/k060256.pdf

The UniCel® DxC 600i Synchron was cleared 

as the only system of its kind with closed-tube 

sampling (CTS) and closed-tube aliquotting 

(CTA) capabilities. By eliminating the decapping and re-capping steps in the laboratory 

process, these features help increase lab 

efficiency and enhance operator safety. The 

system offers a throughput up to 990 chemistry 

tests per hour and up to 100 immunoassay 

tests per hour. 

LUMATM Cervical Imaging System 

http://www.fda.gov/cdrh/mda/docs/p040028.html

The LUMATM Cervical Imaging System is an optical detection system that helps the doctor 

identify areas on the cervix that are likely to contain precancerous cells. The doctor uses 

this device immediately after colposcopy (a high magnification evaluation of the cervix for 

women who have recently had an abnormal Pap smear) to decide where to take additional 

tissue samples (biopsies). The LUMATM Cervical Imaging System will help improve the 

chances that the doctor does not miss an area that may contain precancerous cells. 

DexComTM STSTM Continuous Glucose Monitoring System 

http://www.fda.gov/cdrh/pdf5/p050012a.pdf

 DexComTM STS® Continuous Glucose Monitoring System is 

a short-term sensor that wirelessly transmits glucose 

readings to a hand-held receiver to provide real-time 

continuous measurements. The system, used by adult 

diabetic patients at home and in health care facilities, detects 

trends and tracks patterns. The device aids in detecting 

episodes of hyperglycemia and hypoglycemia, facilitating 

both acute and long-term therapy adjustments, which may 

minimize high and low blood sugar levels. 
 CDRH FY 2006 Annual Report Page 16 

MonoPrep Pap Test 

http://www.fda.gov/cdrh/mda/docs/p040052.html

The MonoPrep Pap Test (MPPT) system is a 

device used to collect and prepare cell samples 

from a female patient’s cervix for Pap stain-based 

screening for cervical cancer, its precursor lesions, 

and other cytologic categories and conditions. 

Clinical trial results demonstrate that the MPPT 

system is safe and effective for preparing 

gynecological slides to screen for cervical 

abnormalities. 

PhiCalTM Fecal Calprotectin Immunoassay 

http://www.fda.gov/cdrh/pdf5/k050007.pdf

The PhiCalTM Fecal Calprotectin Immunoassay is a quantitative ELISA assay for measuring 

concentrations of human fecal calprotectin, a neutrophilic protein that is a marker of 

mucosal inflammation. The PhiCalTM test can be used as an in vitro diagnostic to aid in the 

diagnosis of inflammatory bowel diseases (IBD), Crohn's disease, and ulcerative colitis, 

and to differentiate IBD from irritable bowel syndrome (IBS) when used in conjunction with 

other diagnostic testing and the total clinical picture. 

Birmingham Hip Resurfacing (BHR) System 

http://www.fda.gov/cdrh/mda/docs/p040033.html

The Birmingham Hip Resurfacing (BHR) System is a metal on metal resurfacing artificial 

hip replacement system, surgically implanted to replace a hip joint. The BHR System 

relieves hip pain and improves hip function by replacing the parts of the hip that have been 

severely damaged by degenerative joint diseases (e.g., osteoarthritis, rheumatoid arthritis, 

traumatic arthritis, dysplasia, avascular necrosis). The BHR System is intended for patients 

who, due to their relatively younger age or increased activity level, may not be suitable for 

traditional total hip replacement due to an increased possibility of requiring future hip joint 

revision. 

Xpert GeneXpertTM Dx Test For Group B Streptococcus 

http://www.fda.gov/cdrh/pdf6/k060540.pdf

This qualitative in vitro diagnostic test is designed to detect Group B Streptococcus (GBS) 

DNA from vaginal and rectal swab specimens. The test rapidly identifies a GBS infection 

before and during labor and delivery. If passed from mother to child during birth, GBS can 

cause sepsis, pneumonia, meningitis, neurological damage, and, in a small percentage of 

newborns, even death. 
 CDRH FY 2006 Annual Report Page 17 

Adept® Adhesion Reduction Solution (4% Icodextrin) 

http://www.fda.gov/cdrh/mda/docs/p050011.html

Adept® Adhesion Reduction Solution (4% Icodextrin) is a pale yellow fluid that contains 

icodextrin. The fluid is used during or after laparoscopic gynecological surgery to separate 

and protect tissues, and decrease the number of new adhesions after surgery. Adhesions 

are a common complication of gynecological surgery, and can cause pelvic pain, bowel 

obstruction, or infertility. 

APTIMA Combo 2® Assay on the TIGRIS® System 

http://www.fda.gov/cdrh/pdf6/k060652.pdf

The APTIMA Combo 2® Assay is cleared to detect Chlamydia infections and gonorrhea 

from a wide variety of sample types. These sample types include liquid-based ThinPrep 

Pap Tests and vaginal swabs, endocervical and urethral swab specimens, and female and 

male urine specimens. 

Gore HELEXTM Septal Occluder 

http://www.fda.gov/cdrh/mda/docs/p050006.html

This new technology is an alternative to open heart surgery for 

pediatric and young adult patients. The device uses cardiac 

catheterization to position an occluder over a hole in the heart, 

allowing tissue to grow over the device, closing the defect, and 

making the device part of the wall of the heart. 

Regulations, Standards, and Guidance 

CDRH is responsible for setting and enforcing FDA regulations and performance standards 

for medical devices and radiation-emitting electronic products. To describe FDA’s 

interpretation of policy on regulatory issues, CDRH staff prepare guidance documents for 

regulated industry and the general public. Regulations, standards, and guidance 

documents are intended to assist manufacturers improve the quality of premarket 

submissions, expedite the FDA review process, and speed consumer access to life-saving 

medical devices. 

During FY 2006, CDRH cleared 20 regulations, reviewed and coordinated the Agency’s 

actions with regard to 16 Citizens’ Petitions, and cleared 46 guidance documents—which is 

a 59 percent increase from FY 2005. 

CDRH Standards Program 

The Standards Management Staff (SMS) develops and manages the standards used for 

regulatory assessments and facilitates the participation of CDRH and other FDA staff in 

developing national and international standards. In addition, the SMS manages CDRH’s 

process for the recognition of voluntary consensus standards for medical devices and 

radiation-emitting electronic products. As part of this responsibility, the staff annually 

publishes lists of recognized standards, consistently increasing the number of available 
 CDRH FY 2006 Annual Report Page 18 

standards. During FY 2006 CDRH withdrew 10 standards considered “no longer 

appropriate”; withdrew 80 additional standards and recognized new editions of each; 

incorporated 66 changes to existing recognized standards; and recognized 43 new 

voluntary consensus standards. The new standards address newly developing 

technologies to improve the quality of future submissions. 

Guidance Documents 

CDRH worked with industry and other stakeholders to develop best practices, policies, and 

guidance documents to make premarket applications more consistent, complete, and less 

subject to multi-cycle reviews. Below are examples of guidance documents issued during 

the FY 2006. 

 Draft Guidance for the Review and Inspection of Premarket Approval Applications 

under the Bioresearch Monitoring Program was developed and issued in 

collaboration with FDA’s Office of Regulatory Affairs. 

 Draft Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials

provides a flexible alternative framework to classical clinical trial design for sponsors 

of innovative new devices. 

 Draft Guidance for Pharmacogenetic Tests and Genetic Tests for Heritable Markers

was issued to facilitate progress in the field of pharmacogenomics and genetics by 

helping to shorten development and review timelines, facilitate rapid transfer of new 

technology from the research bench to the clinical diagnostic laboratory, and 

encourage informed use of pharmacogenomic and genetic diagnostic devices. 

 Draft Guidance Class II Special Controls: Bone Sonometers supports the 

reclassification of bone sonometers into class II (special controls) devices. Class II 

devices are exempt, subject to certain limitations, from the premarket notification 

requirements. Bone sonometers transmit ultrasound energy into the human body to 

measure the acoustic properties of bone that indicate overall bone health and 

fracture risk. 

 Final Guidance for Keratome and Replacement Keratome Blades Premarket 

Notification [510(k)] Submissions will assist industry in preparing premarket 

notification submissions for keratomes and replacement keratome blades. The 

intended use of the device is to shave tissue from sections of the cornea for a 

lamellar (partial thickness) transplant. Keratomes, originally used during cornea 

transplant surgery, are now widely used during the laser refractive surgical 

procedure known as laser-assisted in situ keratomileusis (LASIK). 
 CDRH FY 2006 Annual Report Page 19 

Quality Review Program for Premarket Submissions

The purpose of CDRH’s Quality Review Program for Premarket Submissions is to evaluate 

the quality and consistency of the Center’s scientific review process. During the fiscal year, 

CDRH expanded the program to five review areas: biocompatibility, sterilization and 

packaging, statistical analysis, software, and clinical reviews. The expanded program 

allows CDRH to improve the quality of its reviews in key scientific areas, ensuring that 

reviewers consistently ask the right questions at the right times to minimize review time. 

Advisory Committees 

CDRH held 10 Federal Advisory Committee panel meetings in fiscal year 2006. These 

panels of external experts reviewed and made recommendations to FDA on six premarket 

approval (PMA) applications, three reclassifications, one classification, and three general 

issues. Among the topics addressed at the panel meetings were issues associated with 

significant breakthrough technologies for facial fillers, breast cancer detection, implanted 

telescope for macular degeneration, and cervical disc system for the treatment of 

degenerative disc disease. 

Premarket Critical Path 

Examples follow of CDRH’s Critical Path initiative to address innovative medical therapies 

and support product development that is more predictable, efficient, and less costly: 

 Established a collaboration with the Juvenile Diabetes Research Foundation to 

promote the development of an artificial pancreas; 

 Established collaborative interactions with other government entities and external 

stakeholders to advance the development of new biomarkers for diseases; and 

 Developed guidance to foster the development of new technologies in the area of 

genetics, pharmacogenomics, and drug/device co-development.

MDUFMA 

In 2002, the Federal Food, Drug, and Cosmetic Act was amended to provide FDA 

important new responsibilities, resources, and challenges. The Medical Device User Fee 

and Modernization Act of 2002 is commonly referred to as MDUFMA. 

One particularly significant provision of MDUFMA permits FDA to collect user fees for 

certain premarket reviews received on or after October 1, 2002. The additional funds 

obtained from user fees will enable FDA to improve the medical device review process in 

order to meet MDUFMA performance goals. 
 CDRH FY 2006 Annual Report Page 20 

To meet these progressively challenging performance goals, CDRH consulted with its 

stakeholders, developed guidance documents, and implemented new review processes 

and process improvements. Key MDUFMA-related accomplishments for FY 2006 follow. 

Progress in Meeting MDUFMA Performance Goals 

CDRH met, or is on track to meet, most of the MDUFMA performance goals for fiscal years 

2003 through 2006 receipt cohorts, and maintained review performance in areas not 

covered by official performance goals. http://www.fda.gov/cdrh/mdufma/index.html

MDUFMA Third Party Inspection Program 

CDRH continued implementation of the MDUFMA authority to accredit third parties to 

conduct inspections of eligible manufacturers of Class II and Class III medical devices, 

which will help FDA focus its limited resources on higher-risk inspections and give medical 

device firms operating in global markets an opportunity to more efficiently schedule multiple 

inspections. 

FDA issued guidance to implement the new authority and published criteria for Accredited 

Persons (AP) in the Federal Register. The FDA review board received, reviewed, and rated 

AP applications which resulted in 16 third parties being selected to participate in the 

program. 

Industry use of the Third Party Inspection Program for 510(k) submissions in FY 2006 

increased 18 percent over use of the program in FY 2005. CDRH received 287 510(k) 

submissions reviewed by Accredited Persons and made final decisions on 268, up from 

250 in FY 2005. This review option may be faster than reviews performed exclusively by 

FDA staff and gives manufacturers access to specialized expertise by third parties. 

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

MDUFMA Guidance Document Development 

CDRH issued six MDUFMA guidance documents during FY 2006. The guidance 

documents addressed reprocessed single-use medical devices, combination products, 

small business qualifications, Section 301 compliance (mark of manufacturer on single-use 

devices), premarket approval application (PMA) inspections, and the Bioresearch 

Monitoring (BIMO) Program. http://www.fda.gov/cdrh/guidance.html

MDUFMA Stakeholders Meetings 

In November 2005, CDRH held the third Annual Stakeholders Meeting on the 

Implementation of MDUFMA. In addition to addressing the Agency’s progress in 

implementing the various MDUFMA provisions, meeting participants discussed the current 

qualitative performance goals, participation of eligible manufacturers in the inspection 

program, and the current requirements for reprocessing single use devices. The meeting 

gave stakeholders an opportunity to provide information and share their views on the 

implementation of MDUFMA. http://www.fda.gov/cdrh/meetings/111705.html
 CDRH FY 2006 Annual Report Page 21 

A MDUFMA Public Stakeholders meeting was also held in May 2006 to consult with 

stakeholders and to determine whether the following two goals are appropriate for 

implementation in FY 2007: 

 50 percent of PMA applications will have an FDA decision in 180 days; 

 80 percent of premarket notifications [510(k)s] will have an FDA decision in 90 days. 

http://www.fda.gov/cdrh/meetings/052206.html

MDUFMA Public Notices and Reports 

CDRH issued 14 Federal Register notices and three reports to Congress: FY 2005 

MDUFMA Performance Report, FY 2005 MDUFMA Financial Report, and FY 2005 Office 

of Combination Products Report. 

MDUFMA Small Business Determinations (SBDs) 

CDRH received, evaluated, and responded to 717 Small Business Determinations (SBDs) 

under the meaning of MDUFMA, and granted 698, an increase of 8 percent over FY 2005. 

(Establishments judged to be a small business are eligible to receive a reduced or waived 

user fee for premarket reviews.) CDRH completed all SBDs within 7 days of the allowable 

60-day timeframe. 

http://www.fda.gov/cdrh/mdufma/guidance/2006.pdf

Applied Research 

Research findings improve the predictability, efficiency, and effectiveness of premarket 

reviews and the development of new device technologies. Following are CDRH applied 

research-related accomplishments during FY 2006. 

Nanotechnology in Medical Devices 

CDRH took major steps to assure its readiness to address future nanotechnology products 

and issues. Steps included building a knowledge base and developing experimental 

expertise and collaborative research with other key participants in the field, and discussing 

regulatory processes and standards coordination issues. A major Center strength is the 

availability of scientists from many disciplines—some with significant prior experience with 

nanotechnology. Other activities in progress include coordination of standards activities, 

identification of regulatory issues/gaps, and training of staff. 

The focus of CDRH research projects is primarily to address mechanistic understanding of 

nanoparticles behavior from physical, chemical, and biological aspects. The other major 

focus is on advancing the knowledge regarding the characterization of nanoparticles. The 

knowledge and data developed in these projects would help address potential questions 

related to: 
 CDRH FY 2006 Annual Report Page 22 

 Available methods/technologies for characterization of nanoparticles and their 

limitations; 

 Physico-chemical stability/interaction of nanoparticles; 

 Physical, chemical, and biological interaction of nanoparticles; 

 Toxicity and behavior of nanoparticles in in-vitro and in-vivo environment; and 

 Test methods to assess biocompatibility of nanoparticles’ exposure to blood 

elements. 

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 

and its confusing MRI compatible terminology, which may have resulted in patient injuries. 

CDRH measured and modeled implants in MRI radio frequency fields to develop data on 

induced heating. These data will aid in the formulation of guidance and standards for MRI 

compatibility of implants. 

Relationship Between Bone Cement Dose and Mechanical Strength after 

Vertebroplasty 

CDRH conducted research to determine whether bone mineral density (BMD) can be used 

to predict mechanical strength and stiffness of the vertebral body after cement injection. 

Vertebroplasty has been reported to have high success rates in providing pain relief, but 

the procedure is not without serious risks. Adverse events associated with cement leakage 

have been reported, including persistent pain, paralysis, loss of sensation, and death. 

Laboratory results suggest that there may be significant differences between osteoporotic 

and non-osteoporotic patients in terms of the relative improvement in strength and stiffness 

that larger cement volumes can offer. In general, laboratory study suggests that clinicians 

may be able to select an appropriate cement volume and to make predictions about the 

expected improvement in mechanical stability after vertebroplasty for a specific patient 

based on his or her bone mineral density. 

Exposure to Electromagnetic Fields and the Effect 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 cellular phone exposure and models of pregnant women representing nine 

fetal gestational ages to evaluate heating during MRI. This effort resulted in the 

standardization of specific absorption rate (SAR) across multiple systems. Results of this 

work include: 

 Nine journal articles and 14 proceedings and other presentations during the past 

year; 

 Support from the Federal Aviation Administration (FAA)/Transportation Security 

Administration (TSA) for the security system studies; and 

 Establishment of a Cooperative Research and Development Agreement (CRADA) to 

further the virtual family modeling. 
 CDRH FY 2006 Annual Report Page 23 

Modeling of the heating effects of MRI upon implanted pacemakers, implantable 

cardioverter-defibrillators (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 as industry uses the information 

to improve device safety. 

Test Methods for Intraocular Lenses (IOL) 

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

testing intraocular lenses (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, 4 journal articles, and more than 10 proceedings publications and 

presentations during the past year. 

CDRH also developed accelerated testing procedures to identify IOL materials that are 

prone to the formation of “glistenings” (fluid filled ellipsoidal voids within the lens). Both of 

these testing procedures ensure the effectiveness and safety of a device for the treatment 

of cataracts that is critical to an aging population. 

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 

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 4 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 journal articles and several presentations. 
 CDRH FY 2006 Annual Report Page 24 

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, a 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 developed cleaning and disinfection-sterilization methods to ensure that no 

microbial contamination remains on a reusable device. Improper cleaning can cause 

misdiagnosis due to tissue contamination and toxicity from residual detergents and 

sterilization agents. 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 reusable 

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 review 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 vascular endothelial growth factor (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. Experimental and computational studies of 

model coatings have led to an understanding of the role of processing conditions on the 

rate of drug release. For example, increases in processing temperature leads to a decrease 

in the size of included drug particles and an increase in the rate of drug release. These 
 CDRH FY 2006 Annual Report Page 25 

observations have been used in evaluating proposed changes to manufacturing procedures 

in currently approved drug eluting stents. 

Computational Fluid Dynamics of Left Ventricular Assist Device

CDRH laboratory scientists worked with an industry sponsor to assess the effect of a 

proposed design change to a left ventricular assist device (LVAD). The sponsor proposed 

making 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 CDRH 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 developed new models and methods for assessing computer-assisted diagnostic 

(CAD) systems in the review of digital mammography systems, breast cancer screening, 

lung cancer screening, and computed tomography (CT) colonoscopy. The new assessment 

tools can be used with the most common clinical study design paradigms. The new 

assessment tools have been developed to improve the evaluation of reader variability and 

algorithm complexity for imaging and CAD devices by extending these assessment tools to 

the most common clinical study design paradigms. CDRH research has also lead to a 

better understanding of the impact of CAD used concurrently instead of as a second 

reader, and to the development of assessment tools for measuring CAD stand-alone 

performance. Having these tools and methods available has greatly assisted developers of 

these innovative imaging and CAD devices. 

Tools for the Simulation of Imaging Physics 

CDRH scientists have developed and made available to the scientific community, an 

advanced simulation package for studying radiation imaging systems. The code, developed 

in collaboration with scientists at the Universitat Politecnica de Catalunia in Spain, allows 

for the simulation of medical imaging systems involving x-rays, gamma-rays, electrons, and 

optical radiation, such as digital mammography, breast tomosynthesis, breast, and other 

flat-panel based CT. The tool will enhance the Center's understanding of the physics 

behind novel imaging technologies that are currently being considered by industry and 

possibly submitted to FDA for review in the near future. 

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 
 CDRH FY 2006 Annual Report Page 26 

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 

high intensity focused ultrasound (HIFU) 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. 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 predict the performance of the device under conditions that would 

have been difficult to investigate experimentally, thus shortening the review time. 

Effect of RFID on Drug Potency 

CDRH initiated, at the request of FDA, important new research to determine whether 

exposure to electromagnetic fields from radiofrequency identification (RFID) systems has 

any effect on the potency of pharmaceuticals. Of primary interest are exposures that are 

several times more severe than the anticipated worst-case field strengths and durations. 

Reorientation of the CDRH Radiation Metrology Program 

As part of the CDRH reorganization of the radiation health program, the CDRH X-ray 

Calibration Laboratory underwent significant changes. The laboratory continues to be 

accredited by the National Voluntary Accreditation Program (NVLAP). During the fiscal 

year, the laboratory provided 840 radiation calibrations of general diagnostic instruments, 

202 radiation calibrations of mammographic instruments, 484 electrical calibrations of 

radiation monitors, 147 calibrations of non-invasive kVp meters, and 36 calibrations of light 

meters. In addition, the laboratory provided instrumentation and logistics support to FDA 

and Agreement-State inspectors for compliance testing of general radiography installations, 

mammography machines, and voluntary surveys under the Nationwide Evaluation of X-ray 

Trends (NEXT) program. 

Medical Device Fellowship Program 

The Medical Device Fellowship Program (MDFP) provides select individuals the opportunity 

to get unique, hands-on experience helping to evaluate the safety and effectiveness of 

cutting-edge medical devices. MDFP fellows include student interns starting their careers in 

science and engineering and senior scientists and physicians with vast experience in 

academia and clinical practice. By increasing the range and depth of collaboration between 

CDRH and the outside scientific community, the MDFP helps ensure that CDRH decisions 

are based on the best scientific information and knowledge available. In 2007, MDFP 

fellows contributed expertise in ophthalmology, interventional cardiology, cardiac surgery, 

neurology, gastroenterology, biostatistics, and biomedical engineering. 
 CDRH FY 2006 Annual Report Page 27 

The Center’s technology transfer program, managed through the MDFP, makes possible 

collaboration with people and programs outside FDA, augmenting CDRH expertise and 

resources. Government and academic partnerships (e.g., cooperative research 

agreements, grants, memorandums of understanding for academic partnerships, 

interagency agreements, material transfer agreements) result in scientific information being 

used to develop standards, guidance, and regulatory decisions.
 CDRH FY 2006 Annual Report Page 28 

FDA Goal 3—Improving Product Quality, Safety, and 

Availability through Better Manufacturing and Product 

Oversight 

To ensure the safety and effectiveness of medical devices and radiation-emitting products, 

CDRH sets and enforces good manufacturing practice requirements; monitors compliance 

and surveillance programs for products on the market; and collects, analyzes, and acts on 

reports of adverse effects of products. The Center’s goal is to improve the prioritization, 

coordination, consistency, quality, and timeliness of inspections, reporting, and 

enforcement actions to ensure the continued safety and effectiveness of products on the 

market. 

Postmarket Surveillance 

These accomplishments exemplify CDRH’s efforts during FY 2006 to advance patient 

safety by improving problem detection capabilities in marketed device products. 

Post-approval Studies Program 

CDRH continued to make great strides in its Post-approval Studies (PAS) Program. The 

Center issued a draft guidance—Procedures for Handling Post-approval Studies Imposed 

by PMA Order—to enhance the efficiency and effectiveness of studies conducted by 

manufacturers as a condition of device approval. The guidance presents suggested format 

and content for reports on these studies, mentions presentations to Advisory Panels (to 

enhance study transparency), and notes possible enforcement actions when there is failure 

to comply. In addition, CDRH conducted regular meetings with the Implementation 

Workgroup (providing CDRH management oversight) to assure the smooth transition of the 

program and develop best practices. The epidemiology staff thoroughly reviewed all 

submissions for new PMAs and led the identification of post-approval questions, the design 

of new PAS, and review of ongoing PAS. 

Postmarket Surveillance 

CDRH continues to monitor postmarket product performance through the Center’s 

nationwide reporting system and by conducting applied epidemiologic research. For the last 

quarter of FY 2006, safety analysts identified over 100 new and ongoing medical device 

safety issues. They also responded to over 100 consult requests related to information in 

the reports database. Epidemiologists, in addition to the central role in PAS, participated in 

new and ongoing applied research projects, such as the accuracy of troponin assays (for 

myocardial infarction) and the safety and effectiveness of vertebroplasty. 
 CDRH FY 2006 Annual Report Page 29 

Section 522 Studies 

FDA may order a manufacturer to conduct postmarket surveillance of a medical device 

under section 522 of the Food, Drug, and Cosmetic Act. In FY 2006, CDRH staff 

collaborated with industry sponsors to design science-based Section 522 studies that 

answer important postmarket questions. The Center issued a consolidated guidance 

document for postmarket surveillance, ordered postmarket surveillance for two devices 

(overnight orthokeratology lenses and a coronary vascular anastomosis device), continued 

postmarket surveillance of three critical products, began development of an enforcement 

plan for postmarket surveillance, and issued the first Warning Letter citing postmarket 

surveillance violations under Section 522. 

MedSun 

The Medical Product Surveillance Network (MedSun) plays an important role in postmarket surveillance efforts by connecting CDRH to device users. Hospitals, nursing homes, 

and other healthcare facilities use this interactive Internet-based reporting program to 

report medical device problems. This information helps CDRH, device manufacturers, and 

medical facilities proactively address device safety concerns. 

During the fiscal year, CDRH exceeded by 15 percent its 2006 goal of obtaining a 71 

percent participation rate from the 350 participating user facilities. MedSun expanded to 

include interactive networks that address particular health issues, including LabNet 

(laboratory devices), KidNet (pediatric devices), TissueNet (human cells and tissues), and 

HeartNet (electrophysiology devices, such as pacemakers), and used surveys of network 

facilities to determine the effectiveness of recalls and the training needed to reduce 

adverse events. 

Medical Device Reports 

Medical device reporting is how FDA receives information on significant medical device 

adverse events from manufacturers, importers, and user facilities so that problems can be 

detected and corrected quickly. CDRH received 224,197 medical device reports during the 

fiscal year. 

Report Type Mandatory Reports

(FDA Form 3500A)

Alternative Summary 

Reporting 

Voluntary Reports 

(FDA Form 3500) Totals

Death 2,683 0 147 2,830

Injury 38,349 75,409 2,328 116,086

Malfunction 65,863 29,225 1,397 96,485

Other 7,396 7 1,393 8,796

Totals 114,291 104,641 5,265 224,197
 CDRH FY 2006 Annual Report Page 30 

Compliance and Enforcement 

CDRH risk management actions aimed at preventing harm to the public from regulated 

products include public health notifications, warning letters, and recalls. The following 

actions were taken during FY 2006. 

Enforcement Actions 

CDRH protects the American public by ensuring that manufacturers of medical devices 

comply with Current Good Manufacturing Practice (CGMP) requirements and the Quality 

System Regulation, taking enforcement actions if warranted. During the FY 2006, CDRH 

developed and implemented the Real Time Regulatory Review Process to help reduce 

timeframes so that enforcement actions are processed in a timely manner. 

CDRH improved product quality and the safety of numerous medical devices by taking at 

least 55 enforcement actions during FY 2006 including a corporate warning letter, 4 

seizures, and 1 injunction. 

Warning Letters 

Warning letters are intended to alert a device manufacturer that their product is in violation 

of the laws that FDA enforces. In the letter, the manufacturer is advised to take appropriate 

and prompt corrective action to avoid administrative or regulatory action. In FY 2006, 154 

of the 538 warning letters issued were related to medical devices and radiological health 

(29%). 

Recalls 

Recalls are issued to remove or correct a medical device that violates FDA law. Though 

FDA can order a recall, manufacturers initiate most recalls voluntarily in collaboration with 

FDA. During FY 2006, CDRH initiated 651 recall actions involving 1,550 products. This 

represents approximately a 10 percent increase in recall actions from FY 2005 (571 actions 

involving 1598 products) and includes 143 in vitro diagnostic device recall actions. 

Class Description 

Class I Likely that use of the product will cause serious health problems or death 

Class II Unlikely that use will cause serious health problems, or problems resulting from 

use will be temporary and reversible 

Class III Unlikely that use will cause health problems 
 CDRH FY 2006 Annual Report Page 31 

Recall Actions 

FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006

Class I 29 7 15 7 23 25 21

Class II 344 395 467 460 473 423 500

Class III 122 153 146 141 142 123 130

Totals 495 555 628 608 638 571 651

Expert Witnesses 

The use of experts who provide testimony and certification to the compliance status of firms 

is very important in cases in which the Agency takes regulatory actions. In FY 2006, three 

cases required the services of expert witnesses. Their testimonies were critical to the 

success of these cases processed by the CDRH Office of Compliance. 

Inspection 

Inspection Goals 

CDRH and the Office of Regulatory Affairs (ORA) exceeded the FY 2006 inspection goals 

by at least 20 percent for domestic, foreign, and bioresearch monitoring (BIMO) inspections 

in 

FY 2006: 

 122% (1,299 of 1066) for registered domestic Class II and Class III medical device 

manufacturers; 

 123% (207 of 168) for foreign Class II and Class III medical device manufacturers; 

and 

 120% (336 of 278) for BIMO inspections with an emphasis on scientific misconduct, 

data integrity, innovative products, and vulnerable populations. 

Bioresearch Monitoring (BIMO) Audits and Enforcement Activities 

In addition to compliance with Good Manufacturing Practices (GMP) requirements, industry 

must comply with bioresearch monitoring (BIMO) requirements. BIMO requirements include 

good laboratory practices (GLP) and regulations related to human subject protection and 

data integrity. 
 CDRH FY 2006 Annual Report Page 32 

CDRH collaborates with the Office of Regulatory Affairs (ORA) to conduct data audits to 

determine if devices should be approved. FY 2006 BIMO audit-related accomplishments 

include the following: 

 Issued 24 BIMO Warning Letters and 13 BIMO Untitled Letters to bring noncompliant firms and researchers into compliance with the regulations; 

 Entered into a consent agreement to restrict a device clinical investigator from 

participating in device research; 

 Entered into an agreement to restrict an Institutional Review Board’s ability to 

approve any new FDA-related research; 

 Entered into formal agreements with 3 medical device companies to stop the 

substantive review of their research/marketing submissions until they develop and 

implement corrective and preventive action plans to ensure the integrity of data 

submitted to support their premarket submissions; 

 Identified and analyzed all inspections from the past 6 years with serious violations 

and issued 44 follow-up inspections to confirm whether corrective and preventive 

actions were implemented as promised; 

 Removed four firms from FDA’s Application Integrity Policy list as a result of their 

comprehensive development and implementation of corrective and preventative 

actions to assure human subject protection and data reliability in submissions; 

 Conducted inspections and subsequent analysis that resulted in 2 firms withdrawing 

their pending 510(k)s submissions due to unreliable substantial equivalence 

data/information, and 1 pediatric device sponsor withdrawing its Investigational 

Device Exemption (IDE) for lack of proper oversight and subject safety issues; 

 Conducted 105 data audit inspections, addressed data integrity concerns, and 

issued compliance actions related to 54 active PMAs or PMA supplements; and 

 Received and evaluated 157 allegations of research misconduct that could 

compromise the safety of human research subjects or undermine the quality of 

research data. Evaluation of the allegations resulted in the issuance of 82 

inspections or investigations. 

Approximately 85% of FDA inspections of clinical research with medical devices reveal only 

minor problems with research conduct. To help improve the remaining device research 

that may be problematic, the Division of Bioresearch Monitoring has increased outreach 

activities with regulated industries including study sponsors, clinical investigators, study site 

staff, and Institutional Review Boards plus small businesses through pre-IDE meetings and 

the Office of Orphan Product Development. In addition, staff have published several articles 

in professional journals to improve awareness of proper clinical research practices. These 

outreach activities have resulted in improvements in non-compliance over the past few 

years. 
 CDRH FY 2006 Annual Report Page 33 

Risk-Based Inspection Work-Plan 

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

enforcement actions to improve the regulation and monitoring of the medical device 

industry. In order to utilize resources efficiently, the cross-Center risk-based inspection 

work plan prioritization process was used to identify public health concerns and issued 

special emphasis inspection assignments in three areas: 

 IV Administration Test Kits 

 Internal Cardioverter Defibrillators (ICD) 

 Automatic External Defibrillators (AED) 

Infusion Pump Project 

This project initiated during the fiscal year will transform the way CDRH does business by 

making available the most up-to-date analysis of market share information on the infusion 

pump industry. This project should improve CDRH capability to make informed decisions 

that impact public health and medical necessity. This project also looked at the industry as 

a whole in order to determine areas that need to be addressed. As a result, numerous firms 

came into compliance while others were subject to regulatory action. An initiative to better 

educate the community is planned. 

Evaluation of Inspection Violations 

CDRH conducted a simple analysis of the Turbo EIR (establishment inspection report) 

database and identified the top five reasons violations were issued during a medical device 

inspection. The information will enable CDRH to develop strategies to work with industry to 

address inadequacies and bring firms into compliance. 

Mammography Quality Standards Act (MQSA) 

Congress enacted the Mammography Quality Standards Act (MQSA) to ensure that all 

women have access to quality mammography for the detection of breast cancer in its 

earliest, most treatable stages. FDA was charged with developing and implementing MQSA 

regulations. Examples follow of CDRH accomplishments in advancing mammography 

quality standards during FY 2006. 

MQSA Program Inspections 

CDRH conducted annual inspections at over 8,800 mammography facilities and ensured 

that 98 percent of those facilities met inspection standards with less than 2 percent having 

Level I (serious) problems. CDRH has completed over 104,000 facility inspections 

nationwide since the MQSA program inception. 

MQSA Enforcement Actions 

An Additional Mammography Review (AMR) is performed in cases where FDA or the 

Certifying State has reason to believe that mammography quality has been compromised 

and may present a serious risk to human health. CDRH has performed 80 AMRs since the 

MQSA program began. 
 CDRH FY 2006 Annual Report Page 34 

Although not a regulatory action, an AMR occasionally results in a regulatory action, such 

as a Patient and Physician Notification (PPN). A PPN explains the problem found to 

patients and referring physicians and outlines actions to take to reduce related health risks. 

If an accreditation body revokes a facility’s accreditation, FDA may conduct an investigation 

to determine the reasons for the revocation and may determine that the facility’s certificate 

shall no longer be in effect. A facility whose certificate is no longer in effect because it has 

lost its accreditation may not legally practice mammography. 

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

During the FY 2006, CDRH completed several regulatory actions against mammography 

facilities including one Patient and Physician Notification (PPN) and one instance where 

FDA declared a facility’s MQSA certificate no longer in effect.

Collaborations 

Through increased collaboration with external partners, CDRH is enhancing its ability to 

identify, analyze, and act on postmarket information, and improve enforcement strategies 

and outcomes. 

Software Forensics Laboratory 

In consultation with other federal agencies involved with software integrity issues (e.g., 

Department of Defense, FBI, National Institute of Standards and Technology, NASA), the 

CDRH Software Forensic Laboratory leveraged the latest academic research to implement 

a state-of-the-art software forensic capability during 2006. This capability may be used in 

any phase of the product life cycle, but is particularly valuable in understanding the root 

causes of adverse events due to software failures. In 2006, this new capability was used to 

the great benefit of the Center in several high-profile compliance cases. Ultimately, such 

tools will increasingly be used by medical device manufacturers in their own product 

development phase, thereby reducing the frequency of software defects and the incidence 

of adverse events and product recalls. 

Defibrillator Working Group 

CDRH established the Defibrillator Working Group to coordinate pre- and post-market FDA 

activities for implantable and external defibrillators. The working group addressed specific 

processes related to the regulation of defibrillators and collaborated with the Heart Rhythm 

Society and AdvaMed to assure a full perspective on the issues. The working group piloted 

a model for effective communication across the entire device life cycle. 

Agency for Healthcare Research and Quality 

CDRH continued several collaborations with the Agency for Healthcare Research and 

Quality (AHRQ) which administers several datasets 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. Although similar studies have 
 CDRH FY 2006 Annual Report Page 35 

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. 

Interagency Registry for Mechanically-assisted Circulatory Supports (Intermacs) 

This effort aims to capture detailed clinical data on all patients receiving ventricular-assist 

devices for destination therapy. The effort is funded by NIH, requires facilities to meet 

Centers for Medicare and Medicaid Services (CMS) standards to receive reimbursement, 

and accommodates FDA needs for active surveillance and post-approval studies of these 

devices. http://www.intermacs.org/

e-Bay and the Federal Trade Commission (FTC) 

CDRH continued grass root and collaborative efforts with e-Bay and the Federal Trade 

Commission (FTC) to ensure that unapproved products were removed and not offered for 

sale on the e-Bay website. 

Global Harmonization 

The market place for medical devices is global—40 percent of approved device firms have 

manufacturing facilities abroad while 6,000 overseas establishments export devices to the 

United States. CDRH plays an important role supporting global harmonization activities 

including assisting foreign manufacturers to comply with U.S. medical device regulations. 

As part of the effort to minimize burden to industry, CDRH participates in the development 

of international as well as national product standards. 

Health Canada 

In September 2006, CDRH and Health Canada announced a pilot multi-purpose audit 

program (PMAP). The purpose of the pilot, slated to begin in 2007, is to evaluate the 

effectiveness of performing a single third party inspection/audit of medical device 

manufacturers' quality systems that would meet the needs and regulatory requirements of 

both countries. 

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

International Organization for Standardization (ISO) 

The International Organization for Standardization (ISO) is the world's largest developer of 

standards. ISO standards are designed for implementation worldwide and include 

requirements for medical devices. 

During FY 2006, CDRH participated in the ISO Technical Committee 94, Workgroup 4 

(WG4), meeting in Chicago, Illinois to discuss and revise the draft standard for Clinical 

Investigation of Medical Devices for Human Subjects. The Workgroup voted to advance the 

standard for further review within the ISO. CDRH collated the comments of FDA 

representatives and other U.S. participants for the WG4 Editing Committee in an 11-page 

document to ensure that the comments were included in the final work product. 
 CDRH FY 2006 Annual Report Page 36 

Global Medical Device Nomenclature 

The Global Medical Device Nomenclature (GMDN) is an international standard for naming, 

defining, and coding medical device groups to ease identification of products worldwide and 

reduce confusion when investigating device-related problems. CDRH has contributed 

considerably to administration and technical maintenance of the standard such as 

promoting improved nomenclature practices for better data management and efficient 

communication of data with international regulatory partners. 

Global Harmonization Task Force (GHTF) 

The Global Harmonization Task Force (GHTF) is an international member organization 

dedicated to fostering convergence of medical device regulatory practices worldwide while 

ensuring the quality, safety, and effectiveness of medical devices. GHTF members also 

work to promote technological innovation and facilitate international trade. In FY 2006, 

CDRH actively participated in the work of 5 GHTF Study Groups: 

 Study Group 1 – Regulatory and Premarket Requirements 

 Study Group 2 – Postmarket Vigilance 

 Study Group 3 – Quality Systems 

 Study Group 4 – Regulatory Auditing of Quality Systems 

 Study Group 5 – Clinical Evidence 
 CDRH FY 2006 Annual Report Page 37 

FDA Goal 4—Transforming FDA Business Operations, 

Systems, and Infrastructure to Support FDA's Mission in 

the 21st Century 

CDRH is integrally involved in FDA-wide efforts to create a stronger, more unified Agency. 

The increasingly complex regulatory mission of the FDA requires improved business 

practices to create efficiencies, standardize processes, enhance infrastructure, and 

improve planning. CDRH FY 2006 efforts to augment FDA’s mission in the 21st Century 

included IT enhancements, development of an operational plan, expanded training for staff, 

and attention to homeland security. 

CDRH Management 

Efficient and effective management is necessary to support CDRH programs. 

Medical Device Postmarket Transformation Initiative 

Assuring the postmarket safety and effectiveness of medical devices which may remain in 

use for 10–20 years is a daunting task. In January 2006, as the result of an internal review 

of CDRH postmarket tools and processes, the Center issued a comprehensive report on 

the Medical Device Safety Program. In response to the report, the Center convened a 

Postmarket Transformation Leadership Team (PTLT) composed of CDRH senior staff and 

external medical experts to consider recommendations to make the Center’s postmarket 

program more comprehensive and timely. The recommendations focused on four areas 

designated for improvement: 

 Create a culture of collaboration to improve joint efforts within and without the Center 

to identify and solve postmarket problems; 

 Develop world class data sources and systems to more rapidly recognize, analyze, 

and track device usage problems; 

 Enhance risk/benefit communication efforts to quickly and clearly share postmarket 

information with practitioners, patients, and consumers; and 

 Increase collaboration to improve enforcement strategies and outcomes. 

The PTLT met several times from January to September 2006, recommending actions 

under each area and suggesting next steps to achieve postmarket transformation. 

CDRH Operational Plan 

The Center concluded FY 2006 with development of a CDRH operational plan. The 

purpose of the plan is to provide the Center with a roadmap aligning CDRH’s strategic 

goals with those of the FDA. CDRH is the first among FDA centers to develop a 
 CDRH FY 2006 Annual Report Page 38 

comprehensive, strategic operational plan linking mission to objectives, actions, and 

performance measures. 

Communications Improvement Initiative 

During the fiscal year, CDRH conducted an evaluation of internal communications 

processes. Interviews and focus groups with management and staff were used to identify 

processes working well and areas needing improvement. CDRH is evaluating 

recommendations to determine a workable plan for improving Center-wide 

communications, and to support CDRH and FDA external communications goals. 

IT Enhancements 

IT systems allow for better tracking and monitoring of medical devices throughout the total 

product life cycle. CDRH continued working in FY 2006 to ensure that IT projects are 

consistent with the Center’s strategic goals and priorities. Efforts to map out 60 business 

processes and determine cross-cutting functions and IT support needs contributed 

significantly to development of the first CDRH IT Strategic Plan. 

IT enhancements initiated during FY 2006 included systems development for submissions, 

review, and tracking. 

Electronic Submissions 

 FURLS 

In support of the Expanded Electronic Government Initiative of the President’s 

Management Agenda (PMA) and information collection requirements of the 

Bioterrorism Act, CDRH completed the design phase and began implementation of 

the FDA Unified Registration and Listing System (FURLS). FURLS will allow for 

electronic submissions from industry and result in significant savings for CDRH in 

contract costs. 

 CeSub eSubmitter 

After a very successful pilot program for the in vitro diagnostic device industry [Turbo 

510(k)] and for the electronic product industry (eRadHealth), CDRH improved 

submission software to produce a new e-tool called CeSub eSubmitter. CeSub 

eSubmitter is free software that allows sponsors to complete and submit 

submissions electronically. Since the roll out of the CeSub software applications, 

CDRH has received well over 100 IVD 510(k) submissions, almost entirely from new 

companies, as well as over 100 electronic product submissions. 

To increase electronic product industry use of the CeSub software, CDRH is 

enclosing a CeSub flyer with acknowledgement letters sent in response to reports 

received from industry. Manufacturers are also referred to the CDRH website for 

information on how to comply with requirements and encouraged to download the 

software. 
 CDRH FY 2006 Annual Report Page 39 

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

During FY 2006, CDRH also increased the number of electronic submission 

templates for the Radiological Health Program. 

Industry can now submit applications electronically for a larger number and variety of 

products. Electronic submissions improve the review process and result in reduced 

costs and time for both industry and the FDA. 

 Rad Health Processor (RH Pro)

CDRH began development of an electronic document processing system, RH Pro, to 

replace the legacy data system used since the beginning of the radiological health 

program. RH Pro facilitates storage and management of both scanned paper and 

electronically submitted reports and correspondence on electronic products and 

manufacturers.

 eCopies Program

CDRH initiated the eCopies program to encourage sponsors of premarket medical 

device submissions to include a copy of their submission in the prescribed electronic 

form along with the required paper copies. During the fiscal year, 2,374 premarket 

submissions (2,376,036 pages) were scanned off site and received through the FDA 

Gateway. 

Electronic Review 

 Documentum

As part of FDA commitment to improve procedures and move toward an e-government 

environment, CDRH is shifting from paper to electronic review. CDRH participated in the 

development of Center-wide procedures for use of the software Documentum for the review 

of Premarket Approval Applications and provided training to reviewers and consulting 

reviewers to ensure uniform implementation. Further, procedures were developed to allow 

electronic archival and review of electronic product Radiation Safety Reports. CDRH also 

participated in a Business Process Improvement initiative to map out the current review 

process and propose options to improve the review process by integrating electronic review 

tools. 

Electronic Tracking 

 Export Certificates

CDRH began planning an electronic program for processing and issuing export certificates. 

On average, CDRH produces 2,280 certificates per month. 

 Center Tracking System (CTS) 

FDA Office of the Commissioner and FDA Office of Combination Products began use of the 

CDRH Tracking System (CTS) for managing/tracking combination products requests for 

designation (RFD). CDRH also deployed enhancements to CTS to support business 

processes and rules across the total product life cycle of medical devices. In addition, the 
 CDRH FY 2006 Annual Report Page 40 

Center completed enhancements to the device nomenclature management system (DNMS) 

and completed development of the electronic consultations tracking (eConsult) module of 

CTS. 

The tracking capabilities provided by CTS, electronic document archival provided by 

Documentum, and the electronic submission and control capabilities provided by CeSub and 

RH Pro will provide a paperless document control and review process for electronic product 

submissions. 

 Compliance Operations and Program Support System

CDRH implemented the first phase of the Compliance Operations Program Support (COPS) 

workflow management system and integrated it into the Center Tracking System (CTS). The 

new COPS-CTS component will track regulatory actions and their outcomes and will 

improve workflow management and tracking capabilities. 

 Premarket Modernization Program (PMP) 

CDRH initiated the Premarket Modernization Program (PMP) to update and optimize access 

to CDRH’s data through the creation of a total product life cycle (TPLC) data warehouse. 

Initially the warehouse will be loaded with premarket data, but it is designed to eventually 

include postmarket and compliance data. 

 Electronic Medical Device Reporting 

CDRH initiated development of a program to modernize the data entry process for adverse 

events and for accepting and processing electronic adverse event reports (eMDR) using the 

Health Level Seven Individual Case Safety Report (HL7 ICSR) message format. This will 

allow for more rapid transfer of adverse event reports to the clinical analyst for review and 

possible action. When the system is fully produced, implemented, and used by the 

manufacturing firms, it will reduce data entry costs by over 50 percent. 

 Postmarket Studies Tracking 

CDRH worked with a contractor to develop the Conditions of Approval tracking database for 

all post approval studies January 1, 2005, and forward. The database automatically keeps 

track of due dates; the status of studies will be placed on a web posting for the public. 

Training CDRH Staff 

Recruiting and training of scientists and health professionals in technologies is crucial for 

CDRH to accomplish its public health mission and to create and maintain an excellent 

workforce. Training and continuing education for CDRH staff is also important to enhance 

job performance and maximize career potential. 

Staff College

Seven hundred thirty-six (736) CDRH employees attended 2,333 Staff College courses—

an average of 3 courses per employee. The Staff College presented 126 different courses: 

17 percent in law and policy, 36 percent in science, 29 percent in professional 

development, and 18 percent in leadership. 
 CDRH FY 2006 Annual Report Page 41 

New Employee Orientation Program 

Gateway to Success is CDRH’s orientation program for new employees. Administered by 

the Office of Communication, Education, and Radiation Programs (OCER) Staff College, 

Gateway to Success consists of several program components. 

 The New Employee Toolkit is a hard copy resource given to new employees on their 

first day in CDRH. The toolkit contains an overview of Gateway to Success, 

background information on CDRH, a map of CDRH facilities, a new employee 

checklist, and contact information. 

 The Peer Guide Program pairs new employees with more seasoned employees who 

are equipped to answer questions and share information about their experiences at 

CDRH. Peer guides are provided with the brochure CDRH Peer Guides: Tips for 

Communicating with Your Assigned Peer. 

 Discovery Portal is an online portal accessed through the Staff College’s Learning 

Management System. The website has links to both FDA and CDRH administrative, 

personnel, and organizational information; a repository of forms; facility maps; and a 

checklist for new employees. 

 Gateway to Success resources for supervisors include Supervisor Checklist for 

Welcoming New Employees and Supervisor Talking Points for Meeting with New 

Employees. 

 Gateway to Success classroom training includes interactive exercises and dialogue 

designed to help new employees reflect on their first few months as a CDRH 

employee and understand their role relative to CDRH’s mission. The training also 

provides guidance on career development at CDRH. 

Competency Development Program 

During FY 2006, CDRH implemented a voluntary Competency Development Program for 

staff. The program is based on nine core business and science competencies: 

 Communication 

 Computer skills and knowledge 

 Critical thinking 

 Ethics and integrity 

 Medical and radiation products and devices 

 Organizational knowledge 

 Scientific, medical, and radiation terminology 

 Teamwork 

 Time management 
 CDRH FY 2006 Annual Report Page 42 

The Competency Development Program will help CDRH managers assess staff needs and 

pinpoint training and development opportunities to equip staff to achieve the mission and 

goals of CDRH. 

CDRH Leadership Programs 

During FY 2006, CDRH continued to develop the skills of existing leaders and foster the 

growth of the next generation of Center leaders. CDRH leadership programs offer senior 

staff executive coaching opportunities and annual 360 degree feedback. Motivated, highly 

skilled non-managerial staff are competitively selected to participate in the Center’s 

Leadership Readiness Program. 

Educational Broadcasts 

The Division of Communications Media (DCM) within CDRH’s Office of Communication, 

Education, and Radiation (OCER) Programs produces satellite broadcasts and video 

productions for diverse clientele in the federal government and the private sector. During 

FY 2006, DCM provided 8 hours of mission-related programming every day to CDRH 

employees via the CDRH fiber-optic network, including 37 educational and training 

programs received live via satellite and delivered simultaneously. They also produced 18 

teleconferences for FDA and other government agencies on a wide variety of topics. 

http://www.fda.gov/cdrh/ocer/dcm/

Homeland Security 

CDRH’s accomplishments play a critical role in securing the homeland and protecting the 

public from excessive radiation exposure and radiological terrorism. 

Radiological Counterterrorism and Radiation Safety 

During FY 2006, CDRH consulted with fellow FDA Centers, and state and federal partners 

to address radiation safety of security screening and defense products. 

 CDRH participated in measurement instrument testing with the Transportation 

Security Administration (TSA) and helped revise radiation safety training that TSA is 

preparing for its security staff working with security screening products. 

 CDRH participated in the Interagency Steering Committee on Radiation Standards 

(ISCORS) to develop a federal guidance entitled Guidance for Security Screening of 

Humans Utilizing Ionizing Radiation. 

 CDRH worked with the Federal Aviation Administration (FAA), the Department of 

Homeland Security (DHS), the Department of Defense (DoD), and industry 

representatives to evaluate the safety of air-based and ground-based laser antimissile defense systems to protect commercial air traffic. 
 CDRH FY 2006 Annual Report Page 43 

Emergency Preparedness 

 Hurricane Response Assistance 

 CDRH deployed five staff members to assist with FDA’s efforts in response to 

Hurricanes Katrina, Rita, and Wilma. In addition, CDRH emergency team members 

actively participated in operations to supply regulatory and other helpful medical 

device and safety information for use post hurricane to FDA’s Emergency 

Operations Center (EOC) and ultimately to emergency personnel, public health 

professionals, and consumers. 

 Rapid Response Team to Combat Pandemic (Avian) Flu 

In response to the emerging threat of pandemic (avian) influenza, FDA announced 

the formation of a Rapid Response Team. In the event there is an avian flu outbreak 

in the United States, the team, including representatives from CDRH, will assist in 

locating and monitoring stockpiles of medical devices that will be in high demand but 

may be in short supply. In addition, the Rapid Response Team will work collectively 

with other healthcare centers and FDA’s Office of Counterterrorism Policy and 

Planning (OCTTP) to resolve regulatory policy issues that may occur prior to and 

during an influenza pandemic.