Department of Health and Human Services
Food and Drug Administration
Fiscal Year 2005

MEDICAL DEVICES AND RADIOLOGICAL HEALTH

Historical Funding and FTE Levels

MISSION

The Devices and Radiological Health program promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.  The aim of the program is to:  

• Meet all statutory responsibilities for review of new medical devices;
• Assure medical product safety by monitoring the use of all medical devices, and the function and use of radiological health;
• Manage emerging hazards to prevent widespread health and safety threats and ensure safe and effective new technologies;
• Apply the Total Product Life Cycle model across the range of Devices and Radiological Health activities, by covering products from concept to obsolescence;
• Connect to the global public health community, and partner with stakeholders;
• Use science in the regulatory process to the maximum extent;
• Attract and retain a diverse and high quality workforce; and,
• Measure and set targets to program's impact on public health.

BACKGROUND

CDRH regulates a wide array of medical devices, from artificial hearts, pacemakers, and drug-coated stents; to deep brain stimulators and spinal implants; dialysis machines and infusion pumps; intraocular lenses and cochlear implants; robotic surgery devices and stair-climbing wheelchairs; to in vitro diagnostic devices, radiologic devices and many others. To keep pace with the rapid development of new technology, and to make decisions based on the best scientific information and knowledge available, CDRH routinely consults with experts in the academic community, other government entities, clinical practice, and the military. CDRH also supports initiatives to improve the Nation's ability to respond to bioterrorism and public health challenges. Many of these counterterrorism activities include expediting review of Bioterrorism diagnostics, managing product shortages, supporting safe and effective development and use of battlefield and emergency devices, and ensuring safe use of people scanners in airports and other security systems, and assessing radiation products for misuse as weapons.

The Field component, the Office of Regulatory Affairs (ORA) supports the Center for Devices and Radiological Health. ORA conducts preapproval inspections of both foreign and domestic establishments and other premarket-related activities such as: bioresearch monitoring of clinical research; preapproval inspections and laboratory method validations needed for premarket application decisions, and inspections of manufacturing facilities to determine if the factory is able to manufacture the product to the specifications stated in the application. The Field also conducts risk-based domestic and foreign postmarket inspections of medical device manufacturers to assess their compliance with Good Manufacturing Practice requirements to include inspections of reprocessors of single-use devices.  ORA also monitors imported medical devices and radiological products through field examinations or sampling, as needed, to ensure the safety of such products.

In addition to overseeing regulated products on a surveillance or "for cause" basis when a problem is encountered, ORA staff also responds to emergencies and investigates incidents of product tampering and terrorist events or natural disasters that may impact FDA regulated goods. To complement the regular field force, the Office of Criminal Investigations investigates instances of criminal activity in FDA regulated industries.

Device and Radiological Health Program Increases for FY 2005
By FDA Strategic Goal

PROGRAM RESOURCE CHANGES

Budget Authority

Medical Device Review: + $25,555,000 and + 50 FTE

The requested increase in appropriated funding will provide the resources needed to allow FDA to reach the required appropriation level for FY 2005 under the Medical Device User Fee and Modernization Act (MDUFMA).  This increase in budget authority, coupled with the user fee funds collected for the review of medical device applications, will enable FDA to meet the aggressive premarket performance goals committed to under the legislation.  This involves expediting review times which will support our agency wide initiative to make innovative medical technologies available to the public sooner, and helping to reduce the costs of developing safe and effective medical products while maintaining FDA's high standards of consumer protection.  The FY 2005 funds will give FDA the capability to build towards the future so that it can begin meeting the performance commitments for FY 2006 and 2007. The additional funds will be used to:

• Cover the cost of living increases with $3,900,000 so that FDA can maintain staffing levels and scientific capabilities to meet the demands of an increasing workload and new challenges.  Overall, payroll accounts for over 60 percent of the Agency's total budget. Cost of living increases are necessary to ensure that FDA has adequate staff to meet its Medical Device program goals; 
• Enhance the IT systems that support the current premarket review process.  This includes modernizing all premarket systems and replacing the outdated and inadequate legacy IMAGE system with the updated IMAGE 2000 scanning system.  The new system will allow FDA to continue to scan documents, such as predicate 510(k)s, and reduce the scanning backlog so that the documents are readily available to FDA's review staff, which will help FDA perform high-quality reviews more rapidly.  FDA will also develop system capabilities to facilitate the submission and acceptance of electronic premarket applications; 
• Enhance reviewer training and skill maintenance so that FDA reviewers are able to understand and keep pace with the device technologies that are rapidly developing and becoming more complex.  This includes contracting with outside expertise to provide support and training to FDA review staff on a variety of rapidly changing, increasingly complex technological issues, such as innovative new medical procedures and treatments and statistical methods;
• Employ research and science based activities that provide support critical to the device product approval process;
• Invest in office and laboratory infrastructure to keep pace with rapid technological and scientific change in the diverse fields of expertise that contribute to effective review and oversight of medical devices;
• Recruit and contract with subject matter experts to help develop guidance and standards to help industry understand and meet FDA requirements, to prepare and disseminate information on how FDA will regulate emerging technologies, and to help support FDA's role in international harmonization on emerging technologies.  It is necessary for these documents to reflect the complexity of emerging technologies such as nanotechnology, robotics, and demographic developments; 
• Expand FDA's small business assistance program as required by the FD&C Act.  Approximately 35 percent of the PMAs approved last year were from first time submitters who needed FDA's assistance to understand the statutory and regulatory requirements that must be met, and the scientific, technical, and clinical information requirements that must be provided in an application;
• Conduct pre-approval inspections for device manufacturers;
• Enhance policy and guidance document development, emergency response, review management and risk communication for products developed and used to respond to terrorist threats and national security crisis; and,
• Contract with professional societies to determine staffing and equipment needs for headquarters, centers and field labs, and to plan bio-effects research, and collaborate with Federal agencies and states to develop safe use requirements.

User Fees

Medical Device User Fee and Modernization Act (MDUFMA):  + $1,237,000 and     + 17 FTE

Sound, risk based review processes are imperative to ensure that medical devices on the market are safe and effective.  To strengthen FDA's medical device review process MDUFMA was authorized in FY 2002 as a multi-year effort to improve the quality and timeliness of the medical device review process.  The user fees supplement the appropriated portion of the medical device review program, and will allow FDA to continue the following efforts:

• Acquire and train staff to meet a set of aggressive performance goals for expediting the review of medical device applications;
• Promote public health with major improvements in the review of expedited submissions for medical devices; and,
• Make major improvements in review performance in areas where fees are collected, while maintaining performance in other areas.

Mammography Quality Standards (MQSA): + $339,000

Breast cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among American women.  Experts estimate that one in eight American women will contract breast cancer during their lifetime.  The MQSA was signed into law in 1992 to address the public health need for safe and reliable mammography.  The Act required that mammography facilities be certified by October 1994 to be able to remain in operation, and inspected annually to ensure compliance with national quality and safety standards.  The MQSA Program certifies mammography facilities and performs annual inspections to ensure that women have access to safe and effective mammography services.  MQSA was not reauthorized by the 107^th Congress because of concerns about the need to improve the skills of physicians reading mammograms and the need for interpretive skills assessment to be added to existing MQSA continuing medical education requirements.  The FDA has been working with congressional staff to address these concerns.  The fees collected pay for the costs of the annual inspections to ensure compliance with national quality standards.  The increase of $339,000 will cover inflation.

PROGRAM ASSESSMENT RATING TOOL (PART)

In the FY 2004 review, FDA was assessed as five distinct programs (Foods, Human Drugs, Biologics, Veterinary Medicine, and Medical Devices and Radiological Health) and was rated as "results not demonstrated" due to a lack of long-term outcome goals.  To address this concern, long-term outcome goals were developed.    

For FY 2005, the Office of Management and Budget conducted a second program review that treated FDA as a single agency program.  In this review, FDA received a rating of "moderately effective" and score of 77 percent, up from 59 in FY 2004.  This was due to considerable improvements in developing long-term agency-wide outcome goals that will demonstrate its effectiveness and impact on the public health.  FDA also reduced the number of performance goals, and made various management improvements that further streamline its infrastructure while supporting core, mission-critical public health activities. 

The Devices and Radiological Health Program shares in an agency-wide outcome goal of reducing administrative overhead through the reduction of the number of administrative staff.  All of the Agency's outcome goals support the Department's priorities and Administration's initiatives with the intent to improve the health and well-being of the American public. 

JUSTIFICATION OF BASE

EFFICIENT RISK MANAGEMENT:  THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY BUCK

FDA will use science-based risk management in all Agency regulatory activities so that limited resources can provide the most health promotion and protection at the least cost for the public. Efficient risk management efforts for FDA's medical device program are detailed below:

Statutory Device Review Times

Medical devices intended for human use have premarket applications that must be properly processed within statutorily required time frames.  These functions support the Department's priorities to accelerate private sector development of new medical technology.  In addition, MDUFMA commits FDA to significant improvements in device review performance.  The industry is relying on FDA to take a leadership role in regulating a rapidly emerging frontier of medical device technology with timeliness, quality, scientific consistency, and international harmonization.  With the MDUFA appropriated and user fee resources, FDA will be able to:  

• Reduce the average time for marketing approval for safe and effective new devices and aim to make the greatest reduction in time to market for breakthrough products, in conjunction with the MDUFMA program.  FDA needs to make these improvements in order to successfully implement MDUFMA;
• Improve the device review program by reducing multi-cycle reviews; and,
• Work with stakeholders to make premarket applications more complete.

Third Party Review Program

Third Party 510(k) Reviews are consistent with FDAMA's intent to encourage the use of outside scientific and technical expertise and provide an alternative to FDA review. In addition to being faster than reviews performed exclusively by FDA staff, this option can give manufacturers access to specialized expertise by third parties in areas such as device testing, standards, and foreign regulatory requirements.  FDA will:

• Conduct activities that encourage industry's use of third party reviews - sixty-five percent of all 510(k)s are eligible for third party review;
• Maintain FDA's third party web site, which provides information on the Accredited Persons Program; and,
• Maintain the Third Party Review Board to advise and assess new applicants, reassess existing Accredited Persons that seek to modify their scope of work, and monitor FDA's periodic auditing of their work.

Import Monitoring and Inspections

FDA must maintain inspection coverage for both domestic and foreign medical device manufacturers.  Although medical devices have become more medically and technologically complex and the device industry is growing at home and abroad, the device and radiological health inspection resources have not kept pace with the growth.  In the area of import monitoring and inspection FDA will:

• Use risk management to target inspection coverage for Class II and Class III device manufacturers at 20 percent of the estimated 5,550 high-risk device domestic statutory inventory.   This coverage goal does not include any inspections conducted under the "Inspections by Accredited Persons Program"
• Inspect nine percent of the 2,500 foreign Class II and Class III high-risk statutory inventory firms;
• Conduct criminal investigations of reported product tampering, counterfeit products, and other fraudulent criminal activities involving FDA regulated products;

• Conduct emergency operation activities, investigations, and respond to incidents involving FDA regulated products;
• Review approximately 3,100,000 device import lines for admissibility into domestic commerce;
• Conduct virtual training for foreign firms to assist in their efforts to voluntarily comply with FDA requirements; and,
• Conduct import field examinations of imported latex products. 

Inspections by Accredited Persons

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorizes the Agency to accredit third parties (Accredited Parties or AP) to conduct inspections of eligible manufacturers of Class II and Class III medical devices.  FDA issued guidance to implement the new section 704(g) of the Federal Food, Drug, and Cosmetic Act.  The Inspections by Accredited Persons Program will be conducted independent of third party inspections performed under the current US/EC Mutual Recognition Agreement.  

• Approximately 48 representatives from 15 AP firms attended an FDA sponsored classroom training program in January 2004.  This training will be followed by individual training inspections conducted with FDA Performance Auditors.  The Accredited Parties will then be ready to conduct independent inspections of FDA regulated establishments; and, 
• Prepare and publish new draft guidance for establishments participating in the Accredited Parties program.  FDA will not be able to estimate the impact of this new program on FY 2005 inspection coverage until the FDA regulated establishments have applied and been approved to participate in the program. 

Human Subject Protection

One of the Department's strategic goals is to enhance the capacity and productivity of the Nation's health science research enterprise by strengthening the mechanisms for ensuring the protection of human subjects and the integrity of the research process.  An effective, comprehensive Bioresearch Monitoring program is essential for the expeditious development and approval of safe and effective products and to ensure research subject safety. The Agency continues to leverage scientific capabilities in order to respond and contribute to major breakthroughs in medical device research and technology via continued professional development/ training, and continued stakeholder collaborations.  Some of the new high-risk technologies under active human subject research include:  implantable cardiac defibrillators, in vitro diagnostic devices that help detect/identify biothreat agents, an artificial heart, and drug-eluding stents.  The human subject protection program will:

• Ensure prompt follow-up to bona fide complaints of research misconduct that may compromise the safety of human research subjects or subvert regulatory review;
• Conduct Bioresearch Monitoring inspections and data audits in the medical device area to monitor the methods and reporting of FDA regulated research;
• Inspect clinical investigators to protect the rights and welfare of human and animal subjects involved in FDA regulated research, and to assure the quality and integrity of data submitted to the Agency in support of new product approvals; and,
• Educate the device research community and maintain professional development of Agency staff to keep pace with clinical research in evolving and breakthrough device technologies.

Device Reuse

Before enactment of MDUFMA, the regulatory requirements for manufacturers of reprocessed single use devices basically depended upon the class of the device.  Manufacturers of reprocessed class I and II single use devices (the persons who are reprocessing the device) were required to obtain premarket notification clearance (510(k)), unless the device was exempt from 510(k).  Reprocessors of class III devices were required to obtain premarket approval (PMA).  Under the new law, reprocessors of some exempt devices will no longer be exempt from the 510(k) submission requirements but rather will need to submit 510(k)s that include validation data including cleaning and sterilization data, and functional performance information demonstrating that each reprocessed single use device will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the 510(k). Validation data also will be required for many reprocessors of single use devices that are currently the subject of cleared 510(k)s.  Finally, reprocessors of class III devices will need to submit a premarket report (a new type of premarket application).   FDA will:

• Publish a Federal Register notice identifying semi-critical reprocessed single use devices. These devices are intended to contact intact mucous membranes and not penetrate normally sterile areas of the body, which under the new law will require a 510(k) in order to ensure their substantial equivalence to predicate devices;
• Enforce the labeling requirement that all reprocessed single use devices must "prominently and conspicuously" bear the statement "Reprocessed device for single use;
• Publish guidance documents that:  Provide specific information about the types of validation data that should be submitted in a 510(k) for reprocessed single use devices listed in the Federal Register notice and explains how a single use device 510(k) holder may submit the additional data now required by the new law;
• Inspect up to 100 hospitals annually to evaluate their compliance with premarket clearance requirements and the requirements of the Quality System Regulation; and,
• Determine whether FDA should regulate the practice of resterilizing opened-but-unused single use devices, based on informed comments from health care professionals and organizations, industry and other interested parties concerned about this practice.

Bovine Spongiform Encephalopathies (BSE)/Transmissible Spongiform Encephalopathies (TSE)

BSE, widely known as "Mad Cow Disease", is a deadly chronic, degenerative disorder affecting the central nervous system.  Feed containing remnants of the slaughtering process, such as the brain and spinal cord, may harbor the agent that causes BSE.  TSE is includes as group of human and animal diseases for which there are no treatment or preventive vaccines and are fatal to humans and animals.  FDA will:

• Revise Field Investigator's Guidance for Manufacturing Facilities;
• Maintain a device tracking/animal materials for identifying/tracking devices containing or manufactured from animal-derived source material;
• Examine ways to prevent the transmission of TSE-related diseases through the use and reuse of medical instruments;
• Hold public workshops to engage all interested parties in addressing the issue of decontamination of devices exposed to potential TSE disease infectivity; and,
• Evaluate decontamination procedures for device manufacturing processes, including equipment and facilities and decontamination procedures for medical instruments.

International Activities

The increase in device imports and the difficulty in inspecting the majority of foreign medical device establishments has resulted in a public health need to fully implement the U.S./European Community (EC) Mutual Recognition Agreement (MRA).  A successful MRA will help reduce the number of foreign firms FDA staff needs to inspect, while relying on FDA inspections conducted by listed European Unions (EU) Conformity Assessment Bodies (CABS).  FDA will:

• Implement the pilot program on an internationally harmonized format in the review of submissions for device safety and performance.  The pilot is identified as the STED initiative;
• Develop and maintain information about EU-based medical device manufacturers and provide more information about the status of those manufacturers to help expedite product approval;
• Maintain FDA's international inspection program to help ensure that all imported FDA regulated products meet the same standards as domestic goods; 
• Continue FDA's participation as a member of the Global Harmonization Task Force; and,
• Develop a mechanism for recognizing symbols for use in In Vitro Diagnostic Labeling to allow for harmonization of package inserts in a concise manner.

Genetic Testing

The vast majority of genetic tests are currently not regulated by FDA.  The Secretary's Advisory Committee on Genetics Testing recommended increased oversight of genetic testing.  FDA participates with the CDC and other agencies to:

• Develop scientific expertise and regulatory strategies for evolving medical device areas such as genetic testing; and,
• Collaborate with other DHHS agencies as part of an inter-agency working group and as a participant with the CDC on genetics testing;

Clinical Laboratory Improvement Amendments (CLIA) 

This activity is funded by a portion of the CLIA user fees collected by the Centers for Medicare and Medicaid Services.  FDA collaborates with CMS to:

• Categorize commercially marketed in vitro diagnostic test systems; and,
• Determine which in vitro diagnostic test systems can be placed in the waived category under CLIA.

Information Technology

• eRadHealth:  The eRadHealth system will allow manufacturers to submit radiation documentation in electronic format, provide risk management prioritization of data, provide trend analyses, and allow data sharing with States and the public.  It will permit more efficient use of FDA resources and industry-wide corrections of product safety problems; and,
• Image2000 Document Management System:  The Image2000 Document Management System assists in premarket review and related document-management activities such as archiving and FOI redaction.

EMPOWERING CONSUMERS:  IMPROVING HEALTH THROUGH BETTER INFORMATION

Information Technology

• Mammography Program Reporting and Information System (MPRIS): The Mammography Program Reporting and Information System, is a state-of-the-art information management system that supports implementation of MQSA. MPRIS will improve the quality, reliability, integrity, and accessibility of facility certification, inspection, and compliance data.  The system also tracks and monitors the accreditation, certification, inspection, and compliance history of facilities.

IMPROVING PATIENT AND CONSUMER SAFETY

Another important function of FDA is to identify risks associated with the use of medical products and reduce the occurrence of adverse events.  The enhancement of the adverse events data system and linkages with other health care systems is the first line of defense against medical errors.  The following activities support the Department's initiative to improve the quality of health care services:

• Increase the enrollment to 250 facilities in the MedSun, a postmarket surveillance system designed to reduce device-related medical errors, serve as an advance warning system, and create a two way communication channel between FDA and its system participants.  This will be accomplished by recruiting a few new facilities and replacing those facilities that choose to rotate out of the system.  FDA will use these facilities to determine the effectiveness of various incentives; the use of facilities as laboratories to obtain specific medical product information; and, pilot various types of feedback to encourage facility reporting;

• Expand the lab-reporting project to target surveillance, initially piloted in FY 2003 and FY 2004 into all agreeable MedSun sites.  Expansion of the lab-reporting project will allow FDA to evaluate procedures for collecting data on problems with laboratory tests and the feasibility of including hospital laboratory staff;
• Expand distribution of "FDA Patient Safety News" (FDA PSN), a monthly television news show that communicates FDA's patient safety messages to the health care community.  This major agency-wide effort brings vital information on how to improve the safety of medical products to health professionals across the nation.  FDA PSN can already be seen in about 4,500 hospitals and nursing homes across the U.S. several times each month via medical satellite network broadcasts.  Preliminary results from a recent survey of practitioners who view FDA PSN indicate that 94 percent of respondents used the program's safety recommendations "frequently" (42 percent) or "occasionally" (52 percent);
• Provide targeted risk management communication about FDA regulated products that pose adverse health risks to consumers and healthcare workers;
• Provide human factors risk analysis in premarket and postmarket cycles to enhance the identification of risks associated with the use of medical products and to reduce the occurrence of adverse events related to use error;
• Provide ongoing technical assistance to small medical device manufacturers, and provide accessible; timely feedback to industry, health professionals, and consumers.  This feedback is provided via Device Advice -- the CDRH self-service site for medical device and radiation emitting information, E-mail, Internet Comments and Feedback, links for submitting comments on proposed regulations, and use of automation to provide the public with the latest information;

• Provide consumers with current and reliable information on radiation emitting electronic products, including maintaining the Whole Body Computer Technology Scanning web site; and,
• Provide guidance to industry on the Alternative Summary Reporting program to eases industry's reporting burden for device-based adverse events.

Diabetes, Obesity and Cardiovascular Disease

The FDA actively participates in Administration and Department initiatives directed at improving the public health.  The efforts will increase the independence and quality of life of persons with disabilities and long-term care needs.  

In the area of diabetes FDA will:

• Explore whether more effective but "least burdensome" regulatory mechanisms can be put into place for to assist industry in bringing to market new devices to test, monitor, and administer medications for the management and treatment of diabetes;
• Partner with the diagnostics industry, health professionals, and diabetics to assure that diagnostics are available that are more accurate, less invasive and easier for patients to use; and,
• Maintain FDA's Diabetes Information web site, which provides consumers with information about new diabetes findings, new product approvals, upcoming panel meetings, and other current information.

In the area of obesity FDA will:

• Partner with sponsors on new, promising, investigational weight loss devices, which support the Secretary's goal to reduce the almost 300,000 U.S. deaths a year associated with obesity and overweight.

In the area of cardiovascular disease FDA will:

• Maintain FDA's Cardiovascular Information web site that is currently being developed.  The site will focus on emerging technology as well as provide information that contributes to better informed consumer participation in the prevention and treatment of cardiovascular disease.

MQSA

The MQSA program is directed to the certification of mammography facilities and to annual inspections to ensure that they remain in compliance with established quality standards. FDA will:

• Certify new mammography facilities and recertify one third of the approximately 9,200 existing facilities each year;
• Analyze and act on inspection results to ensure facility compliance with quality standards;
• Update and maintain data systems to monitor facility accreditation, certification and compliance status; and,
• Fund annual inspections for approximately 9 percent of mammography facilities deemed to be governmental entities.  The other 91 percent of the annual facility inspections are funded through user fees.

PROTECTING AMERICA FROM TERRORISM

FDA continues to monitor, evaluate, and follow up on the public health needs of new medical devices or their use in counter terrorism preparedness and response to regulate them in a manner that best serves the public health.  These activities support the Department's goals to enhance the ability of the Nations health care system to effectively respond to bioterrorism and public health challenges.  FDA will:

• Develop new diagnostic tests for field and import examinations to help investigators determine if a product has been tampered with or is otherwise tainted;
• Evaluate the safety and effectiveness of diagnostic test kits that detect biothreat agents as well as other diagnostic and therapeutic devices being developed to address such threats, that are being marketed to the public and the government;
• Predict and manage potential device shortages to ensure there are enough critical, commonly used devices, such as rubber gloves, to aid in rescue efforts, and develop mechanisms to use FDA's medical material shortage experts to assist in acquisition of limited critical medical countermeasures during a terrorist event;
• Develop field expertise to sample for contamination, high-risk products such as rubber gloves or surgical masks, and develop test methods for the Department of Defense (DOD) to test emergency devices for safe use on the battlefield and in civilian emergency care. Expand technical assistance to industry and DOD, expedite review, and expand outreach to civilian emergency medical professionals to give them more information about new devices in their field; and,
• Conduct research to advance the diagnostic technology and improve techniques for testing decontamination systems; and, assess the in vitro diagnostic market to determine the number and type of test kits that are being marketed to the public and government.  This will provide FDA with the capability to identify manufacturers that promote diagnostic devices, to monitor their activities and to act appropriately when unsafe practices are detected.

Radiological Counterterrorism and Radiation Safety

FDA continues monitoring and assessing radiation-emitting products for misuse as weapons, for safe use in detection and deterrence activities, and for the safe use and availability of new and existing radiological products.  FDA also continues preparedness activities for monitoring and assessing radiation contamination of foods and other FDA regulated products.  FDA will:

• Continue implementation of the Emergency Counterterrorism Preparedness and Response Plan for radiation;
• Assist the Transportation Security Administration (TSA), U.S. Customs, and the National Institute for Occupational Safety and Health (NIOSH) to assure worker safety during use of non-intrusive search products which emit x-rays;

• Coordinate with the Nuclear Regulatory Commission on laser safety of power plant security and all emergency preparedness exercises;
• Provide assistance to Customs and other agencies on safe use of x-ray cargo screening and electromagnetic personnel screening products;
• Increase field surveillance of x-ray security screening products subject to the FDA cabinet x-ray standard;
• Develop an electronic reporting system to reduce industry reporting time and FDA review time, and provide sufficient radiation data on security products and potential weapons to assure safety of workers and the public and to respond quickly in a terrorist event;
• Develop a mandatory standard for x-ray personnel security screening equipment based on the voluntary standard prepared by FDA, State and industry representatives;
• Develop a radiation safety consensus standard for cargo screening and other new non-intrusive search products that emit x-rays, neutrons or gamma rays; and,
• Inspect and test 10 percent of the radiological health industry. Advances in new technologies and expansion of overseas manufacturing facilities increase the likelihood that new products will not meet performance standards or standards may not exist for the new technologies.   FDA continues to detect increasing numbers of electronic product radiation emissions that far exceed radiation safety standards.

STRONG FDA

A strong FDA will ensure a world-class professional workforce, effective and efficient operations, and adequate resources to accomplish the mission of FDA.  FDA's performance goals under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) recognize that FDA needs to build infrastructure, hire and train new staff, and take other steps to lay the groundwork for success.  FDA will:

• Implement the goals accompanying the authorization of MDUFMA and set forth in the commitment letters from Secretary Thompson that addresses FDA need to build up its infrastructure to have a successful review program; 
• Train new and current staff to keep their skills current as medical device technology evolves;
• Increase access to outside experts to help improve the quality of our work; and,
• Support the President's Management Agenda and FDA's competitive sourcing A-76 effort by performing cost comparison studies for commercially identified functions.

THE MOST PUBLIC HEALTH BANG FOR OUR REGULATORY BUCK

Significant Achievements:

• Met all the MDUFMA statutory deadlines for FY 2003, and maintained or improved device review performance in areas not covered by official performance goals;
• Hired 67 new employees including scientists, engineers, project managers, statisticians, medical officers, review supervisors, and administrative staff for MDUFMA implementation. Since most of these employees were hired very late in the fiscal year, the impact on performance outputs will not be felt until FY 2004;
• Accelerated training of new and existing staff on the new guidance required to implement MDUFMA, and developed training plans to increase clinical and technical training in FY 2004;
• Expanded the use of contractors to allow FDA to meet nonrecurring review workloads, strengthen expertise, and improve the IT infrastructure;
• Developed 24 Federal Register notices and guidance documents relating to MDUFMA implementation, and published an internal "Blue Book" memo to provide guidance to FDA staff; and,
• Increased outreach efforts to stakeholders explaining the new requirements and provisions of MDUFMA. 

FDA will use science-based risk management in all Agency regulatory activities so that the Agency's limited resources can provide the most health promotion and protection at the least cost for the public.  Premarket review accomplishments include:

• Met the performance cited in the MDUFMA regulation for FY 2003, and continued to develop procedures and documents to implement new premarket review policies; 
• Initiated a Total Product Life Cycle cooperative project to determine the best way to incorporate epidemiology expertise into potential postmarket investigations and product specific postmarket plans; and,
• Improved the review process by developing a Device Evaluation Division Tracking System to increase to perform ad hoc queries and enter data, in addition to giving management a view of Division workloads to assess review performance.

Significant medical device approvals/clearances and accomplishments include:

• Cleared a diagnostic kit that sharply reduces the time needed to test patients for the West Nile Virus infection.  This test only takes hours with results available the same day, while results for the current West Nile Virus test usually take up to two weeks.  Over 7,000 human cases of West Nile Virus have already been reported to the CDC for 2003 and early treatment is important for full recovery;  
• Approved the first left ventricular assist device as a long term implant, and in patients with end stage ventricular failure who are not eligible for cardiac transplantation;
• Approved a limb salvage system for children with knee replacements that lose growth in the affected limb.  The spring expansion technology in the device eliminates or reduces the need for surgery to expand a prosthesis as the child grows; and,
• Approved a new indoor/outdoor power stair climbing wheelchair that allows greater freedom for its users since it can be used on smooth services and inclines at home and in the community, over obstacles, with uneven terrain, curbs, grass, gravel, and other soft surfaces.

Third Party Review Program accomplishments include:

• Using the third party review program for 510(k) submissions.  In FY 2003, FDA received 190 applications, a 50 percent increase over the industry's use of the program in FY 2002. This contributed to a more rapid market entry for products, since they receive marketing clearance nearly 30 percent faster than comparable 510(k)s reviewed entirely by FDA. 

Import monitoring and inspections accomplishments include:

• Exceeded the FY 2003 performance target of 20 percent coverage by inspecting 26 percent (1,428) of the registered domestic Class II and Class III medical device manufacturers;
• Met the FY 2003 performance target of inspecting 9 percent (225) of the registered foreign Class II and Class III medical device manufacturers; and,
• Conducted an Internet review to identify any manufacturers, distributors, and Internet marketers making misleading protection and prevention claims about severe acute respiratory syndrome. The review focused on infectious control devices, and FDA worked with the Federal Trade Commission to warn web site operators, manufacturers and distributors about making deceptive claims.

Inspections by accredited persons accomplishments include:

• Accredited 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 that operate in global markets an opportunity to more efficiently schedule multiple inspections. 

Human subject protection accomplishments include:

• Accomplished 364 or 123 percent, which is 69 more than the 295 target inspections planned in FY 2003; 
• Initiated an inspection program of clinical investigators, sponsors and institutional review boards to assess human subject protection measures in device clinical studies involving vulnerable or exploitable populations.  Early inspection results indicate a higher compliance rate in studies involving vulnerable or exploitable populations compared to the overall human subject protection program; 
• Halted research associated with vulnerable/exploitable populations due to unacceptable risk to patients.   Some examples of suspended research include: two silicone breast implant studies -- women with breast reconstruction issues; device study for plugging holes in babies hearts -- pediatric population; study of a vertical expandable prosthetic titanium rib -- pediatric population; study of a deep brain stimulation lead -- Parkinson patients; and a study of a stent graft device -- heart aneurysm patients; and,
• Fined an ophthalmologist and eye care center a total of $1.1 million and disqualified them from conducting further clinical studies, for 175 violations associated with a study of a laser system built to treat nearsightedness. 

Device reuse accomplishments:

• Complied with all the MDUFMA requirements relating to reprocessed single-use devices (SUDs);
• Identified and published the types of reprocessed single-use devices for which 510(k)s will be required, which triggered the MDUFMA time frame for submission of validation data for devices on the list that already are subject to a cleared 510(k);
• Published a list of critical reprocessed single-use devices whose exemption from premarket notification was revoked and requires validation data;
• Issued guidance to help manufacturers of reprocessed single-use devices understand and comply with the new premarket requirements;
• Revised the MedWatch form to reflect additional information for tracking problems associated with reused devices;
• Issued a Consent Decree of Permanent Injunction to prevent a manufacturer from shipping violative, and potentially harmful reprocessed single-use devices to hospitals; and,
• Continued to inspect hospitals that reprocess SUDs to obtain more information about the frequency of hospital reprocessing.  Based on information available to date, most hospital reprocessing has now shifted to third party sources.

Transmissible Spongiform Encephalopathy (TSE) accomplishments include:

• Participated in the interagency TSE Advisory Committee meeting that focused on decontamination of medical devices and equipment used in manufacturing, to gain more knowledge about the decontamination and inactivation of TSEs for medical devices.

International accomplishments include:

• Developed the in vitro diagnostic annex to the international standard on risk management;
• Trained and evaluated the European Union Conformance Assessment Body (CAB) auditors through the joint inspection program, and established a team to conduct on-site evaluations of United States CABs; and,
• Initiated a one-year Summary Technical Documentation pilot to assess a proposed internationally harmonized format and content for PMA and 510(k) submissions, to help determine if the harmonized format is a viable alternative to current premarket submission formats and whether the program should be continued or expanded.

Clinical Laboratory Improvement Amendments (CLIA):

Congress passed CLIA in 1988 establishing quality standards for all laboratory testing.  Published in 1992, the regulations established criteria for categorizing tests on the basis of complexity for moderate and high tests.  CLIA accomplishments include:

• Received the delegation of authority for rule making for the CLIA complexity categorization program (includes authority for waiver determinations), which previously resided with the Centers for Medicare and Medicaid Services.  The shift in authority clarifies the process for obtaining waivers for eligible diagnostic products;
• Waived the need for conventional testing under CLIA regulations for the first rapid HIV antibody test.  This test can be administered in a wide variety of outreach settings, including bars, with results available within 1 hour or less with 99.6 percent accuracy.  Waiver testing will allow many previously undetected HIV cases to be identified, resulting in earlier medical treatment and attention; and,
• Waived two respiratory virus tests for use in pediatric patients to evaluate lower respiratory tract infections, making these tests accessible for point-of-care testing in a wide variety of physician office labs, resulting in better triage of patients.

EMPOWERING CONSUMERS:  IMPROVING HEALTH THROUGH BETTER INFORMATION

CDRH communicates a broad spectrum of public health information to a wide variety of stakeholders ranging from consumers to manufacturers to healthcare providers.  This information will enable consumers to make better informed decisions by weighing the benefits and risks of FDA-regulated products.  These accomplishments include:

• Created a new web page for the Office of In Vitro Diagnostics, including information on regulatory activities, new items, and laboratory safety tips.  The web site also offers access to databases that provide information on products cleared for over-the-counter use, FDA review summaries for cleared IVDs, and recent compliance actions;
• Provided information packet to 16,000 secondary school health educators, which included a letter, the "FDA and You" web-based newsletter, and a Contacts Listing brochure.  The first issue of the newsletter (Fall 2003) contained information about toxic shock syndrome and tampons, improper use of decorative contact lenses, CDRH's bionic skeleton named "Yorick", and abdominal muscle stimulators;
• Developed and distributed a Hospital Bed Safety videotape to nursing homes and caregivers, to educate healthcare professionals about the dangers associated with patient entrapment in hospital beds.  FDA also developed a web site on this topic because since 1990, FDA has received 102 adverse event reports of head and body entrapment incidents involving hospital bed side rails, in hospitals, long-term care facilities, and private homes; and,
• Met with manufacturers of infusion pumps to educate them about the importance of human factors such as clear, simple user instructions, inform them about the FDA Human Factors program, and to provide the regulatory status of human factors.   Infusion pumps are used in home care as well as in medical facilities and remain an important area of concern to CDRH because numerous safety and use problems associated with these devices are tied directly to human factors.

IMPROVING PATIENT AND CONSUMER SAFETY

One of FDA's strategic goals is to identify risks associated with the use of medical products and reduce the occurrence of adverse events.  CDRH's adverse event data system and linkage with other heath care systems is the first line of defense against medical errors.  Patient safety accomplishments include: 

• Expanded the CDRH Medical Device Surveillance Network (MedSun) to include representative laboratories in a pilot program called "LabSun".  The goal of the pilot is to determine if this form of active surveillance can be used to supplement the current surveillance data obtained through the current Medical Device Reporting system;
• Successfully used the Medical Device Reporting system and a MedSun facility to withdraw a risky product from the market.  Because of the collaboration between the clinical community and FDA to improve patient safety, FDA became aware of key information about the product's problems.  This information led to positive discussions with the product manufacturer, resulting in the product's removal; 
• Contracted with the Institute of Medicine to initiate a postmarket surveillance study for pediatric products, focusing on various components of postmarket surveillance including:  study committee members; role of expert consultants; role of implants; pediatric safety issues; and guidance for premarket considerations; and,
• Conducted a risk/benefit assessment of alternatives to dental amalgams, so that FDA can respond to public concerns about the safety of dental amalgams.

Diabetes, obesity, and cardiovascular disease accomplishments include:

• Maintained and continued to develop the FDA disease specific web page on diabetes that combines information from all FDA Centers into one location for easy access and usability.  The web site records approximately 4,000 visits per month, and many government and consumer web sites link directly to it.  This site is now being used as a model for future disease-specific web sites at FDA;
• Cleared the first device for diabetics that integrates a glucose meter and an insulin pump with a dose calculator into one device, making it more convenient for people to manage their diabetes, resulting in fewer dosing errors;
• Cleared the first over-the-counter test that measures glycated hemoglobin to help people with diabetes monitor how well they are managing their disease.  This test, which was previously used only in medical facilities, will make it easier for many patients to monitor long-term control over their blood glucose levels, complementing the information obtained from daily finger stick blood glucose tests;
• Closely monitored insulin infusion pumps, which are being widely used by diabetics because they control blood glucose better than traditional insulin injections, and are less burdensome to the user.  There has been an increase in serious hypo and hyperglycemic events caused by faulty programmable insulin pumps.  FDA has been conducting inspections of all foreign and domestic manufacturers, leading to several recalls, a Safety Alert, numerous warning letters, and an import alert; and
• Issued a public health web notification about adverse events associated with a coronary stent.  FDA was alerted to almost 300 reports of sub-acute thrombosis through the Medical Device Reporting (MDR) system, with many associated with patient death or patient injury requiring medical or surgical intervention.

                  Coronary Stint

Science and standards accomplishments include:

• Developed and promoted the use of standards for manufacturing safer and more effective medical products and to enhance the quality of regulatory decision making.  In FY 2003, FDA recognized 25 new standards for a cumulative total of 618; and,
• Assisted in the development of a final performance testing standard for oxygen regulators through the American Society for Testing and Materials (ASTM).  This effort addressed the increasing number of reported fires and explosions that were occurring in oxygen regulators, resulting in significant burns and a death.  ASTM, NASA, FDA, and the industry all worked together to develop a test method that would identify poor designs that existing standards could not identify.

MQSA accomplishments include:

• Conducted inspections of mammography facilities and found that more than 97 percent of the facilities met the MQSA inspection standards, with only 2 percent of the facilities showing Level 1 (most serious) problems. This is the fifth consecutive year of achieving this high standard;
• Incorporated MQSA national facility inspection data on the MQSA Facility Scorecard web page.  This web page provides information about facility performance on MQSA standards, gives facilities the opportunity to compare themselves to the rest of the nation, and provides a mechanism for facilities to contact FDA regarding the scorecard and other MQSA issues; and,
• Implemented a new enforcement strategy that addresses how facilities should respond to serious (Level 1) inspection observations, and what follow-up actions FDA may take if facilities do not correct the problems. 

PROTECTING AMERICA FROM TERRORISM

FDA continues to work with other Federal, state, and local government agencies and the military to strengthen its capability to identify, prepare for, and respond to terrorist threats and incidents.   In FY 2003, FDA's Device and Radiological Health program:  Developed and implemented an Emergency Medical Device Shortage Plan that allows quick identification of device manufacturers and distributors, which gives FDA the ability to predict and manage potential device shortages.  This will help the Agency identify available inventories and locations of limited critical medical devices such as rubber gloves or ventilators, and liaison with the medical products supply chain distribution network to facilitate transport of devices;

• Participated in the government-wide TOP OFF2 exercise which tested FDA's communication capabilities and interaction with other Departments of the Federal Government and State/Local components.  FDA contributed:  radiological health expertise relating to the effects and possible contamination from the dirty bomb released in Seattle; information on the availability of respirators, gowns, gloves, masks, and other requested or anticipated medical devices; expertise to respond to inquiries regarding diagnosis and treatment products for the plague; and information for the user community on applicable devices for safety and protection;
• Updated Continuity of Operations emergency response plans, in conjunction with HHS and FDA, to identify the essential functions that need to be maintained to monitor and respond to a terrorist event or emergency situation.   The Agency also conducted emergency response training to ensure that FDA public health emergency responders were trained in emergency standard operating procedures;
• Finalized the Emergency Preparedness and Radiological Health Response plan and established a Corporate Communications Center to conduct emergency operations related to medical devices and radiological health products;
• Participated in several interagency working groups related to the use of in vitro diagnostics for the identification of biological threat agents;
• Classified preamendment laboratory diagnostic reagents for the identification of B. anthracis and Yersinia pestis as Class II devices with special controls and restricted use based on the FDA's Microbiology Devices Panel recommendation.  These devices were not included when preamendment devices classified beginning in the late 1970s;
• Evaluated the safety and effectiveness of diagnostic tests that identify biothreat agents as well as other diagnostic and therapeutic devices being developed to address such threats such as ultraviolet purifiers and sterilizers for use in decontamination of surfaces and products; and,
• Developed a Notice of Proposed Rule Making to propose an amendment to the exception from informed consent requirements (21CFR 50.23) to apply in certain circumstances involving the use of investigational in vitro diagnostic devices that identify chemical, biological, radiological, or nuclear agents. 

Radiological Counterterrorism and Radiation Safety

• Worked with government security agencies and standards organizations to develop a standard for safe security screening devices and to address safety concerns regarding the practice of exposing people to x-rays for non-medical purposes;
• Entered into a Consent Decree of Injunction with a company to prevent the manufacture and distribution of radiation therapy medical devices used for cancer treatment, that contributed to 28 patients receiving excessive amounts of radiation that led to several patient deaths;
• Partnered with state-level radiological health agencies to communicate radiological health issues directly to the end-user.  Worked closely with the National Evaluation of X-ray Trends program, and the Conference of Radiation Control Program Directors to monitor the radiation doses patients receive during diagnostic x-ray exams;
• Conducted a two-week Diagnostic X-ray Inspectors training course for state and FDA inspectors, participating in agreements with the Agency to conduct diagnostic x-ray field survey tests.  This allows the Agency to maintain an adequate number of qualified FDA and state x-ray inspectors in the field;
• Assessed civil money penalties of $475,000 against a firm manufacturing computer monitors and television receivers that continued to import products into the United States while its quality control and testing program was disapproved by FDA; and,
• Developed an electronic adverse event reporting system (eRadHealth) for radiological health manufacturers, to automate the review, analysis and management of the 19,000 radiological health safety product reports received each year.  This system provides FDA, the States, and other Federal agencies with the information necessary to make good risk management decisions, and gives health care professionals and consumers the information needed to make informed choices.

STRONG FDA

A strong FDA will ensure a world-class professional workforce, effective and efficient operations, and adequate resources to accomplish the mission of FDA.  FDA took many steps during the year to attract, develop and retain a highly skilled and diverse workforce.  Specific accomplishments include:

• Piloted a "Mentoring for Excellence Program" with five new training courses, to develop a skilled and talented pool of managers whose competencies align with the Center's strategic plan;
• Created the "Science Leadership Education Program", which is a joint educational venture between FDA, Georgetown University and Virginia Polytechnic Institute, designed to encourage continual learning;
• Developed the "CDRH Medical Device Fellowship Program" to provide an opportunity for health professionals in the scientific community to participate in the FDA medical device regulatory process, share their knowledge and experience with medical devices with FDA, and increase the range and depth of collaborations; and,
• Created the Office of In Vitro Diagnostic Device Evaluation and Safety by combining premarket and postmarket regulation of in vitro diagnostic devices into a single organization unit.  This reorganization allows internal and external stakeholders to contact one organization to get information, promotes the CDRH strategic goal of "total product life cycle", and leverages resources to create, share, and use knowledge.

Devices and Radiological Health

Program Activity Data

Field Devices and Radiological Health

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