U.S. Food and Drug Administration
Performance Plan
2002

2.6 MEDICAL DEVICES & RADIOLOGICAL HEALTH

2.6.1 Program Description, Context and Summary of Performance

Total Program Resources:

FDA's Medical Devices and Radiological Health Program is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to manmade radiation from medical, occupational, and consumer products. There are thousands of types of medical devices, from heart pacemakers to contact lenses. Radiation-emitting products regulated by FDA include microwave ovens, video display terminals, medical ultrasound equipment, and x-ray machines. In addition, FDA is taking on new priorities to support the Administration's fight against terrorism. For the Device and Radiological Health program, Counter-terrorism activities include expedited review of bioterrorism diagnostics, managing product shortages, supporting the safe and effective development and use of battlefield and emergency devices, working to ensure safe use of people scanners in airport and other security systems, and increased monitoring of imports.

FDA is faced with an increasing challenge to maintain parity with an ever-changing, rapidly growing industry. The number of device firms domestically and internationally has increased from 9,061 in FY 1997 to 13,701 in FY 2001 and projected to increase to over 15,000 in FY 2003. The medical device industry of the 21st century is developing more and more devices based on leading-edge technology. FDA is responsible for regulating 10,000 mammography facilities under the MQSA and over 4,000 radiological health firms under RCHSA. The device program is also responsible for oversight of 15,000 active clinical investigators. FDA has to maintain its regulatory mission by making high quality scientific decisions. This is especially critical for areas of emerging technologies such as: computer-related technology; molecular medicine; home-care and self-care devices; minimally invasive technology; device-drug combination products; and pioneering organ replacement and patient assist devices. FDA's premarket functions support the Department's Prevention Priorities, and the postmarket functions support the Department's Medical Errors/Healthcare Quality Priorities. In addition, many devices are used by the elderly and directly relate to the Department's priorities for patient diagnostic care. CDRH also regulates diabetes diagnostics.

FDA's Center for Devices and Radiological Health (CDRH) has developed key strategies to more directly promote and protect the public health through the total life cycle of a product. This will allow CDRH to focus regulatory resources on products in a least burdensome way no matter what their stage of development; from concept development to active marketing or modification.

• Total Product Life Cycle (TPLC) -- Apply TPLC model in coordination with stakeholders;
• Magnet for Excellence -- Attract and retain a diverse workforce to accomplish our public health mission;
• Meaningful Metrics -- Measure and communicate our impact on the public health; and
• Knowledge Management -- Manage knowledge to support TPLC in the information age.

FDA has updated review guidance and procedures to ensure safe and effective products reach the market quickly. FDA intends to leverage its own efforts by working closely with stakeholders to maximize the quality and timeliness of regulatory decisions and information exchange. To meet these challenges, two key strategic goals have been established for the 21st Century:

• Provide the medical community with faster access to important, life-saving and health-enhancing medical devices, while assuring safety and effectiveness.
• Reduce the risk of medical devices and radiation-emitting products on the market by assuring product quality and correcting problems associated with their production and use.

The Center is working toward improving areas that are not working well in the following scorecard by using the elements of the Strategic Plan:

Program Area	Working Well	Working But Facing Challenges	Not Working Well
Device Review
Regulatory Science
Device Inspection
Device Post-Market Surveillance
Mammography
Radiation Safety

2.6.2 Strategic Goals

Strategic Goal 1:
Provide the medical community with faster access to important, life-saving and health-enhancing medical devices, while assuring their safety and effectiveness.

A. Strategic Goal Explanation

In the FY 2003 budget, FDA requests cost of living increases that will be needed to meet FY 2003 device review performance targets. FDA is also proposing to use part of its Counter-terrorism funding to expedite review of diagnostics to detect bioterrorism agents like anthrax in humans. Due to competing priorities, FDA is not requesting any other program increases to improve device review in the FY 2003 budget. FDA also requested cost of living increases in FY 2002, which will be needed to meet FY 2002 device review performance targets.

Medical Devices marketed in the United States are subject to rigorous premarket review by FDA. Prior to marketing a device, manufacturers must seek FDA clearance or safety and effectiveness approval of their products using FDA's device review processes. Medical devices vary widely in their complexity and their degree of risk or benefits, and do not all need the same degree of regulation. Under the FDCA places all medical devices into one of three regulatory classes based on the level of control needed to provide reasonable assurance safety and effectiveness.

FDA reviews: Premarket Notifications (510(k)s -- products substantially equivalent to products on the market; Investigational Device Exemptions (IDEs) -- devices used in clinical investigations on human subjects that are considered safe and effective; and, device types (no "s") developed after the 1976 Device Amendments for which safety and effectiveness data must be submitted by the sponsor to the FDA for review. FDA is charged with review of submissions within the time frames specified by law. FDA strives to support a stable and predictable review process, meet statutory requirements for review times for PMAs and 510(k)s, and increase sponsor interaction. (Performance Goals 1-5)

In measuring device review performance, CDRH follows Agency standards in measuring and reporting review time, defining statutory review time requirements, and setting performance goals. FDA's device review performance goals follow the Agency standards of using receipt cohorts to measure the percentage of FDA reviews completed within the number of days specified by the statute, for the "cohort" of applications received in a particular year. Some device-specific review time definitions follow to help stakeholders interpret device review data.

For 510(k)s, section 510(k) of the Federal Food, Drug and Cosmetic Act establishes a 90-day timeframe for the review of a premarket notification. In addition, 21 CFR 807.81(a) and 21 CFR 807.87(1) reference the 90-day benchmark for 510(k)s. If a final decision on the notification cannot be made on the basis of the information supplied by the manufacturer, it is placed on hold and a new 90-day review (cycle) begins when the requested information is received.

For premarket approval applications (PMAs), section 515(d)(1)(A) of the Federal Food, Drug and Cosmetic Act establishes a 180-day review benchmark for Agency action on a PMA. In addition, 21 CFR 814.37(c)(1) and 21 CFR 814.40 reference a 180-day review period (cycle) for a PMA. A new 180-day review period begins when a major amendment (containing significant new or updated data, detailed new analyses, or information previously omitted) is received. FDA works collaboratively with manufacturers to make the total review time less than 180 days.

The total review time for rendering a decision (either approval or disapproval, clearance or not substantially equivalent decisions) on a premarket application includes both FDA time and non-FDA time. The FDA time includes the number of days FDA took to review the application that led to a final approval decision. The non-FDA time is the time spent by the manufacturer responding to FDA's requests for information.

FDA cannot control the amount of time a manufacturer takes to respond back to FDA's concerns about deficient applications (other than deleting the applications after a certain amount of hold time has elapsed). FDA continues to work with industry to make applications more complete and scientifically sound when they are submitted to FDA. FDA's goal is to streamline the internal review process and improve the quality of premarket submissions received from manufacturers so the total review time is within FDAMA statutory requirements.

B. Summary of Performance Goal

C. Goal-By-Goal Presentation of Performance

1. Review and Complete 95 percent of Premarket Approval Application (PMA) first actions within 180 days. (15001)

• Context of Goal: PMAs involve potentially high-risk devices with most chance of significantly improving the treatment of patients. It is essential that FDA complete the review process for these products quickly and thoroughly. The statutory requirement is to review PMAs within 180 days. Workload is expected to increase in FY 2003.
• Data Sources: Center for Devices and Radiological Health (CDRH) Premarket Tracking System and Receipt Cohorts
• Performance: In FY 2001, FDA performance was 97 percent for the applications received in FY 2001. The performance strategy is to redirect resources from low-risk to high-risk devices. Reengineering of the PMA process to include early meetings with manufacturers, modular review, streamlined reviews, and product development protocols have speeded reviews. Faster reviews give patients quicker access to important new medical devices.

2. Review and complete 95 percent of Premarket Approval Application (PMA) supplement final actions within 180 days. (15009).

Note: workload will continue to increase in FY 2003 due to increased submissions and advances in technology.

• Context of Goal: PMA supplements involve potentially high-risk devices that have the highest likelihood of significantly improving the treatment of patients. Supplemental applications are generally submitted for changes in already approved products such as technology changes or the addition of a new indication. It is essential that FDA complete the review process for these products quickly and thoroughly.
  Real-time PMA Supplement review is a regulatory tool that gives sponsors the option of participating in "real-time" reviews that are conducted by teleconference or face-to-face. This gives manufacturers a chance to discuss all of FDA's review issues at one time. Last year, sponsors of over 25 percent of the 545 PMA supplements submitted to FDA chose real-time reviews, mostly by teleconference.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: FY 2001 performance was 98.4 percent for the applications received in FY 2001.

3. Review and complete 95 percent of 510(k) (Premarket Notification) first actions within 90 days. (15002)

• Context of Goal: This is an FY 1999 goal, dropped in FY 2000, and picked back up for FY 2001, FY2002, and FY 2003, as a more meaningful measure of performance in this area. This goal for first actions on 510(k)s within 90 days addresses the statutory requirement to review a 510(k) within 90 days.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: FY 2001, performance is 100 percent. This performance has resulted from FDA changing the way 510(k)s are reviewed. FDA is exempting more low-risk products from the 510(k) requirement, using more consensus standards in its reviews, and using more third party reviews. As a result, devices are available more quickly to patients and resources savings are available for high-impact devices. FDA is working to optimize how critical FDA and industry resources are used. The two efforts below illustrate FDA device review improvements. FDA encourages firms to use these regulatory options.

Third Party 510(k) Reviews are consistent with FDAMA's intent to encourage use of outside scientific and technical expertise, and provide an alternative to FDA review. During FY 2001, FDA received 107 510(k)s reviewed by third parties.

• a. 510(k)s reviewed by Accredited Persons received FDA marketing clearance 29 percent faster than comparable 510(k)'s reviewed entirely by FDA. An added bonus is that most Accredited Persons have specialized expertise in areas that may be helpful to 510(k) submitters, such as device testing, standards, or foreign regulatory requirements. In an effort to encourage greater use of the Third Party Program, FDA implemented an expansion pilot in 2001 that allowed Accredited Persons to review many Class II devices that were not previously eligible. The pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. FDA's website is at http://www.fda.gov/cdrh/thirdparty/.
• b. Special and Abbreviated 510(k) Submissions provide manufacturers with reengineered submission procedures established by CDRH's New 510(k) Paradigm. These submissions are simpler to process than traditional 510(k)s, allowing more rapid market clearance. In FY 2001, As of September 30TH the Agency has received 717 Special 510(k) applications and 174 Abbreviated (510(k). 685 Special 510(k)s were processed within 32 days and all of the Abbreviated 510(k)s were acted on within the required 90 days, FDA expects to receive an estimated 1000 Special and Abbreviated 510(k) submissions in 2002.

4. Expedite review for 100 percent of Bioterrorism Diagnostic Medical Device Applications. (15028)

• Context of Goal: This performance goal deals with a new area for FY 2003 (Bioterrorism). FDA will review diagnostic test devices and test kits that detect or measure bioterrorism agents like anthrax in humans that are being marketed within the U.S. Currently there are no approved commercial diagnostics for this purpose, and FDA is working with industry on applications. The review work on diagnostics started in FY 2002, and is a new performance goal for FY 2003.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts.
• Performance: This is a new goal for FY 2003 and therefore, has no performance history.

5. Complete 100 percent of Premarket Approval Application (PMA) "Determination" meetings within 30 days. (15024)

• Context of Goal: This performance goal deals with FDAMA requirements for increased interactions with sponsors and covers PMA Determination Meetings. A PMA Determination Meeting may be requested by a prospective PMA applicant to determine the type of scientific evidence necessary for PMA approval. FDA will continue to work to meet statutory review times and increase interactions with the medical device industry. FDA anticipates the use of premarket approval meetings will reduce the premarket review times and result in moving new products to the market faster.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: FY 2001, performance was 100 percent.

6. Recognize 20 new or enhanced standards to be used in application review. (15003)

• Context of Goal: Science, technology and standards activities are directed to improve science support related to the device review process. FDA works on other standards expected to benefit the entire medical device industry to improve premarket approval times. Use of standards also helps to expedite reviews of 510(k)s and in certain cases to fill a standard void. As example: No standardized protocol for the cleaning of devices after use but prior to sterilization is available. FDA requested the Association for the Advancement of Medical Instrumentation (AAMI) to initiate standards development in that area. The AAMI Sterilization Standards Committee has initiated the development of such a protocol. When completed, this protocol will be useful to hospitals and others who clean medical devices prior to their being placed back into service.
• Data Sources: Standard status document reports
• Performance: FDA recognized 30 standards in FY 2001 and 117 standards in FY 2000 for a cumulative total of 597 at the end of the year. FDA works closely with standards organizations like the American National Standards Institute (ANSI) and the International Standards Organizations (ISO) to improve its use of consensus standards. FDA is also promoting the use of consensus performance standards as guides in the design of safer and more effective medical products and to enhance the quality of regulatory decision making.

7. Conduct 290 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.). (15025)

• Context of Goal: In FY 2003, FDA plans to conduct 290 BIMO Inspections, the same number as in FY 2002. CDRH has approximately 1000 active Investigational Device Exemptions (IDEs) of high-risk investigational devices (e.g., implantable cardiac defibrillators, artificial skin, digital mammography diagnostic units). Approximately 10 percent of these cover studies involving vulnerable populations. CDRH is continuing to see an increase in these types of actions.
• Data Sources: CDRH Field Data Systems
• Performance: This goal is a new reporting commitment in FY 2002. In FY 2001, 238 BIMO inspections were conducted. FDA did not achieve it's performance goal of 250 device bioresearch inspections because the absence of a cost of living increase reduced the number of Field staff available to do device bioresearch inspections.

Strategic Goal 2:
Reduce the risk of medical devices and radiation-emitting products on the market by assuring product quality and correcting problems associated with their production and use.

A. Strategic Goal Explanation

Medical device risk reduction activities include: (1) Device Inspections; (2) Mammography Program (3) Radiation Safety; and (4) Adverse Event Reporting. In addition, FDA is setting new performance goals for Counter-terrorism, including implementing an emergency preparedness and response plan for radiation contamination incidents, and beginning to develop radiation safety standards for expanded use of people scanners in airports and other security systems.

FDA estimates the number of domestic and international device firms will grown to over 15,000 in FY 2003. For approximately 5,500 domestic higher risk device establishments and over 3,000 foreign higher risk device firms (excluding mammography facilities), the law requires FDA to conduct inspections at least once every two years. FDA is also responsible for regulating over 7,000 lower risk devices to insure they comply with Quality System Regulations. FDA does not routinely inspecting about 4,000 domestic and 3,000 foreign Class I firms. Most of their Class I products are also 510(k) exempt. However, the regulations do not establish a mandatory time frame for lower risk inspections. There are also approximately 10,000 mammography facilities, which must be inspected at least once each year. FDA is also responsible for regulating about 4,350 radiological health firms domestically and internationally. FDA is responsible for regulating these firms but the law does not specify how frequently inspections or product testing should be done. The inspection performance goals for devices, MQSA and radiological health focus on statutory coverage requirements.

Device Inspections

FDA enforces numerous regulations to protect the public from unsafe or ineffective medical devices or radiological products. FDA also confirms and verifies that medical device firms are knowledgeable and utilize Good Manufacturing Practices (GMP). Inspections of devices fall into three categories: 1) Routine Surveillance Inspections-to determine compliance; 2) Targeted Inspections-for approval to market high risk devices; inspections triggered by adverse reaction incidents; or product recalls; 3) Compliance Inspections-to collect evidence for pending enforcement actions. (Performance Goals 7 - 10)

Medical devices and electronic products are increasingly complex, and industry is growing domestically and internationally. This growth and reduced inspection resources have reduced inspection coverage with the result that when manufacturers are inspected, they have increased violation rates. In FY 2002, FDA requested an appropriated funding increase for domestic inspections and additive user fees for foreign inspections and imports, but these increases will not enable FDA to meet statutory inspection requirements. FDA's inadequate device inspection coverage impairs product safety and FDA's ability to meet the following responsibilities:

FDAMA reduces reliance on premarket clearance for many low and medium risk devices favor postmarket quality systems conformance. Firms may declare conformity to standards or quality systems requirements as part of streamlining premarket clearance. However, FDA can not monitor adherence to standards or quality systems conformance at current resource levels.

Domestic higher risk inspection coverage was only 20 percent in FY 2001 compared to the statutory requirement of 50 percent, and violation rates were high.

Foreign higher risk inspection coverage was only 11 percent in FY 2001 equal to the 11 percent rate in FY 2000. Additionally, the mutual recognition agreement implementation with the EU will require extensive training of EU assessment bodies by FDA. FDA cannot maintain foreign inspections or successfully implement the MRA with current resources. To date, less than 25 percent of the several hundred foreign manufacturers contacted have agreed to participate in the MRA Inspection Program. Foreign manufacturers will not participate in the program unless they believe that FDA inspections are likely to occur. Sufficient funding is needed to assure an inspection level adequate to motivate foreign firms to pay for inspections by Conformity Assessment Bodies. Over the long term, successfully implemented MRAs will reduce the number of foreign firms FDA needs to inspect but until the MRA is fully implemented it is unlikely that devices will satisfactory have an inspection presence with foreign firms.

Emerging device product safety assurance issues require increased attention. These include enforcing new standards for patient leads and cables, home health care, medical software, latex products and allergic reactions, interventional fluoroscopy, digital imaging, electronic article surveillance, new laser technology, and electronic magnetic interference.

Radiation Safety

Radiological health resources dropped from 400 FTEs in FY 1978 to less than 50 FTEs in FY 2001. We are seeing a resurgence of problems in both the medical and consumer product area. For examples, FDA issued a public health notification to emphasize the importance of radiation doses during CT procedures. The Agency is extremely concerned because the overexposure of children or small adults during computed tomography (CT) procedures can easily go unrecognized since medical personnel can not simply tell that a patient has been over exposed. FDA also monitored cases of unnecessary radiation emitted during fluoroscopy. Principal risks to patients from over-exposure include long term possibilities for cancer induction and a short term potential for skin burns. FDA is proposing new regulations that it estimates would save lives from over-exposure by requiring more restrictive specifications for new equipment. FDA has also partnered with the American College of Cardiology to address user issues through education.

FDA's radiological health program is challenged with working with all the new technology that is currently available and on the horizon, and solving problems that were solved years ago but are coming back with a new twist. Radiation-induced skin burns are an example of a resurgence of an old radiation issue. Reports in the MDR database and the medical literature shows that these injuries result from the use of fluoroscopy in conjunction with interventional procedures. FDA is also dealing with the expanding overseas facilities, which contribute roughly 335 million foreign made products.

FDA is concerned that projected coverage falls to low to ensure FDA can effectively regulate radiation safety. FDA will do what it can with available resources to address the expanding problems being reported. (Performance Goal 9).

Mammography

Breast cancer is the most commonly diagnosed non-skin cancer and the second leading cause of cancer deaths among American women. Experts estimate that one of every eight American women will contract breast cancer during their lifetime. When the disease is detected in its early stages, the probability of survival increases significantly. Currently, the most effective technique for early detection of breast cancer is screening mammography, an x-ray procedure that can detect small breast tumors and abnormalities up to two years before they can be detected by touch. The Mammography Quality Standards Act (MQSA) was signed into law on October 27, 1992, to address the health need for safe and reliable mammography. Final regulations for "States as Certifiers", which will transfer certification authority from FDA to applicant States, were published in the Federal Register. In FY 2001, FDA ensured that 97 percent of mammography facilities met inspection standards, with 3.4 percent with Level 1 (serious) problems. The slight increase above the GPRA goal of 3 percent for this element was likely due to the fact that under the final regulations, which became effective in April 1999, several citations were elevated to Level I. (Performance Goal 11).

Adverse Event Reporting

A key element in any comprehensive program to regulate medical devices is a postmarket reporting system through which FDA receives reports of serious adverse events. Such reporting forms the basis for corrective actions by the Agency, which include warnings to users and product recalls. This is especially true as FDA moves towards less direct involvement in the premarket review of lower-risk devices. The Medical Device Surveillance Network (MeDSuN) System when fully implemented will reduce device-related medical errors; serve as an advanced warning system; and create a two way communication channel between FDA and the user-facility community. MeDSuN is also FDA's pilot for establishing a network of user facilities that will require user reporting for only a subset of facilities. During FY 2001, FDA began feasibility testing with 25 hospitals and worked on software changes needed for website health data security. In FY 2002, FDA is adjusting the performance goal downward from 125 facilities to 80 facilities. Concerns and problems with development timing, unanticipated program changes, and increased information technology security requirements. FDA projects recruiting up to 80 facilities by the end of FY 2002, and, depending on funding, up to 125 facilities by the end of FY 2003. (Performance Goal 12)

B. Summary of Performance Goals

C. Goal-By-Goal Presentation of Performance

8. Provide inspection coverage for Class II and Class III domestic medical device manufacturers at 20 percent. (15005.01)

• Context of Goal: This goal includes inspections done by FDA directly, or through state contracts or partnership agreements on Class II and Ill domestic medical device manufacturers. Class II and Ill manufacturers are required by statute to be inspected at least once every two years. Reuse inspections have been incorporated into the domestic higher risk inventory, which is projected to increase from 5,000 to 5,500 in FY 2003. FDA plans to conduct 200 reuse hospital inspections in FY 2003, and these will need to be conducted with base resources. In FY 2002, inspections of hospitals reprocessing class I devices will be educational in nature. Formal GMP inspections will be reserved for those hospitals reprocessing higher risk class II and III devices. The approximately 4,000 class I lower risk domestic firms will not be inspected on a routine basis: only "for cause" to follow up on problems identified in recalls or reported by the public. During FY 2002, FDA plans to use base resources to inspect a sample of Class I firms to monitor Quality Systems conformance.
• Data Sources: CDRH Field Data Systems
• Performance: In FY 2001, FDA exceeded its FY 2001 performance target (17 percent) by inspecting 20 percent of 4,900 domestic higher risk Class II and Class III manufacturers. FDA's statutory performance requirement is 50 percent. With the exception of those inspected for cause, many manufacturers of low risk Class I devices have never been inspected. To develop a better understanding of their compliance rate a small number of such firms were inspected.
  Medical devices comprise a wide array of products that have become medically and technologically more complex. While the medical device industry is growing and revolutionizing, FDA's inspection coverage is not keeping pace with the new device firms, and domestic recall rates are increasing. Medical devices and radiological health inspection resources have been reduced by 23 percent since FY 1995 and these resource limitations have put coverage below critical mass.
  FDAMA exempts many lower risk devices from pre-market approval, and relies instead on postmarket quality systems conformance. Firms may declare conformity to standards or quality systems requirements as part of streamlining premarket clearance. However, FDA will be unable to routinely monitor quality systems conformance for lower risk at current resource levels. In FY 2002, FDA plans to inspect a sample of these firms.

9. Assure that FDA inspections of domestic medical device manufacturing establishments, in conjunction with the timely correction of serious deficiencies identified in these inspections, result in a high rate of conformance (at least 90 percent) with FDA requirements. (15018)

• Context of Goal: (Goal Dropped for FY 2002 and 2003) In previous FDA performance plans, goals were established for maintaining the level of industry conformance to FDA requirements at 90 percent or above for each of the Agency product-oriented programs. This year we are recommending that these goals be deleted from the Plan. This is our rationale: Inspections are the Agency's method for determining whether an establishment is in or out of compliance with FDA requirements. The Agency must allocate a significant proportion of its inspections to high risk situations, such as firms who are producing high risk medical devices, or where the technology is rapidly evolving and must be more closely monitored. The number of remaining inspections each year is not adequate to draw a statistically valid inference about the compliance status of an entire industry at a reasonably high level of confidence.
  It is also the Agency's judgement that the majority of firms in the regulated industries are in conformance with FDA's requirements. Based on the Agency's experience over several years, that percentage in general, has remained at 90 percent or above. Thus, establishing a performance goal that simply describes the stable state of the industry does not provide useful new information; nor does it serve as a management tool to drive the overall industry to a higher level of conformance.
• Data sources: CDRH Field Data Systems.
• Performance: In FY 2000, FDA had a 92 percent conformance rate. In FY 2001, FDA had a 96 percent conformance rate.

10. Provide inspection coverage and product testing coverage of the Radiological Health industry.

• Context of Goal: Radiological health resources have continued to drop from 400 FTEs in FY 1978 to less than 50 FTEs in FY 2001. FDA is seeing a resurgence of problems in both the medical and consumer radiological product area such as widespread new uses for fluoroscopy by relatively untrained practitioners increasing the risk of over exposure and high emission rates from consumer products. We attribute this to a lack of coverage of industry shipments and the fact that FDA is not able to keep up with the new developments in electronic product technology. FDA has monitored cases of unnecessary radiation emitted during fluoroscopy. Principal risks to patients from over-exposure include long term possibilities for cancer induction and a short term potential for skin burns. FDA is proposing new regulations that would require more restrictive specifications for new equipment. FDA estimates the new regulations can spare 723 lives per year from radiation-induced cancer, recognizing it averages 30 years for the long-term radiation-induced cancer to emerge after exposure. FDA has also established a working collaborative with the ACC, (cardiologists being a most frequent user to educate other users.)
  FDA also receives approximately 5000 electronic product reports yearly. Since FDA can't review these on a one-by-one basis, FDA plans to select product areas which require immediate attention by testing specific automatic screening criteria for electronic reports.
• Data sources: CDRH Rad Health Data Systems. FDA estimates there is almost no overlap between the device inspection coverage goals and this radiological health coverage goals because the device inspections and radiological health inspections examine different things and require different inspector training. FDA works in partnership with the states.
• Performance: In FY 2001, FDA estimates there were approximately 4,350 active radiological health firms FDA is responsible for regulating domestically and internationally. In FY 2001, FDA was only able to provide coverage for about 10 percent of these firms. To conserve resources, FDA initiated activities to prioritize and leverage its radiation protection efforts with state governments, professional societies, and other federal agencies. Additionally, in FY 2001, FDA initiated a working group to develop an electronic reporting system for laser products, which account for three-quarters of the reports submitted on radiation-emitting electronic products.

11. Provide inspection coverage for Class II and Class III foreign medical device manufacturers at 9 percent in FY 2003. (15005.02)

• Context of Goal: The foreign higher risk Class II and III inventory is expected to increase from 2,550 in FY 2002 to 3,000 in FY 2003. As workload increases, inspection coverage is expected to be only 9 percent in FY 2002 and 9 percent in FY 2003. The approximately 3,000 Class I lower risk foreign manufacturers will not be routinely inspected, only for cause. This goal includes joint inspections of high-risk device manufacturers with European Union Conformance Assessment Bodies. The mutual recognition agreement implementation with the EU will require extensive training of EU assessment bodies by FDA. FDA cannot maintain foreign inspections or successfully implement the MRA with current resources. In the long term, if the MRA is successfully implemented, it could reduce the number of foreign firms that FDA will need to inspect. FDA supports a web site dedicated to MRA activities, including the implementation plan, eligible device lists, MRA meeting minutes, and the list of nominated US and EU Conformity Assessment Bodies (CABs) that are participating in confidence building activities. The web site is: http://www.fda.gov/cdrh/mra/index.html.
• Data Sources: CDRH Field Data Systems
• Performance: In FY 2001, FDA foreign inspection rate was 11 percent and 266 inspections were conducted compared to 261 inspections conducted in FY 2000. Although medical devices and electronic products have become more medically and technologically complex and the industry is growing domestically and internationally, device and radiological health inspection resources have been reduced by 23 percent since FY 1995. The compliance program is focused on the improvement of enforcement actions by redirecting current resources to high-risk devices such as implants. However, limitations on inspection resources have put coverage far below critical mass. FDA cannot maintain foreign inspections or successfully implement the MRA with current resources.

12. Ensure that at least 97 percent of mammography facilities meet inspection standards, with less than 3 percent of facilities with Level I (serious) inspection problems. (15007)

• Context of Goal: This goal will ensure that mammography facilities remain in compliance with established quality standards and to improve the quality of mammography in the United States. In the Mammography Quality Standards Reauthorization Act (MQRSA) of October 1998, Congress authorized the FDA to undertake a demonstration program to assess the results of conducting mammography inspections less frequently than annually for the highest performing facilities. The program implementation date is May 2002. The MQSA is also up for reauthorization this year.
  Under MQSA, trained inspectors with FDA, with State agencies under contract to the FDA, and with States that are certifying agencies, performed annual MQSA inspections. State inspectors do approximately 94 percent of inspections. Inspectors performed science-based inspections to determine the radiation dose, to assess image quality, and to empirically evaluate the quality of the facility's film processing. MQSA requires FDA to collect fees from facilities to cover the cost of their annual facility inspections. FDA also employed an extensive outreach program to inform mammography facilities and the public about MQSA requirements. These included a quarterly newsletter for facilities, an internet web site, collaboration with NIH to provide a list of MQSA-certified facilities, a consumer brochure, meetings with consumer groups, and interactive teleconferencing for facilities.
• Data Sources: Mammography Program Reporting and Information System (MPRIS)
• Performance: During FY 2001, FDA ensured that 97 percent of mammography facilities met inspection standards, with 3.4 percent with Level 1 (serious) problems. The slight increase above the GPRA goal of 3 percent for this element was likely due to the fact that under the final regulations, which became effective in April, 1999, several citations were elevated to Level I, and some new Level I citations were added. Additionally, FDA Performed 169 audit inspections under the Inspector Quality Assurance program and trained 26 new inspectors on the requirements of the MQSA regulations.
  This was the third consecutive year of achieving this high standard. Inspection data continue to show facilities' compliance with the national standards and in the quality of x-ray images. Improving the quality of images should lead to more accurate interpretation by physicians and, therefore, to improved early detection of breast cancer. FDA worked cooperatively with the states to achieve this goal.

13. Build the MeDSuN System by Expanding the Network to 180 Facilities. (15012)

• Context of Goal: FDAMA gives FDA the option to replace universal user facility reporting with the Medical Device Surveillance Network (MeDSuN) surveillance system composed of a network of user facilities that constitute a representative profile of user reports. FDA estimates that there may be as many as 300,000 injuries and deaths annually associated with device use and misuse. MeDSuN will give FDA the health information it needs to identify and address some of those problems. MeDSuN is based on the premise that a select group of highly trained reporting facilities can provide high quality, informative reports that can be representative of user facility device problems in general. MeDSuN is FDA's response to FDAMA's provision that universal user facility reporting be replaced with a system that is limited to a subset of user facilities that constitutes a representative profile of user reports. FDA is adjusting the performance goal downward from 125 facilities to 80 facilities. The reason for this is that in FY 2001, FDA delayed implementing feasibility testing due to extended software development and unanticipated program changes and increased information technology security requirements. FDA began feasibility studies with only 25 facilities instead of the 75 facilities originally projected for FY 2001. FDA expects to add more facilities to the network throughout FY 2002. FDA projects recruiting up to 80 facilities by the end of FY 2002, and, depending on funding, up to 180 facilities by the end of FY 2003. When fully implemented, the system will enhance our ability to promote and protect the health and safety of patients, users, and others who use our products and to reduce mandatory reporting requirements for most user facilities. MeDSuN will allow FDA to determine the extent of problems associated with medical device products and to develop appropriate mechanisms for providing feedback to the health care community and the public. The long-term goal of MeDSuN is to expand the system to drug and biological products.
• Data Sources: CDRH Adverse Events Reports.
• Performance: In FY 2001, FDA did not meet the goal of recruiting 75 hospitals because most of the effort was focused on extended software development for the Internet-based reporting system (interactive web-based form and database), unanticipated program changes and increased information technology security requirements. FDA did recruit 25 hospital facilities. Throughout FY 2002, FDA will add more facilities, and projects recruiting a total of 80 facilities for the network. The long-term goal is to expand the program to include different types of health care facilities and to include drug and biologic products.

14. Implement Emergency Counter Terrorism Preparedness and Response Plan for radiation.

• Context of Goal: CDRH is updating an emergency response plan used in the past to respond to radiation contamination incidents like Three Mile Island. With part of its Counter-terrorism funds, CDRH will update the radiation emergency response plan to include counter terrorism events. In FY 2003, CDRH will implement as much of the plan as resources will allow. CDRH's radiological health resources for emergency preparedness have been severely reduced in past years, and the requested increase for Counter-terrorism funds will not be enough to fully staff the radiation emergency response teams.
• Data Sources: CDRH's radiation emergency preparedness response plan.
• Performance: This is a new goal for FY 2003 and therefore, has no performance history.

15. Begin to develop radiation standards for the safety of novel or new technology used to scan people in airports and other places.

• Context of Goal: In response to recent terrorist attacks, the increase of scanners in airports and other security systems has increased exponentially. But the increased use of security scanners also increases risks of radiation exposure. The health effects of expanded use of people scanners haven't been adequately tested, and standards need to be set for their safe use. FDA is responsible for working with FAA and industry and other standard setting stakeholders to set radiation safety standards. FDA will work to update standards within a portion of its requested Counter-terrorism resources. FDA does not have enough resources to aggressively conduct extensive testing in this area, and must work with the other stakeholders.
• Data Sources: CDRH standard setting documents.
• Performance: This is a new goal for FY 2003 and therefore, has no performance history.

2.6.3 Verification and Validation

Premarket -- To help ensure Agency consistency in tracking and reporting premarket activities, the Medical Device Program utilizes the Premarket Tracking System, which contains various types of data taken directly from the premarket submissions. FDA employs certain conventions for monitoring and reporting performance; among these are groupings of premarket submissions into decision and receipt cohorts. Decision cohorts are groupings of submissions upon which a decision was made within a specified time frame, while receipt cohorts are groupings of submissions that were received within a specified time frame. The premarket performance goals are based on receipt cohorts. Final data for receipt cohorts are usually not available at the end of the submission year. Because the review of an application received on the last day of the submission year, e.g., a PMA with 180 day time frame, may not be completed for at least 6 months or longer, final data for the submission or goal year may not be available for up to a year after the end of the goal year.

Mammography -- The Mammography Program Reporting and Information System (MPRIS) is a set of applications used to support all aspects of the FDA implementation of the Mammography Quality Standards Act of 1992. This includes the collection, processing and maintenance of data on mammography facility accreditation and certification, FDA inspections and compliance actions. MPRIS is envisioned as a centralized repository of information that supports FDA's mission to improve the quality of mammography and improves the overall quality, reliability, integrity, and accessibility of facility certification, inspection, and compliance data by eliminating multiple versions of the data while expanding and automating data edits, validation, and security of a single integrated database.

User Facility Adverse Event Reporting -- FDA's adverse event reporting system's newest component is the Medical Device Surveillance Network, MedSuN program. MeDSuN is an initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events, medical errors and other problems to FDA and/or the manufacturer and; to ensure that new safety information is rapidly communicated to the medical community thereby improving patient care.

CDRH Field Data Systems -- Data systems include the Program Oriented Data System (PODS) and the Field Accomplishments Tracking System (FACTS). PODS tracks field activities conducted by FDA's field force and the firms over which FDA has legal responsibility. PODS provides most of the information on inspections and other field activities. Field personnel have the major responsibility for assuring the quality of PODS data. CDRH also has its own systems to supplement these Agency systems.

Other Data Sources -- These include miscellaneous reports, guides, and files as cited in the data sources for several of the goals.

Contact Information:
Planning Staff, Office of Planning, FDA
Phone: 301-827-5210

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