U.S. Food and Drug Administration
Performance Plan
2002

2.5 MEDICAL DEVICES & RADIOLOGICAL HEALTH

2.5.1 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, and medical ultrasound, and x-ray machines.

FDA is faced with an increasing challenge to maintain parity with an ever-changing industry. The medical device industry has continued to grow at a rate of approximately 8 percent per year over the ten-year period ending in 1996. Since 1996, the number of firms has increased from 9,061 in FY 1997 to 13,428 in FY 2000. The medical device industry of the 21st century is developing more and more devices based on leading-edge technology. FDA has to maintain its ability to make 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; combination device-drug combination products; and pioneering organ replacement and patient assist devices.

FDA's Center for Devices and Radiological Health (CDRH) is developing a set of key strategies concentrating on ensuring the health of the public throughout the total life cycle of a product. This approach will allow the Center to focus is resources on products that are most likely to improve the effectiveness and safety of medical devices and radiological health no matter what stage of their development (concept development, active marketing, or modification). These strategies are:

1. Total Product Life Cycle (TPCL) -- develop a TPLC model in coordination with stakeholders (Internal, External, and International);
2. Knowledge Management -- manage knowledge to support TPLC (Build a knowledge culture, Exploit Information Technology, and develop CDRH as an e-Center);
3. Magnet for Excellence -- attract and retain people who want help fulfill our public health mission; and
4. Meaningful Metrics -- measure and set targets to assess our continuing impact on public health. 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 interactions with industry and other stakeholders.

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.

FY 2000 Performance Highlights

FDA has worked diligently over the past three years implementing the FDA Modernization Act (FDAMA) and reengineering initiatives that reaffirmed the device program's traditional regulatory functions and strengthened its scientific and analytical capacity for 21st century regulatory decision making. A strong science base is linked to every decision the Agency makes from providing greater patient access to new device technologies to assessing hazards and reducing medical errors. Activities conducted include the timely implementation of the FDAMA device program.

The Medical Device and Radiological Health Premarket Program is responsible for review of device marketing applications: premarket approval applications (PMAs), premarket notification 510(k)s, and investigational device exemptions (IDEs). In FY 2000, CDRH received 9,753 of these major submissions. There were no overdue submissions for the fourth consecutive year. FDA maintained high quality, timely reviews despite increasingly complex device technology.

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 inspectional coverage is decreasing and domestic recall rates are increasing. FDA did not meet its FY 2000 domestic inspection coverage goal for higher risk device firms of 22 percent. FDA's actual performance was just 18 percent, the result of an increasing number of firms to inspect and declining field resources. This is far below the statutory requirement of 50 percent. FDA is not able to routinely inspect over 7,000 lower risk firms whose products are mostly exempt from premarket review.

FDA continues to look for ways to reduce preventable deaths and injuries associated with the use of medical device products. FDA moved closer to implementing the Medical Device Surveillance Network (MeDSuN) to reduce public health risks by timely identification of actual or potential problems associated with the use of medical devices. When fully implemented, MeDSuN will reduce the occurrence of medical device related events,; serve as an advanced warning system from the clinical community; and create a two-way communciation channel between FDA and the user-facility community.

In FY 2000, FDA began Phase II of the MeDSuN pilot which will cover 25 hospital facilities. Under a collaborative agreement with the University of Maryland, FDA is developing an internet-based reporting system which will include a web site, database, and search engine.

The quality of mammography services in the United States continues to improve. In FY 2000 the goal of ensuring that mammography facilities meet inspection standards was achieved with a 97 percent rate. This was the third consecutive year of achieving this high standard. Additionally, FDA trained 16 new inspectors on the requirements of the MQSA regulations; issued 27 issues of the Mammography Matters Newsletter; performed 200 audit inspections under the Inspector Quality Assurance program; developed a continuing education video on m image scoring and distributed it to each state and district office; and calibrated testing equipment (369 sensitometers and 363 desensitometers) on a routine basis for use in the MQSA program to ensure the accuracy of measurements and inspections. FDA also drafted final regulations for "States as Certifiers" which will transfer certification authority from FDA to applicant States, as provided by MQSA. Final regulations will become effective immediately upon publication in the Federal Register sometime in April 2001.

2.5.2 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

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 premarket approval 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. Thus, FDA places all medical devices into one of three regulatory classes based on the level of control needed to assure product 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; and, Premarket Approval Applications (PMAs) - post-1976 amendments or not substantially equivalent devices. 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- 4)

FDA received a premarket funding increase in FY 2000 and FY 2001 to improve timely reviews, and for activities in the areas of reuse, genetic testing, and standards recognition. These increases are reducing review times and facilitating new technology review.

B. Summary of Performance Goals

C. Goal-By-Goal Presentation of Performance

1. Maintain the on-time percentage of Premarket Approval Application (PMA) first actions within 180 days in FY 2002. (15001)

• Context of Goal: PMAs involve potentially high-risk devices that have the highest likelihood 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.
• Data Sources: Center for Devices and Radiological Health (CDRH) Premarket Tracking System and Receipt Cohorts
• Performance: The original FY 1999 goal, as shown in the FY 1999 Congressional Justification, was revised due to better baseline data. In FY 2000, FDA performance was 96 percent for the applications received in the first six months. The performance strategy is to redirect resources from low-risk to high-risk devices. Also, reinvention efforts such as early meetings with manufacturers, modular review, streamlined reviews, and product development protocols have resulted in faster reviews. Faster reviews give patients quicker access to important new medical devices.

  This goal has been modified to remove HDEs, humanitarian use devices intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals in the U.S. per year. There are very few HDEs actually submitted to FDA, and these are normally completed within the 75-day timeframe prescribed by FDAMA.

  NOTE: PMA submissions will continue to increase in FY 2001 and FY 2002 due to technology advances, increased use of computerized and miniaturized devices. Therefore, it is expected that FY 2002 will not only be a year of more submissions but submissions will require multiple reviewers with different areas of expertise. Reviews will be more complex and take even more science time.

2. Review and complete 90 percent of Premarket Approval Application (PMA) supplement final actions within 180 days in FY 2002. (15009).

Note: workload will continue to increase in FY 2001 and FY 2002 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.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: FY 2000 performance is currently 98.7 percent for the applications received in the first six months. This goal is a new commitment in FY 2000 and FY 2001.

3. Review and complete 95 percent of 510(k) (Premarket Notification) first actions within 90 days in FY 2002. (15002)

• Context of Goal: This is an FY 1999 goal, dropped in FY 2000, and picked back up for FY 2001 and FY 2002, 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 2000 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 improve how critical resources are used. Two efforts that illustrate FDA premarket management improvements are:

  Third Party Reviews, which are consistent with FDAMA's intent to encourage access and use of outside scientific and technical expertise, provides an alternative to FDA review. In FY 1999, FDA received only 32 510(k)s with a third party review, but more than 1,200 were eligible.

  Abbreviated and Special 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 1999, the Agency received 396 Special 510(k) applications and 85 Abbreviated 510(k) submissions.

  The Agency plans to encourage more firms to use these options.

4. Review and complete 75 percent of 510(k) (Premarket Notification) final actions within 90 days in FY 2000. (15021)

• Context of Goal: This final actions goal for 510(k)s responds to stakeholder interest, especially among Congress and the device industry, in having the review completed within 90 days with no further action required
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: FY 2000 performance is currently 78 percent. This goal is a new commitment in FY 2000, and is being dropped in FY 2001, with time to first actions being determined to be a more meaningful measure of performance in this area.

5. Complete 100 percent of Investigational Device Exemption (IDE) "Agreement" meetings within 30 days in FY 2002. (15015)

• Context of Goal: This performance goal deals with FDAMA requirements for increased interactions with sponsors and covers IDE Agreement Meetings. A sponsor prior to submitting an IDE application to discuss specific investigational plans for a Class Ill or Implantable device may request an IDE Agreement Meeting. These meetings will help to expedite the review process and make medical devices available more quickly. FDA will continue to meet statutory review times and increase interactions with the medical device industry. IDEs and PMAs represent premarket approval actions that deal with devices that are complex and represent new technologies. It is intended that opening a premarket discussion with the manufacturer will greatly improve the quality of IDE and PMA submissions and result in a reduction of the review time required. Although the performance goal in FY 2002 remains at completing these meetings within 30 days, increased resources will be required to update science guidelines used at these meetings in order to keep them current with emerging medical device technologies.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: Performance was 75 percent in FY 2000. This goal is being discontinued for FY 2001.

6. Complete 100 percent of Premarket Approval Application (PMA) "Determination" meetings within 30 days in FY 2002. (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 that 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 2000 performance is 100 percent.

7. Initiate development of 20 to 25 new or enhanced standards to be used in application review in FY 2002. (15003)

• Context of Goal: Science, technology and standards activities are directed to improve science support related to the device review process. FDAMA requires FDA to recognize and use standards in the application review process. FDA plans to expand its participation in international harmonization of standards. Additionally, FDA plans to increase the use of consensus standards developed by such national and international organizations as the American Society for Testing and Materials and the International Standards Organizations to improve premarket approval times.
• Data Sources: Standard status document reports
• Performance: FDA recognized 117 standards in FY 2000 for a cumulative total of 567 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. Use of standards also helps to expedite reviews of 510(k)s.

8. Conduct 335 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.). (15025)

• Context of Goal: In FY 2002, FDA plans to initiate the BIMO program by conducting 335 investigational inspections of approximately 1000 active IDEs identified that involve vulnerable populations (e.g., pediatric). This initial effort will provide a better idea of the workload associated with a fully implemented program. Each of the IDE applications may involve 10 to15 clinical Investigators and workload information is needed.

  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. We are continuing to see an increase in these types of actions.

  In FY 2001, FDA is devoting more resources to a BIMO initiative, an area significantly impacting public health research and human subject protection. BIMO device review resources are targeted based on FDAMA requirements for timely and interactive reviews. We are seeing frequent violations of informed consent, undocumented research, and confusion of experimental and control treatments that involve millions of patients. There are an estimated 100 to 300 patients per investigator and 10,000 to 15,000 active clinical investigators in the United States.

• Data Sources: CDRH Field Data Systems
• Performance: This goal is a new commitment in FY 2002. In FY 2000, 249 BIMO inspections were conducted.

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 cover four major areas: (1) Inspections; (2) Mammography; (3) Radiation Control; and (4) Adverse Event Reporting. FDA exercises considerable discretion regarding the frequency and comprehensiveness of inspections. For approximately 4,100 high risk device establishments (excluding mammography facilities), the law requires FDA to conduct inspections at least once every two years. In addition, FDA is responsible for Low risk devices to insure that they comply with Quality System Regulations. FDA is not inspecting over 7000 Class I firms whose products are also 510(k) exempt. However, the regulations do not state a mandatory time frame for these inspections. There are also approximately 10,000 mammography facilities, which must be inspected at least once each year. The performance goals deal with establishments subject to a statutory coverage requirement.

Inspections

FDA enforces numerous regulations to protect the public from unsafe or ineffective medical devices or radiological products. FDA also informs 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 9 - 11)

Medical devices have become more medically and technologically complex and the device industry is growing domestically and internationally. This growth and a reduction in device and radiological health inspection resources have resulted in lower inspection coverage and higher violation rates. Although FDA received an increase of funding in FY 2001, the increase was offset by the need by reprogramming and the lack of an increase to cover current services. In FY 2002, FDA is requesting an appropriated funding increase for domestic inspections and additive user fees for foreign inspections and imports. FDA's inadequate device inspection coverage impairs product safety assurance and impairs FDA's ability to carry out the following responsibilities:

• FDAMA shifts premarket clearance for many low and medium risk devices to 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.
• Foreign inspection coverage is very low and 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, only 11 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 manufactures to pay for inspections by Conformity assessment bodies. Over the long term, successfully implemented MRAs will reduce the number of foreign firms requiring FDA inspection.
• Emerging device product safety assurance issues will 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.

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. (Performance Goal 12)

The MQSA requires that FDA conduct annual inspections of mammography facilities. FDA estimates that there are approximately 10,000 mammography facilities that are covered by MQSA. In some cases inspections are not completed if facilities are not certified, if there is an ongoing effort to correct problems identified during an inspection, or if facilities go out of business. The target of 9,200 inspections is based on past experience with these factors. Federal and state personnel will continue to conduct annual inspections, as well as provide training for new inspectors. The fees collected will pay for the costs of the inspections.

Radiation Safety

Radiological health resources dropped from 400 FTE in FY 1978 to about 65 FTE in FY 2000. We are seeing a resurgence of problems such as widespread new used for fluoroscopy by relatively untrained practitioners increasing the risk of over exposure. We attribute this to a lack of ability to keep up with the new developments in electronic product technology.

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 the occurrence of untoward medical device related events; serve as an advanced warning system; and create a two way communication channel between FDA and the user-facility community.

In FY 2000, FDA began Phase II of the MeDSuN pilot that will include 25 Hospitals. FDA is using FY 2001 funding to add 75 to 100 new facilities. FDA is developing an internet-based reporting system that includes a Web site, database, and search engine. This pilot will develop methodology to recruit hospitals in MeDSun by obtaining information from hospital experts on organization structure and liability concerns. (Performance Goal 13)

B. Summary of Performance Goals

C. Goal-By-Goal Presentation of Performance

9. Provide inspection coverage for Class II and Class III domestic medical device manufacturers at 20 percent in FY 2002. (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. Achievement of this goal relies on the willingness and ability of the states to contract with FDA to inspect a portion of the medical device industry. To implement these contracts, FDA's experience predicts that a significant investment in training and time is necessary to ensure quality and uniformity of inspections. The domestic workload is expected to increase by 6 percent from FY 2000 to FY 2002. Due to the workload increase, additional resources will be needed to maintain the domestic coverage rate. No class I manufacturers will be inspected. The FY 1999 goal was added in the FY 2000 Performance Plan as a result of its inclusion in the FDA Plan for Statutory Compliance, published in November 1998. Class II and Ill manufacturers are required by statute to be inspected at least once every two years. FDA is working toward meeting this statutory requirement of a 50 percent annual coverage rate.
• Data Sources: CDRH Field Data Systems
• Performance: The FY 2000 performance goal of 22 percent was not met. FY 2000 only produced a 13 percent performance rate. This failure was due to reduced field resources and increased workload.

  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 below critical mass. In addition, 510(k) exemptions for Class I products puts more need for Class I inspections to verify that firms have quality systems in place. In FY 2000, FDA inspected 13 percent of domestic manufacturers in FDA's official establishment inventory compared to 40 percent in FY 1997. Foreign manufacturer inspections also suffered dropping from 23 percent in FY 1997 to in FY 2000. None of the 3,335 Class I domestic manufacturers are being inspected

  FDAMA shifts premarket clearance for many low and medium risk devices to 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 monitor quality systems conformance at current resource levels.

  Foreign inspection coverage is very low and 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, when the MRA is successfully implemented, it will reduce the number of foreign firms that FDA will need to inspect.

  Emerging device and electronic product safety assurance issues will 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.

10. 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%) with FDA requirements. (15018)

• Context of Goal: Conformance rates estimate the post-inspection status of the establishments inspected in the given year. They are based on the number of establishments inspected, the incidence of serious deficiencies detected, and statistical data of deficiency corrections. Since firms inspected are not randomly selected from the entire population, the rates should not be applied across that population. However, as coverage of the inventory of firms is improved, the rates will better represent the overall status of the industry sector. This goal excludes mammography inspections, which are covered by goal # 12.
• Data sources: CDRH Field Data Systems
• Performance: In FY 2000, FDA had a 92 percent conformance rate.

11. Maintain inspection coverage for Class II and Class III foreign medical device manufacturers at 9 percent in FY 2002. (15005.02)

• Context of Goal: This goal includes joint inspections of high-risk device manufacturers with European Union Conformance Assessment Bodies. Foreign workload is expected to increase by approximately 7 percent. As the workload increases, coverage percentages are expected to decline. One of the major initiatives introduced to assist in reducing the inspection workload associated with medical device review is the US/European Union (EU) Mutual Recognition Agreement (MRA). In FY 1999, FDA continued to implement the MRA with the EU to help facilitate transatlantic trade and reduce costs for compliance with regulatory requirements. Activities are currently taking place to prepare third parties in the EU to perform work in the EU for FDA and to prepare third parties in the US to perform work in the US for the EU. FDA plans to proceed with MRA activities pending the availability of funds. FDA posted a web site in 1999 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. No Class I manufacturers will be inspected.
• Data Sources: CDRH Field Data Systems
• Performance: In FY 2000, FDA inspected

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 below critical mass. In addition, 510(k) exemptions for Class I products increases the need for Class I inspections to verify that firms have quality systems in place. Foreign manufacturer inspections suffered, dropping from 23 percent in FY 1997 to 11 percent in FY 2000.

FDAMA shifts premarket clearance for many low and medium risk devices to 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 monitor quality systems conformance at current resource levels.

Foreign inspection coverage is very low and 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, when the MRA is successfully implemented, it will reduce the number of foreign firms that FDA will need to inspect.

Emerging device and electronic product safety assurance issues will 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.

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.
• Data Sources: Mammography Program Reporting and Information System (MPRIS)
• Performance: The FY 2000 goal of ensuring that mammography facilities meet inspection standards was achieved with a 97 percent rate. 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. 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 did 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 website, collaboration with NIH to provide a list of MQSA-certified facilities, a consumer brochure, meetings with consumer groups, and interactive teleconferencing for facilities.

13. Enhance the MeDSuN System by implementing Drugs and Biologics training in recruited hospitals. (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. 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. In FY 2002, FDA will continue to recruit new facilities for the MeDSun program. FDA estimates that there may be as many as 300,000 injuries and deaths annually associated with device use. FDA will use additional FY2001 resources to maintain the facilities in the program, expand the program by recruiting 75-100 new user facilities, and extend the program to other types of facilities such as ambulatory care surgical centers. FDA will begin implementing MeDSuN, and 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. 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: This goal is a new commitment in FY 2000 and FY 2001.

14. Meet timeframes of Reuse Regulatory Strategy (new in FY 2002)

• Context of goal: The increase in the reuse medical device market and the increase of eldercare devices for an increasing number of older Americans has brought been to the Agencies attention. The number of problems is on the increase and with the growing patient universe is becoming a major concern of FDA. Therefore, FDA intends to develop legislation to further protect the pubic from contamination or possible disease.
• Data Sources: FDA Legislative Tracking System
• Performance: This goal is a new commitment in FY 2001.

2.5.3 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, 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 systems newest component is the MedSun program. MeDSun, the Medical Device Surveillance Network, is an initiative designed both to educate all health professionals about the critical importance of being aware of, monitoring for, and reporting adverse events and 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.

The purpose of the MedSun program is to enhance the effectiveness of postmarketing surveillance of medical products as they are used in clinical practice and to rapidly identify significant health hazards associated with these products.

The program has four goals:

1. To increase awareness of drug and device-induced adverse events.
2. To clarify what should (and should not) be reported to the Agency.
3. To make it easier to report by operating a single system for health professionals to report adverse events and product problems to the Agency.
4. To provide regular feedback to the health care community about safety issues involving medical products

The MeDSuN program is supported by over 140 organizations, representing health professionals and industry, that have signed on as MedWatch Partners to help achieve these goals.

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.

Previous | Table of Contents | Next