2.5 MEDICAL DEVICES AND RADIOLOGICAL HEALTH

2.5.1 Program Description, Context, and Summary of Performance

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.

The FDA Modernization Act of 1997 (FDAMA) requires FDA to conduct more timely and interactive application reviews, improve the quality and timeliness of postmarket surveillance data, expand participation in international harmonization activities, and improve information and education for industry and health professionals. In order to implement these mandates, FDA will identify and concentrate resources on high-risk, high-impact products or work areas, those where its direct intervention helps consumers and health care professionals the most. FDA will build its device science base to maintain and update the organizational capability to make timely regulatory decisions.

Growth in the size of the medical device industry and in the complexity of new medical devices will continue to challenge FDA to stay up to date with breakthrough medical devices and to maintain high quality timely reviews, required interactions with industry, and current review guidance. Research and development expenditures by the industry increased 91% from 1990 to 1996 with an increase of approximately one billion dollars projected from 1997 to the year 2000. Quantum leaps in device miniaturization, microprocessor software control, artificial intelligence decision support, remote operation, and drug/biologics tissue combinations are already revolutionizing medical care.

The pace of technology innovation in this country and around the world requires the Center's cadre of scientists to keep up with the latest technology and scientific advances, in both the development of medical technology and scientific methodologies. Only by doing so can personnel provide high quality, timely and science based regulatory actions on the safety and effectiveness of new medical products and the causes of inferior performance including public health impact. FDA intends to emphasize the need to maintain high quality scientific decision making. This is especially critical for emerging technologies like 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.

These challenges are represented by two key strategic goals for the 21st Century:

• Provide quicker access to important, life-saving and health-enhancing medical devices, while assuring their 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 Agency's approach to achieving these strategic goals, as well as key performance goals that will move the Program in these directions, are outlined in the strategic goal sections.

FY 99 Program Accomplishments

FDA has worked diligently over the past two years on 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 99, CDRH received 9,792 submissions There were no overdue submissions for the third consecutive year. FDA maintained high quality, timely reviews despite increasingly complex device technology. Approximately 800 device applications now in house depend on new or advanced technology. FDA completed a collaborative effort with FDA stakeholders to identify tools and principles to be used in considering the "least burdensome" means that will allow appropriate premarket development and review of a product without unnecessary delays and expense to manufacturers.

FDA exceeded its FY 99 domestic inspection coverage goal of 26 percent with a performance of 30 percent. However, this is still below the statutory requirement of 50 percent, the result of an increasing number of firms to inspect and declining field inspection resources. 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. Implementation of FDAMA requirements, ongoing reengineering, and FDA's commitment to a strong science base have resulted in an examination of how FDA conduct inspections. FDA is working with the medical device industry to reengineer the process used for Quality System inspections. The new technique significantly reduces the inspection time and increases the effectiveness of the inspections.

The quality of mammography services in the United States continues to improve. FY 99, FDA mammography activities included conducting approximately 9,500 facility inspections and issuing 5,499 three-year facility certificates. Additionally, FDA performed 170 audit inspections under the Inspector Quality Assurance Program and hosted a MQSA Satellite Teleconference in February 1999 that provided an interactive platform for over 2,000 viewers to get answers to questions about regulatory requirements.

2.5.2 Strategic Goals

Approach

Medical Devices intended for marketing in the United States are subject to rigorous premarket review by the FDA. Prior to marketing a device, manufacturers must seek FDA safety and effectiveness approval of their products. FDA is responsible for assigning marketed medical devices to a regulatory category. Medical devices vary widely in their complexity and their degree of risk or benefits. They 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 necessary to assure safety and effectiveness of the device. These classes are:

      Class I -General Controls
      Class II - General Controls and Special Controls
      Class III - General Controls, Special Controls and Premarket Approval

Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples of Class I devices include elastic bandages, examination gloves, and handheld surgical instruments.

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.

Class III is the most stringent regulatory category for devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

FDA reviews: 1) Premarket Notifications (510(k)s -- products substantially equivalent to products on the market; 2) Investigational Device Exemptions (IDEs) -- devices used in clinical investigations on human subjects; and 3) Premarket Approval Applications (PMAs) -- devices that support or sustain human life, which present a reasonable risk of illness or injury. To accomplish this premarket responsibility, FDA is charged with review of submissions within the time frames specified in the law. FDA strives to support a stable and predictable review process, and meet statutory FDAMA requirements for reduced review times for PMAs and 510(k)s and increased interactions with sponsors. FDA is also striving to reduce review time for PMA supplemental applications. Performance Goals 1 through 4 set targets for PMAs, PMA supplements, and 510(k)s.

Research and Standard-Setting Contributions to Premarket Review

FDA's goal is to provide science-based device product safety assurance to the public. Resources are being utilized to increase participation of science expertise in the review and approval of high-risk medical devices during premarket review. In addition, efforts are underway to develop and promote consensus performance standards as guides of safer and more effective medical products and to enhance the quality of regulatory decision making.

FDA would identify in guidance documents those standards that may address aspects of a substantial equivalence determination, such as specified testing. Manufacturers would certify that their devices met the standards, and submit that certification to the Agency in lieu of the underlying data. Manufacturers would retain the option of taking alternative approaches and submitting the underlying data to FDA. In most cases a given standard would address only some aspects of a substantial equivalence determination for a particular device, but there may be instances where a standard or combination of standards would address all aspects of a 510(k) decision. Performance Goal 7 sets targets for standards.

With this increase, FDA will be able to remain current in all scientifically relevant areas, keep abreast of emerging technologies, and translate the knowledge into standards that will expedite getting safe, beneficial medical device products to the public. Areas of possible research include:

Supporting Standards Development

• Develop comprehensive methods and performance requirements for critical device standards to optimize the amount of information manufacturers have to provide in premarket submissions.

Products and Health Safeguards for Critical Patient Groups

• Facilitate the use of products for use by diabetics.
• Develop and test new technologies for the detection and management of changes in mechanical competence of bone.

Reducing Costs of Clinical and Pre-Clinical Trials

• Develop and validate statistical and quantitative methods for reducing costs of clinical studies without compromising scientific validity.

Possible new research projects include:

• Reuse of devices;
• Medical image acquisition and display systems;
• New sensor technologies planned for integration into medical devices;
• Artificial implanted organs and devices that can complement and extend the capabilities of organs whose functions can be partially salvaged.
• Medical devices that are less invasive than open surgery.

Leveraging/Communication

FDA will be able to improve its ability to receive and distribute device-related scientific information into, around, and out of the organization in an efficient manner. Current plans include:

• Developing a scientific exchange program to share information, cross-train staff, and improve communication and support among Agency programs. This approach leverages the resources currently available with academic institutions, the States, and field and headquarters offices to provide developmental opportunities for selected scientific staff.
• Developing a FDAMA communications strategy to improve the dialogue between FDA and its stakeholders. This strategy will allow FDA to provide timely and unbiased information to the public, including approval requirement information to industry.
• Encouraging dissemination of information and scientific exchange through the use of standardized computer systems, integrated technologies, and enhanced web sites on the internet/intranet. These improvements will allow for greater information sharing between FDA and its stakeholders and among the FDA centers.

FDA is moving towards regulatory requirements that are consistent from nation to nation, which benefits both FDA and industry. Toward that end, FDA is recognizing an increasing number of international standards as a way to satisfy part of our 510(k) requirements. FDA has signed a Mutual Recognition Agreement with the European Union and has assumed chairmanship of the Global International Harmonization Task Force.

Reinvention

FDA has been reinventing many medical device premarket processes to use resources more effectively and efficiently. Many of these efforts were already under way before FDAMA. FDAMA accelerated many of these efforts and added others. Reinvention efforts include:

Early Meetings with Manufacturers -- Early meetings benefit both FDA and the manufacturer. FDAMA specifies early collaboration, and FDA is taking this even further. Performance Goals 5 and 6 set targets for early meetings with manufacturers.

Modular Review -- This involves breaking PMAs down into bite-size chunks, which customizes the submission and gives the manufacturer timely feedback.

Streamlined Review -- FDA is pilot testing streamlined review for well-understood PMA products.

Product Development Protocols (PDPs) -- Used in lieu of PMAs, PDPs are advance agreements that clearly identify requirements up front, benefiting both FDA and the firm.

Changing the 510(k) Paradigm -- FDA is making the process more efficient by exempting well-understood, low-risk products; making it easier to notify FDA about changes; encouraging use of FDA recognized consensus standards; and using third party reviews. This saves FDA resources and allows more time for high-impact devices.

Other Improvements in the Review Process- FDA is improving manufacturer access to advisory panels.

C. Goal-By-Goal Presentation of Performance

1. Increase the on-time percentage of Premarket Approval Application (PMA) first actions (within 180 days) and HDE first actions (within 75 days) completed to 90% in FY 01. (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. An HDE is submitted for a humanitarian use device that is 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. FDAMA established a requirement that FDA review HDEs within 75 days. An HDE is similar in both form and content to a PMA, but is exempt from the effectiveness requirements of a PMA.
• Data Sources: Center for Devices and Radiological Health (CDRH) Premarket Tracking System and Receipt Cohorts
• Performance: The original FY 99 goal, as shown in the FY 99 Congressional Justification, was revised due to better baseline data and a funding change. So far the FY 99 goal is on schedule with a 67% performance as of 12/31/99. Final data will not be available until May 2000. The performance strategy is to redirect resources from low risk to high risk devices. Also, reinvention efforts like early meetings with manufacturers, modular review, streamlined reviews, and product development protocols have resulted in faster reviews. Faster reviews will give patients quicker access to the important new medical devices they need.

HDEs provide an easier approval path for devices used to treat rare conditions or diseases. In FY 99, FDA approved six HDEs, including two septal occlusion devices for closing holes between the left and right sides of the heart, a sacral nerve stimulator to aid in urination and bowel evacuation in spinal cord injured patients, and a pulmonary valve for children under age 4 with absent or diseased valves.

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

• 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 the addition of a new indication. It is essential that FDA complete the review process for these products quickly and thoroughly. This was a new goal for FY 00.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: This goal is a new commitment in FY 00 and FY 01.

3. Review and complete 95% of 510(k) (Premarket Notification) first actions within 90 days in FY 01.(15002)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY 01. This goal for first actions on 510(k)s within 90 days addresses the statutory requirement to review a 510(k) within 90 days. The original FY 99 goal, as shown in the FY 99 Congressional Justification, was revised due to better baseline data.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: So far the FY 99 goal is on schedule with a 99.7% performance as of 12/31/99. Final data will not be available until February 2000. FDA has been completing nearly 100% of first actions on time. 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, is using more consensus standards in its reviews, and is using more third party reviews. As a result, these 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. To date, FDA has recognized 13 third party bodies and made 154 types (mostly Class IIs) of devices eligible for third party review. In FY 99, FDA received only 32 510(k)s with a third party review, but more than 1,200 were eligible.

Abbreviated and Special 510(k) Submissionsprovide 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 99, 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% of 510(k) (Premarket Notification) final actions within 90 days in FY 01. (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. A final action could be the first and only action required prior to marketing or it could be an additional action to complete the review after a first action resulted in the need for additional information from the firm.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: This goal is a new commitment in FY 00 and FY 01.

5. Complete 100% of Investigational Device Exemption (IDE) "Agreement" meetings within 30 days. (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 III 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 pre-market approval actions that deal with devices that are complex and represent new technologies. It is intended that opening a pre-market discussion with the manufacturer will greatly improve the quality of IDE and PMA submissions and result in a reduction of the review time required. This was a new goal for FY 00.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: This goal is a new commitment in FY 00 and FY 01.

6. Complete 95% of Pre-market Approval Application (PMA) "Determination" meetings within 30 days.

• 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 pre-market approval meetings will reduce the pre-market review times and result in moving new products to the market faster. This was a new goal for FY 00.
• Data Sources: CDRH Premarket Tracking System and Receipt Cohorts
• Performance: This goal is a new commitment in FY 00 and FY 01.

7. Participate in the development of 20 to 25 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. 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. The original FY 99 goal, as shown in the FY 99 Congressional Justification, was revised due to better baseline data.
• Data Sources: Standard status document reports
• Performance:FDA recognized 450 standards in FY 99. 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.

Strategic Goal 2:

Approach

Medical device risk reduction activities cover four major areas: (1) Inspections; (2) Mammography; (3) Radiation Control: (4) Adverse Event Reporting. FDA exercises considerable discretion regarding the frequency and comprehensiveness of inspections. For approximately 4,100 device establishments (excluding mammography facilities), the law requires FDA to conduct inspections at least once every two years. There are 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 with FDA's GMP Act; 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 8, 9, and 10 deal with inspections.

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 rates. 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 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 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 during the 1990's as many as 1.8 million women will be diagnosed with breast cancer, and 500,000 will die from it. The probability of survival increases significantly, however, when the disease is detected in its early stages. 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 sets the quality target for mammography facilities.

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 8,900 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

Manufacturers of radiation-emitting products such as x-ray machines, lasers, microwave heating equipment, television and ultrasonic therapy equipment are required to submit initial reports, annual reports, and model change reports to FDA. In conjunction with its regulatory efforts, FDA carries on specialized programs to reduce patient exposure during diagnostic x-ray procedures by encouraging improved practice among health professionals and by developing new x-ray techniques. FDA makes continual checks to assure that the potential of radiation can be realized at a minimum risk of harm. As new radiation-producing electronic products are developed, FDA evaluates them to ensure they are safe. Performance Goal 11 deals with radiation safety.

Adverse Event Reporting

A key element in any comprehensive program to regulate medical devices is postmarket reporting a 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. Performance Goals 13 and 14 deal with a MedSun System for collecting data on adverse events and summary reporting to enhance protection of the public health.

Research and Standard-Setting Contributions

FDA needs to update regulatory science to keep up with increasingly complex, high-tech medical device products. FDA will also be able to conduct forensic research in the field to support criminal investigations of medical devices. Areas of possible research include:

• Develop and evaluate techniques to reduce unnecessary exposures to radiation from electronic products and disease-causing organisms.
• Develop methods for monitoring and controlling microbial resistant biofilms on medical devices.

As technology progresses, the scope of radiation-emitting products increases much faster than the knowledge of bioeffects. Adverse event reports, recalls, and noncompliance rates are monitored for adjustments in priorities. Personnel of multiple disciplines and specialized training, along with specialized test equipment, are utilized to assess bioeffects and safety, to enforce performance standards, to develop proposals for new standards, both regulatory and consensus, and to present recommendations to an advisory committee prior to publication of Federal Register notices. Interpretive policies are developed to permit greater flexibility in meeting requirements that are not critical to radiation safety.

Leveraging/Communication

Achievement of FDA's domestic inspection coverage 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.

FDA will maintain inspection coverage of a growing number of Class II and Class III foreign device firms by working more closely with foreign regulatory bodies and conducting inspections most needed to develop joint inspection standards thus improving the safety of future U.S. device imports. This includes joint inspections of high-risk device manufacturers with European Union Conformance Assessment Bodies. Foreign workload is expected to increase by approximately 20 to 25%. Due to the workload increase, additional resources are necessary to maintain the present coverage rate for all firms. No class I manufacturers will be inspected

In the area of Bioresearch Monitoring, recent feedback from Institutional Review Boards (IRBs) has shown that many need a better understanding of the differences between drug and medical device clinical trials. To respond to this need, FDA has increased outreach to IRBs. We've encouraged them to access our web page, and we've increased our participation in IRB seminars and workshops.

Reinvention

FDA is pursuing a number of reinvention efforts in the postmarket area. These include:

Summary Reports -- We're saving FDA and industry resources by eliminating individual adverse event reports where such events are well known and clearly defined. We're now using summaries for 12 device types, and we're ready to expand the list.

Design Controls -- Our Quality System regulation will strengthen design controls for devices. We just completed a transition and education period, showing that most firms are using design controls, but some need improvement.

Changes in the Inspection Process -- FDA is pilot-testing several new approaches: a new system for warning letters that will consider a firm's written response to the inspection report and make special provision for 510(k) and labeling violations; new guidance on when to inspect for changes in PMA'd devices; a new model to prioritize inspections based on risk; a new approach, the Quality System Inspection Technique (QSIT) system, to evaluate quality systems; and the "HACCP" concept to focus on specific safety parameters.

The purpose of the QSIT reengineering effort is to develop an inspection program covering the quality systems regulation, which results in more focused and efficient inspections. The effort should help FDA investigators focus in on key manufacturing and quality areas at the manufacturer during inspections, in order to determine their state of compliance with the Quality Systems Regulation. FDA believes that this effort will lead to increased compliance with the Quality Systems Regulation, and thus improved medical device product quality. Improved medical device product quality could result in fewer problems with medical devices. In addition, fewer enforcement actions may be needed for Quality Systems Regulation violations, and better public health should result. Since several aspects of this program have been derived from the Global Harmonization Task Force's document entitled Guidelines for Regulatory auditing of Quality Systems of Medical Device Manufacturers, a third benefit is harmonization.

C. Goal-By-Goal Presentation of Performance

8. Improve inspection coverage for Class II and Class III domestic medical device manufacturers to 28%. (15005.01)

• Context of Goal: This goal includes inspections done by FDA directly, or through state contracts or partnership agreements on Class II and III 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 full benefit of additional contract inspections will not be realized until FY 2002 since part of FY 2001 will be devoted to contract set up. Also, domestic workload is expected to increase by almost 20% from FY 1999 to FY 2001. Due to the workload increase, additional resources will be needed to both maintain and increase the coverage rate. No class I manufacturers will be inspected. The FY 99 goal was added in the FY 00 Performance Plan as a result of its inclusion in the FDA Plan for Statutory Compliance, published in November 1998. Class II and III 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% annual coverage rate.
• Data Sources: CDRH Field Data Systems
• Performance: The FY 99 goal of 26% was met with a performance of 30% in spite of reduced field resources and an increased workload. However, inspection coverage has declined each year since FY 97 and is expected to continue to decline in FY 00 because of an increasing number of firms and reduced field inspection resources. Implementation of FDAMA requirements, ongoing reengineering, and FDA's commitment to a strong science base have resulted in an examination of how FDA conducts inspections. FDA plans changes which will improve the statutory inspection coverage rate beginning in FY 01.

FDA has worked with the medical device industry to reengineer the process used for Quality System inspections. The new technique will significantly reduce the inspection time and increase the effectiveness of the inspections. This will be an essential tool as the device program faces declining resources and a growing industry. FDA implemented the Warning Letter Pilot Test. The pilot allows firms 15 days to respond to and/or correct problems identified during an inspection. FDA does not issue warning letters if the problems are adequately corrected. FDA believes that this is beneficial in getting firms to correct problems quickly. FDA plans to make inspections more useful to manufacturers and consumers.

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%) 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. The original FY 99 goal, as shown in the FY 99 Congressional Justification, was revised due to reduced funding.
• Data sources: CDRH Field Data Systems
• Performance: FDA exceeded the FY 99 goal of 90% with a performance of 95%. Conformance rates for FY 97, FY 98, and FY 99 have been adjusted to reflect the observed average correction rate for each year.

10. Maintain inspection coverage for Class II and Class III foreign medical device manufacturers. (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 20 to 25%. One of the major initiatives introduced to assist in reducing the inspection workload associated with medical device review is the U.S./European Union (EU) Mutual Recognition Agreement (MRA). In FY 99, FDA continued to implement the MRA with the EU which will 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 U.S. and EU Conformity Assessment Bodies (CABs) that are participating in confidence building activities. The site is: http://www.fda.gov/cdrh/mra/index.html

No class I manufacturers will be inspected. This was a new goal for FY 00.

• Data Sources: CDRH Field Data Systems
• Performance: This goal is a new commitment in FY 00 and FY 01.

11. Maintain response to significant electronic product risk by initiating regulatory actions and recalls for 95% of identified high risk, non-compliant or defective products within 30 days of discovery. (15008)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY 01. Under the Radiation Control for Health and Safety Act (RCHSA), FDA conducts an electronic radiation control program to assess the biological effects resulting from all types of radiation exposure, evaluates radiation emissions from electronic products, conducts research to minimize exposure, and sets and enforces radiation performance standards. The original FY 99 goal, as shown in the FY 99 Congressional Justification, was revised due to minor editorial changes.
• Data Sources: CDRH Tracking Data, FDA and state laboratory guides, recall files and Inspection reports.
• Performance: FDA met the FY 99 goal of 95% for the 4th consecutive year. Because of this consistent performance, this goal is being dropped from the performance plan.

12. Ensure that at least 97% of mammography facilities meet inspection standards, with less than 3% of facilities with Level 1 (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. The original FY 99 goal, as shown in the FY 99 Congressional Justification, was revised due to minor editorial changes.
• Data Sources: Mammography Program Reporting and Information System (MPRIS)
• Performance: The FY 99 goal of ensuring that mammography facilities meet inspection standards was achieved with a 97% 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% 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. Recruit over 200 more hospitals into a MedSun System that uses improved data format and collection methods to enhance the validity and reliability of data provided, thus affording a higher level of public health protection. (15012)

• Context of Goal: FDAMA authorizes FDA to discontinue universal user facility reporting and implement a MeDSuN surveillance system composed of a network of user facilities that constitute a representative profile of user reports. The user surveillance system currently under development 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. The Medical Device Surveillance Network (MeDSuN) is FDA's response to FDAMA's provision that universal user reporting can be replaced with a system that is limited to a subset of user facilities that constitutes a representative profile of user reports. FDA has successfully completed a pilot. FDA will evaluate the pilot and report to Congress and plans to proceed if funds are available.
• Data Sources: CDRH Adverse Events Reports
• Performance: This goal is a new commitment in FY 00 and FY 01.

14. Increase the number of low-risk postmarket reports received and processed in summary form. The total number of summary reports will be increased from 20,000 in FY 98 to over 25,000 in FY 99. (15004)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY 01. FDA is responsible for monitoring the market for injuries related to medical devices. The major efforts in the postmarket area are focused on the improvement of our ability to detect and analyze medical device problems by focusing on high-risk devices and expanding scientific efforts. Summary reporting of lower risk reports streamlines reporting requirements and allows priority to be placed on high-risk reports. FDA received over 63,000 postmarket reports plus 20,000 summary reports in FY 98. The original FY 99 goal, as shown in the FY 99 Congressional Justification, was revised due to reduced funding.
• Data Source: CDRH Adverse Events Reports
• Performance: The FY 99 goal was accomplished by using innovative surveillance methods and improving quality and analysis needed for Safety Alerts and other actions. In FY 99, FDA took steps to further reduce the reporting burden by enhancing the current system with the new Alternative Summary Reporting (ASR) system that will allow summary data elements to be submitted in line-item format. Approximately 38,000 summary reports were received in FY 99. Forty-five manufacturers are now participating in the summary reporting program and 52 individual product classification codes are included in the program.

In 1996, a medical device reporting (MDR) network was established in the Los Angeles District as a cooperative venture with the medical device community, regulatory consultants, and the Orange County Regulatory Affairs Association to exchange information on FDA requirements. FDA was invited to participate. The group received the Vice President's Hammer Award in 1999.

15. Improve quality conformance of high-risk products like cardiovascular devices by committing over 75% of inspection resources to high-risk devices. (15016)

• Context of Goal: This is the FY 99 goal. It is included here only for FY 99 reporting. There is no similar goal in FY 00 or FY 01. Goal was discontinued in FY 01 and dropped in FY 00 due to a change of emphasis among goals. The original FY 99 goal, as shown in the FY 99 Congressional Justification, was revised to measure specific resource investment.
• Data sources: CDRH Field Data Systems
• Performance: The FY 99 goal of 75% was not met. Approximately 50 % of resources were committed to high risk devices due to competing priorities within the Agency. This goal will not be continued because it is a basic activity goal that does not focus on results or outcomes.

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.

Adverse event reporting -- FDA's adverse event reporting systems are dependent upon the MedWatch program. MedWatch, the FDA Medical Products Reporting Program, 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 MedWatch 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 disease
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 MEDWATCH 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.

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