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2.6.1 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, 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, Counterterrorism 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 regulate an ever-changing, rapidly growing industry. The number of domestic and international device firms has increased from 9,061 in FY 1997 to 13,701 in FY 2001 and projected to increase to well over 15,000 in FY 2004. The medical device industry of the 21st century is developing increasing numbers of more complex devices based on 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. All three of the preceding factors add to projected increases in device review times. FDA is also responsible for regulating 10,000 mammography facilities under the MQSA and over 4,000 radiological health firms under RCHSA plus the responsibly for oversight of 15,000 active clinical investigators. FDA uses risk management to maximize the impact of our limited resources. FDA's premarket functions support the Department's Prevention initiative, and the postmarket functions support the Department's initiative Re-aligning the Possibilities of 21st Century Health Care. Many devices used by the elderly directly relate to the Department's priorities for patient diagnostic care. CDRH regulates diabetes diagnostics.

CDRH has established two program goals to accomplish its mission for the future.

1. To promote the public health by assuring devices are safe and effective before they go to market.
2. To protect the public health by keeping marketed products safe.

To achieve its mission, CDRH has developed four key strategies to more effectively promote and protect the public health in a dynamic 21st Century environment:

• Total Product Life Cycle (TPLC) -- Efficiently focus regulatory resources, in the least burdensome way, through the total life cycle of a product - from concept development to active marketing or modification. Apply TPLC with stakeholders
• Magnet for Excellence -- Attract and retain a diverse workforce to serve the public health;
• Meaningful Metrics -- Measure and communicate our impact on the public health;
• Knowledge Management - Bring the right knowledge at the right time to relevant decisions.

The scorecard below illustrates several areas within the Medical Device and Radiological Health Program that are not working as well as they should because of major infrastructure gaps in areas such as training, international harmonization, and information systems. The Center is working toward improving performance in these areas by implementing its strategies.

2.6.2 Strategic Goals

Strategic Goal 1:
To promote the public health by assuring devices are safe and effective before they go to market.

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 device review processes. Medical devices vary widely in complexity and their degree of risk or benefits, and do not all need the same degree of regulation. The FD&C Act places all medical devices into one of three regulatory classes based on the level of control needed to provide reasonable assurance of safety and effectiveness. Definitions of device applications are at the end of this section.

The FY 2004 President Budget requests a $5 million investment in device review: $1 million in appropriated funds to sustain device review performance and $4 million in new user fees to significantly improve device review performance. This funding package would provide significant improvements in review performance of about 25 percent to 50 percent in most areas over the next few years. FDA needs this investment to promote the public health by keeping marketed products safe. Resource increases will enable the Agency to maintain high levels of performance in light of environmental factors such as the following:

• Recent Improvements In Device Review Time Have Mortgaged The Future: Recent improvements in review time have been achieved by diverting significant resources from other FDA programs, and comprehensive reengineering of device review. These tools can't achieve similar future results. CDRH is operating legacy systems to scan and track applications, and lacks the IT infrastructure to move toward electronic reviews.
• FDA's Ability to Accommodate Increasingly Complex Workloads is Diminished FDA is challenged in meeting its statutory review requirements because device technology is increasingly complex, but its science infrastructure needed to keep reviewers current has eroded. Approximately 25 percent of PMA applications are for breakthrough technologies that present novel questions and issues that go beyond the current experience and training of FDA review staff. In addition, more than 25 percent of PMAs come from mostly small, first time submitters, with extra needs for outreach and interaction. In addition, FDA reviewers require ongoing training to enhance their capabilities to judge these new, complex technologies.

The table below summarizes key performance goals for FY 2004. These goals are derived from the Secretary's Letter to Congress ("Goals Letter") that accompanies the Medical Device User Fee and Modernization Act of 2002.

Performance goals in the Goals Letter take two forms: cycle goals and decision goals. Cycle goals identify the number of days for FDA to take an action on an application within any one cycle. For example, "First action - major deficiency letter to issue within 150 days" is a cycle goal. Decision goals identify the number of days for FDA to perform a complete review and issue a decision letter. Decision letters include: approval, approvable, approvable pending GMP inspection, not approvable and denial. Decision goals are more stringent than cycle goals because only the issuance of a letter reflecting complete review decision is counted as a success; the issuance of interim letters, such as major deficiency letters (for PMAs) or additional information letters (for 510(k)s), do not count as a success.

Neither of these goals are final action goals. Final action goals would count the time it takes FDA to reach an approval or a denial decision. These types of goals are not appropriate and have not been incorporated in this Performance Plan. FDA review time is largely dependent on the quality of the incoming submission, both with respect to the quality of the data provided and in ability of that data to support reasonable safety and effectiveness of the product. For those applications currently received that are of poor quality, CDRH attempts to work with applicants, often over multiple review cycles, to obtain the needed information such that safe and effective products can be brought to market. If final action goals were put in place, this type of interaction, which usually benefits smaller companies and first-time submitters, would be greatly reduced, resulting in a greater number of denials. Further, the goals presented in the Goals Letter are those that were discussed and agreed to by FDA and industry representatives in the development of MDUFMA. To alter those goals would be an abrogation of that agreement.

Although the goals below are derived from the Goals Letter associated with MDUFMA, baseline data for these categories will not be available until late in FY 2003 or in some cases, FY 2004. As our tracking systems are refined to capture data in these selected categories, the table will be populated with current performance data. It is important to note that each of these categories represents a challenge to the Center (between 10 and 25 percent improvement) based on best estimates of current performance.

FDA Performance Goals Derived From the Medical Device User Fee and Modernization Act of 2002

Premarket report
a report submitted under section 515(c)(2).

Panel-Track Supplement
a supplement to an approved premarket application or premarket report under section 515 that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness.

180-day Supplement
a supplement to an approved premarket application or premarket report under section 515 that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling.

²For PMAs and PMA supplements: "FDA decision" also includes withdrawal, conversion and other final administrative actions not resulting in approval or denial. For 510(k)s, "FDA decision" also includes final administrative actions that do not result in a substantially equivalent/not substantially equivalent decision, because the application was withdrawn, deleted due to lack of response, a duplicate, a transitional device, not regulated by CDRH, a general purpose article, exempted by regulation or other miscellaneous action.

B.   Summary of Performance Goals

Performance Goals	Targets	Actual Performance	Reference
1. Complete Review and Action on 90% of Premarket Approval Application of an estimated 80 (PMA) first actions within 180 days. /1 (15001)	FY 04: 90% FY 03: 90% FY 02: 90% FY 01: 90% FY 00: 85% FY 99: 65%	FY 04: FY 03: FY 02: 97% of 33 FY 01: 97% of 70 FY 00: 96% of 67 FY 99: 74% of 43	3
2. Complete Review and Action on 95% of an estimated 725 PMA supplement final actions within 180 days. /1 (15009)	FY 04: 95% FY 03: 95% FY 02: 90% FY 01 90% FY 00: 85%	FY 04: FY 03: FY 02: 95% of 498 FY 01: 98.4% of 641 FY 00: 98.7% of 545	3
3. Complete Review and Action on 95% of an estimated 4,500 510(k) (Premarket Notification) first actions within 90 days. /1 (15002)	FY 04: 95% FY 03: 95% FY 02: 95% FY 01: 95% FY 00: NA	FY 04: FY 03: FY 02: 100% of 4322 FY 01: 100% of 4248 FY 00: 100% of 4202	3
4. Expedite review for 100% of an estimated 5 Bioterrorism Diagnostic Medical Device Applications. (15028)	FY 04: 100% FY 03: 100% FY 02: NA FY 01: NA	FY 04: FY 03: FY 02: 1 approval FY 01: NA	4
5. Complete 95% of PMA "Determination" meetings within 30 days. (15024)	FY 04: 95% FY 03: 95% FY 02: 95% FY 01: 95% FY 00: 95%	FY 04: FY 03: FY 02: 100% of 1 FY 01: 100% of 3 FY 00: 100% of 3	3
6. Recognize 20 new or enhanced standards to use in application review. (15003)	FY 04: Recognize 20 new or enhanced standards to use in application review. FY 03: Recognize 20 new or enhanced standards to use in application review. FY 02: Recognize 20 new or enhanced standards to be used in application review. FY 01: Recognize 20 additional application review standards FY 00: Review 50Standards for continued applicability and 50 standards for recognition FY 99: Recognize over 415 standards for use in application review	FY 04: FY 03: FY 02: 657 Standardsrecognized FY 01: 597 Standards recognized FY 00: 567 Standards recognized FY 99: 450 StandardsRecognized	3
7. Conduct 295 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.) (15025)	FY 04: 295 FY 03: 295 FY 02: 290 FY 01: 250	FY 04: FY 03: FY 02: 360 FY 01: 238 FY 00: 249	3
TOTAL FUNDING: ($ 000)	FY 04: $ 92,115 FY 03: $ 77,891 FY 02: $ 77,766 FY 01: $ 74,164 FY 00: $ 64,698	Numbers in the Reference column corresponds to the relevant strategic goal in the HHS Strategic Plan

NOTES:
PMA first actions include: approval, approvable, approvable pending GMP inspection, not approvable, denial or "major deficiency letter.
PMA Supplement final actions include: approval, approvable, approvable pending GMP inspection, not approvable, or denial.
510(k) first actions include: SE, NSE, or "additional information" letter.
/1 Efficiency goals used as interim tracking while MDUFDA baseline data is collected. These goals are for review of submitted packages and may not result in a final decision by the FDA.

C. Goal-By-Goal Presentation of Performance

1. Complete Review and Action on 90 percent of Premarket Approval Application of an estimated 80 (PMA) first actions within 180 days. (15001)
Context of Goal: Complete review and action constitutes the comprehensive review of the application package initially received by FDA and FDA's response back to the product sponsor. 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. FDA anticipates significant complexity of PMAs. For example, many new devices will incorporate computer technology as part of the diagnostic capability of the device itself and continuing improvements in image technology will require more sophisticated review skills. In addition, 40 percent of PMA are breakthrough technologies and approximately 25 percent are from first-time submitters. These factors add time to the normal review process.
Performance: In FY 2001, FDA performance was 97 percent for the applications received in FY 2001. The performance strategy has been to redirect resources from low-risk to high-risk devices. However, in FY 2002, the Center's direct review effort was reduced by 20 FTEs and the projected performance goal for FY 2003 has been reduced from 95 percent to 90 percent. FY 2004 was projected based on being able to maintain the FY 2003 performance, the FDA will only be able to meet a 90 percent FY 2004 performance goal. If the user fee proposed increase is approved FA will be able to improve the performance listed in this document in the future. 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.
Data Sources: Center for Devices and Radiological Health (CDRH) Premarket Tracking System and Receipt Cohorts.

2. Complete Review and Action on 95 percent of Premarket Approval Application of an estimated 725 (PMA) supplement final actions within 180 days. (15009)
Note: workload will continue to increase in FY 2004 due to advances in technology.
Context of Goal: Complete review and action constitutes the comprehensive review of the application package initially received by FDA and FDA's response back to the product sponsor. 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 641 PMA supplements chose real-time reviews, mostly by teleconference.
Performance: FY 2002 performance was 94 percent for the applications received in FY 2002.
Data Sources: CDRH Premarket Tracking System and Receipt Cohorts.

3. Complete Review and Action on 95 percent of an estimated 4,500 510(k) (Premarket Notification) first actions within 90 days. (15002)
Context of Goal: Complete review and action constitutes the comprehensive review of the application package initially received by FDA and FDA's response back to the product sponsor. This is an FY 1999 goal, dropped in FY 2000, and picked back up for FY 2001, FY 2002, 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. Pressures to improve review time will increase in FY 2004 for two reasons: 1) rapid advances in device technology are expected to continue. Past history shows that the 510(k) average review time has increased 38.5 percent from FY 1994 to FY 2001. 2), FDA has exempted Class I lower risk devices from 510(k) review in order to streamline the review process. Because more complex Class II and Class III applications will constitute the future 510(k) workload it will also contribute to longer average review times, and a lower percentage reviewed within 90 days.
Performance: FY 2002, performance is 100 percent. This performance has resulted, in part, from FDA utilizing innovative ways to improve review efficiency. The two efforts listed under the heading of "Third Party Reviews" below are illustrative of FDA device review improvements. FDA encourages firms to use these regulatory options.
Data Sources: CDRH Premarket Tracking System and Receipt Cohorts.

• 3. 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/.
• 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 an estimated 5 Bioterrorism Diagnostic Medical Device Applications. (15028)
Context of Goal: 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 was a new performance goal for FY 2003. Work will continue in FY 2004.
Performance: This is a new goal for FY 2003 and therefore, has no performance history.
Data Sources: CDRH Premarket Tracking System and Receipt Cohorts.

5. Complete 95 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.
Performance: FY 2002, performance was 100 percent.
Data Sources: CDRH Premarket Tracking System and Receipt Cohorts.

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.
Performance: FDA recognized 60 standards in FY2002, 30 standards in FY 2001 and 117 standards in FY 2000 for a cumulative total of 657 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.
Data Sources: Standard status document reports.

7. Conduct 295 BIMO inspections with an emphasis on vulnerable populations (e.g., mentally impaired, pediatric, etc.). (15025)
Context of Goal: In FY 2004, FDA plans to conduct 295 BIMO Inspections, the same number as in FY 2003. 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.
Performance: This goal is a new reporting commitment in FY 2002, and FDA met this goal by conducting 360 inspections. In FY 2001, 238 BIMO inspections were conducted. FDA did not achieve its performance goal of 250 device bioresearch inspections because the program did not receive its full appropriation request in FY2001 reduced the number of Field staff available to do device bioresearch inspections.
Data Sources: CDRH Field Data Systems.

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 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 (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. However, FDA is facing challenges of eroding infrastructure that support the device review program.

Program Goal 2:
To protect the public health by keeping marketed products safe.

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 bio-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 grow to well 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 conducts inspections to protect the public from unsafe or ineffective medical devices or radiological products, and to verify medical device firms follow Good Manufacturing Practices (GMP). Inspections of devices fall into three categories: 1) Routine Surveillance; 2) Targeted Inspections: for approval to market high risk devices, adverse reaction incidents, or recalls; 3) Compliance Inspections: to collect evidence for enforcement. (Performance Goals 7 - 10)

Medical devices and electronic products are increasingly complex, and industry is growing domestically and internationally. Inspection coverage has decreased and domestic violation rates have increased. In FY 2002, FDA requested an appropriated funding increase for domestic inspections and additive user fees for foreign inspections and imports, but these increases did not enable FDA to meet statutory inspection requirements.

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.

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

FDA is responsible for addressing radiation safety for both medical and consumer products. For example, FDA issued a public health notification to emphasize the importance of correct radiation doses during computed tomography (CT) procedures. The overexposure of children or small adults during 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 we estimate 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. Radiation-induced skin burns are an example of a resurgence of an old radiation issue. Reports in the MDR database and medical literature show these injuries result from the use of fluoroscopy in conjunction with interventional procedures. FDA is also responsible for regulating an expanding inventory of overseas facilities, which contribute roughly 335 million foreign made products.

FDA will prioritize 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 Product 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 adjusted the performance goal downward from 125 facilities to 80 facilities. CDRH had to delay recruitment efforts this year to address various policy issues within the Agency, and to make major software changes to respond to new information technology security demands. FDA projects a MeDSuN network of 180 facilities in FY 2003, and will use increased resources in FY 2004 to expand the network of hospitals and nursing homes to 240 facilities. (Performance Goal 12)

CDRH and its MeDSuN contractors will coordinate with CDER to continue implementation of drug MeDSuN. MeDSuN is designed to train hospital personnel to accurately identify and report injuries and deaths associated with medical products. The MeDSuN model, currently designed to track and analyze adverse events due to medical devices, will be expanded to include drug products. Initial work included a feasibility and acceptability assessment of a small regional group of hospital pharmacists about incorporating MeDSuN and to integrate risk manager reporting on devices with the reporting of adverse drug events and medication errors by hospital pharmacists or other personnel. This is also described in the Drugs performance plan.

B.   Summary of Performance Goals

Performance Goals	Targets	Actual Performance	Reference
8. Utilize Risk management to target inspection coverage for Class II and Class Ill domestic medical device manufacturers at 20% of estimated 5,300. (15005.01)	FY 04: 20% FY 03: 20% FY 02: 20% FY 01: 17% FY 00: 22% FY 99: 26%	FY 04: FY 03: FY 02: 20% of 5,300 FY 01: 20% of 4,980 FY 00: 13% of 5,462 FY 99: 30% of 2,930	3
9. Maintain inspection and product testing coverage of Radiological Health industry at 10% of an estimated 2000 electronic products. (15027)	FY 04: 10% FY 03: 10% FY 02: NA FY 01: NA	FY 04: FY 03: FY 02: 5% of 2,000 FY 01: 10% of 2,000 FY 00: 10% of 2,000	3
10. Utilize Risk management to target inspection coverage for Class II and Class Ill foreign medical device manufacturers at 9% of estimated 2,500. (15005.02)	FY 04: 9% FY 03: 9% FY 02: 9% FY 01: 9% FY 00: 9% FY 99: NA	FY 04: FY 03: FY 02: 8% of 2,500 FY 01: 11% of 2,418 FY 00: 11% of 2,370 FY 99: 10% of 2,080	3
11. Ensure at least 97% of an estimated 8749 domestic mammography facilities meet inspection standards, with less than 3% with Level I (serious) problems. (15007)	FY 04: 97% FY 03: 97% FY 02: 97% FY 01: 97% FY 00: 97% FY 99: 97%	FY 04: FY 03: FY 02: 97% of 9008, with less than 3% (serious) problems. FY 01: 97% of 9262; but with 3.4% with Level I (serious) problems. FY 00: 97% of 9443FY 99: 97% of 9583	3
12. Expand implementation of the MeDSuN System to a network of 240 facilities. (15012)	FY 04: Build a MeDSun hospital network of 240 facilities. FY 03: Build a MeDSun hospital network of 180 facilities. FY 02: Implement MeDSuN by recruiting a total of 80 facilities for the network FY 01: Recruit a total of 75 hospitals to report adverse medical device events FY 00: Develop MeDSuN based on approximately 25 user facilities FY 99: Implement Pilot	FY 04: FY 03: FY 02:FDA recruited, trained and have functioned 80 facilities for the network FY 01: FDA began feasibility testing with 25 hospitals and worked on software changes needed for website health data security. FY 00: Developed MeDSuN Phase II Pilot based on approximately 25 user facilities. FY 99: PilotCompleted	3
13. Implement Emergency Counterterrorism Preparedness and Response Plan for radiation. (15029)	FY 04: Implement Emergency Counterterrorism Preparedness and Response Plan for radiation. FY 03: Implement Emergency Counterterrorism Preparedness and Response Plan for radiation. FY 02: Develop Emergency Counterterrorism Preparedness and Response Plan for radiation.	FY 04: FY 03: FY 02: Developed Emergency Counterterrorism Preparedness and Response Plan for radiation.	4
14. Begin to develop radiation standards for the safety of novel or new technology used to scan people in airports and other places. (15030)	FY 04: Continue to develop radiation standards for the safety of novel or new technology used to scan people in airports and other places. FY 03: Begin to develop radiation standards for the safety of novel or new technology used to scan people in airports and other places. FY 02: NA FY 01: NA	FY 04: FY 03: FY 02: NA FY 01: NA	4
TOTAL FUNDING: ($ 000)	FY 04: $124,614 FY 03: $128,749 FY 02: $115,891 FY 01: $103,401 FY 00: $105,559	Numbers in the Reference column corresponds to the relevant strategic goal in the HHS Strategic Plan

C.   Goal-By-Goal Presentation of Performance

8. Utilize Risk management to target inspection coverage for Class II and Class III domestic medical device manufacturers at 20 percent of estimated 5,300. (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. The inventory of Class II and III medical device firms is estimated at 5,304. In FY 2002, the Center has developed an estimated inventory of 1,009 High/Significant Risk devices based largely on the Center's established critical device list. These high/significant risk devices (e.g., Cardiovascular Heart Valves) have been targeted for inspections in FY 2004. Reuse inspections have been incorporated into the domestic high/significant risk inventory. FDA plans to conduct 100 reuse hospital inspections in FY 2004, 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. By FY 2003, 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.
Performance: In FY 2002, FDA met its performance target by inspecting 1062, or 20 percent, of approximately 5.300 domestic high risk Class II and Class III medical device 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 firms.
Data Sources: CDRH Field Data Systems.

9. Maintain inspection coverage and product testing coverage of the Radiological Health industry at 10 percent of an estimated 2,000 electronic products. (15027)
Context of Goal: 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. 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 5,000 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.
Performance: This is a new goal for FY 2003. In FY 2002, FDA estimates there were approximately 2,000 active radiological health firms FDA is responsible for regulating domestically and internationally. In FY 2002, CDRH was able to check the compliance status for about 5 percent of these firms, by reviewing inspection reports and product testing reports submitted by manufacturers. FDA initiated activities to prioritize and leverage its radiation protection efforts with state governments, professional societies, and other federal agencies. This compliance status was estimated by CDRH's Office of Compliance by reviewing inspection reports from FDA and State inspectors and product testing reports submitted by industry.
Data Sources: CDRH Radiological Health Data Systems.

10. Utilize Risk management to target inspection coverage for Class II and Class III foreign medical device manufacturers at 9 percent of an estimated 2,500 firms. (15005.02)
Context of Goal: The foreign higher risk Class II and III inventory is expected to continue to increase. As workload increases, inspection coverage is expected to be 9 percent in each of FY 2002, FY 2003 and FY 2004. 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 will be maintain foreign inspections or successfully implement the MRA with. 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.
Performance: FDA met its FY 2002 performance goal of inspecting 8 percent of registered foreign Class II and Class III Medical Device manufacturers. In FY 2002, FDA foreign inspection rate was 8 percent and 209 inspections were conducted compared to 266 inspections conducted in FY 2001. FDA did not reach the 9% coverage goal since international climate post '9/11/01' adversely impacted foreign travel. The compliance program is focused on the improvement of enforcement actions by redirecting current resources to high?risk devices such as implants.
Data Sources: CDRH Field Data Systems.

11. 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 improve the quality of mammography in the United States. In the Mammography Quality Standards Reauthorization Act (MQSRA) 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 was implemented in 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 89 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.
Performance: During FY 2002, FDA ensured that 97 percent of mammography facilities met inspection standards and with less than 3 percent with Level 1 (serious) problems. This was the fourth consecutive year of achieving this high standard. Inspection data continue to show facilities' compliance with the national standards and with the quality for 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.
Data Sources: CVM's priority project tracking system.

12. Expand implementation of the MeDSuN System to a network of 240 facilities. (15012)
Context of Goal: FDAMA gives FDA the option to replace universal user facility reporting with the Medical Product 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 mis-use. 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. Data collection began in March 2002 and continues to date, along with recruitment of participating centers. By the end of 2003 we will have recruited 180 facilities. For 2004, with increased funding, FDA will be able to expand the enrollment of 240 facilities. FDA will recruit new facilities to expand the network and to replace those that choose to leave. Additionally, FDA plans to use the cohort of 240 facilities to pilot the effectiveness of various incentives, to pilot use of the MeDSuN facilities as a laboratory to obtain specific medical product information, and to pilot various types of feedback intended to encourage reporting by the facilities.
Performance: In FY 2002, FDA recruited, trained and had functioning 80 facilities for the network. In FY 2001, FDA did not meet the goal of recruiting 75 hospitals because most of the effort was focused on resolving internal policy issues and addressing information technology security requirements. During the past year, FDA extended software development to accommodate Internet-based reporting system (interactive web-based form and database), and took steps to ensure that reporters had internet access to secure servers. FDA did recruit 25 hospital facilities.
Data Sources: CDRH Adverse Events Reports.

13. Implement Emergency Counterterrorism Preparedness and Response Plan for radiation. (15029)
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 Counterterrorism funds, CDRH will update the radiation emergency response plan to include Counterterrorism events. In FY 2004, CDRH will initiate contracts with Federal, State, and independent 3rd party laboratories to conduct safe use requirements and to conduct risk assessment. CDRH will also continue emergency preparedness activities in the area of radiation safety. Specifically, CDRH continues to monitor, evaluate and follow-up on the public health needs of new medical devices or their use in Counterterrorism preparedness and response and regulate them appropriately. CDRH is working with other Federal and State agencies to address mail decontamination issues and CDRH has participated in developing the new standard for X-Ray screening. Additionally, the center is in the process of classifying diagnostic test kits used to detect biological agents based on FDA's Microbiology Devices panel recommendations. The Center is also expanding technical assistance to industry and the DOD to expedite, review, and expand outreach to civilian emergency medical professionals and provide more information about new devices in their field.
Performance: This was a new goal for FY 2003 and therefore, has no performance history. In FY2002, FDA Developed Emergency Counterterrorism Preparedness and Response Plan for radiation.
Data Sources: CDRH's radiation emergency preparedness response plan.

14. Begin to develop radiation standards for the safety of novel or new technology used to scan people in airports and other places. (15030)
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 Counterterrorism resources. FDA will work with the other stakeholders to maximize benefit of FDA's limited resources in this area.
Performance: This is a new goal for FY 2003 and therefore, has no performance history.
Data Sources: CDRH standard setting documents.

Contact Information:
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Phone: 301-827-5210

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