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Medical Devices Performance Goals

The following performance goal table summarizes the performance goals, yearly targets and actual reported data for the Medical Devices Program. 

Given the uncertainty of final FY 2007 appropriation levels at the time FDA developed the performance targets for the FY 2008 Congressional Justification, FDA has included FY 2007 targets at both the President's Budget and the Continuing Resolution funding levels.

NOTE: The MDUFMA review goals are based on FDA review time only, and do not include time that elapses when the sponsor is responding to questions or issues raised by FDA.  This means that FDA cannot determine exactly when all the applications in a review cohort will be completed.  The actual results reported for this goal are as of the times noted, and as the final applications in the cohort are resolved, small changes to previously reported results may occur.

1. Complete Review and Decision on 90% of Expedited PMAs within 300 days; and Review and Decision on 90% of Original Premarket Approval (PMA), Panel-track PMA Supplement, and Premarket Report Submissions of received within 320 days.  (15033)

• Context of Goal:  Complete decision constitutes the comprehensive review of the application package initially received by FDA and FDA's decision letter.  PMAs involve potentially high-risk devices with the most chance of significantly improving the treatment of patients.  The steps taken in MDUFMA that will reduce approval times for PMA applications are expected to reduce approval times for all filed applications, while recognizing that some applications may not ultimately meet FDA's standards for safety and effectiveness and that performance measures based on all applications will take more time to observe. 

The MDUFMA legislation includes a required statutory minimum "trigger" amount of funds that must be appropriated each year for FDA's medical device and radiological health program; if this appropriation trigger is not met, FDA is not authorized to collect and spend user fees.  The FY 2008 budget authority request for the medical device program will allow FDA to continue to collect and spend MDUFMA user fees. 

In FY 2008, FDA will continue its efforts to reduce unnecessary cycles in the review of applications. For example, MDUFMA encourages more pre-submission meetings and guidance documents provided, especially for expedited products. FDA uses these interactions with sponsors to clarify requirements and improve the quality of applications so that there are fewer cases where FDA needs to stop the review clock and go back to sponsors to ask for more information.  Real time reviews will be will also be maintained.  FDA will also leverage with outside experts through the medical device fellowship program, which brings in trained academic experts to work for FDA for limited periods of time. 

In FY 2008, the FY 2008 target levels agreed to in the MDUFMA legislation for this goal will be achievable at the President's Budget funding level.  This will result in performance targets of 90% for Expedited PMA and 90% for Original PMA submissions.

At the time this budget was developed, the terms of legislation to reauthorize MDUFMA for another 5 years were still under discussion with stakeholders, as required under section 105 of MDUFMA.  This request assumes the conditions now in effect for the last year of MDUFMA I will continue in FY 2008. 

• Performance: CDRH is currently on pace to exceed agreed upon performance for this goal in FYs 2005 and FY 2006.  The current baseline for FDA decision time for standard PMAs is 320 days.  MDUFMA resources will be used both for new hires and to expand external expertise.

MDUFMA review goals are based on FDA review time only, and do not include time that elapses when the sponsor is responding to questions or issues raised by FDA.  This means that FDA cannot determine exactly when all the applications in a review cohort will be completed.  The actual results reported for this goal are as of the times noted, and as the final applications in the cohort are resolved, small changes to previously reported results may occur.

2. Complete Review and Decision on 90% of 180-day PMA supplements within 180 days.  (15031)

• Context of Goal: Complete decision constitutes the comprehensive review of the application package initially received by FDA and FDA's decision letter.  A decision will result in one of the following designations for each application: approval, approvable, approvable pending GMP inspection, not approvable, denial.  PMAs 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.  The MDUFMA legislation includes a required statutory minimum "trigger" amount of funds that must be appropriated each year for FDA's medical device and radiological health program; if this appropriation trigger is not met, FDA is not authorized to collect and spend user fees.  In FY 2008, the FY 2007 target level agreed to in the MDUFMA legislation for this goal will be achievable at the President's Budget funding level.  FDA plans to maintain performance at 90% for 180-day PMA supplement submissions.  At this level FDA will continue real time meetings which are conducted by teleconference or face-to-face to augment standard communications with industry.

At the time this budget was developed, the terms of legislation to reauthorize MDUFMA for another 5 years were still under discussion with stakeholders, as required under section 105 of MDUFMA.  This request assumes the conditions now in effect for the last year of MDUFMA I will continue in FY 2008. 

• Performance:  CDRH is currently on pace to exceed agreed upon performance for this goal in FYs 2005 and FY 2006.  CDRH expects to begin reporting performance on this goal in FY 2007. 

MDUFMA Review goals are based on FDA review time only, and do not include time that elapses when the sponsor is responding to questions or issues raised by FDA.  This means that FDA cannot determine exactly when all the applications in a review cohort will be completed.  The actual results reported for this goal are as of the times noted, and as the final applications in the cohort are resolved, small changes to previously reported results may occur.

3. Complete Review and Decision on 80% of 510(k)s (Premarket Notifications) within 90 days. (15032)

• Context of Goal: Complete decision constitutes the comprehensive review of the application package initially received by FDA and FDA's decision letter.  A decision will result in one of the following designations for each application: substantially equivalent or not substantially equivalent.  This goal for review and decision on 510(k)s within 90 days addresses the statutory requirement to review a 510(k) within 90 days.  The MDUFMA legislation includes a required statutory minimum "trigger" amount of funds that must be appropriated each year for FDA's medical device and radiological health program; if this appropriation trigger is not met, FDA is not authorized to collect and spend user fees.  In FY 2008, the FY 2007 target level agreed to in the MDUFMA legislation for this goal will be achievable at the President's Budget funding Level.  CDRH will maintain performance will be maintained at 80% for 510(k) submissions.

At the time this budget was developed, the terms of legislation to reauthorize MDUFMA for another 5 years were still under discussion with stakeholders, as required under section 105 of MDUFMA.  This request assumes the conditions now in effect for the last year of MDUFMA I will continue in FY 2008. 

• Performance:  CDRH is currently on pace to exceed agreed upon performance for this goal in FYs 2005 and FY 2006. 

MDUFMA Review goals are based on FDA review time only, and do not include time that elapses when the sponsor is responding to questions or issues raised by FDA.  This means that FDA cannot determine exactly when all the applications in a review cohort will be completed.  The actual results reported for this goal are as of the times noted, and as the final applications in the cohort are resolved, small changes to previously reported results may occur.

4. Focus inspectional coverage on the device research enterprise to assure the protection of human research subjects, the quality and integrity of research, and the advancement of new medical technologies. (15025)

• Context of Goal:  For FY 2007, this performance goal was revised to reflect the change in the selection of firms for inspection to a more risk based approach.  It is estimated that approximately 15,000 sites conduct significant risk device research in the United States.  A FDA-regulated research community that consists of Clinical Investigators, Sponsors and Monitors, and Institutional Review Boards share responsibility to oversee this research in a truthful and ethical manner.  FDA expects to direct available FY 2007 inspectional resources to the following areas:
  • Directed inspections of the device research community to assure high quality and ethical research methods while the Pre-Market Approval application (PMA) is under review.
  • Early intervention inspections of the device research community (e.g., focusing on studies during active research on vulnerable populations, with novel technology, etc.) to assure high quality and to assure that human subjects' rights and welfare are protected.
  • Inspections initiated to investigate complaints of unethical or substandard device research practices and re-inspection of previously violative sites to assess improvements in research practices.
  • Surveillance inspections of the regulated research community using a risk-based approach for triaging and selecting sites.
• Performance:  In FY 2006, FDA exceeded this goal of 295 by conducting 336 medical device related BIMO inspections. 

5. Reduce the average time for marketing approval for safe and effective new devices.

• Context of Goal: MDUFMA commits FDA to significant improvements in device review performance. This is important to the entire device industry, which is expanding in size and technical complexity. The industry is relying on FDA to take a leadership role in regulating a rapidly emerging frontier of medical device technology with timeliness, quality, scientific consistency, and international harmonization. Most of the device industry is small and rapidly changing. Many small and new start-up firms rely heavily on FDA for guidance and outreach, and the reviews from these firms take extra FDA time and energy.
  • About 25 percent of PMAs are for breakthrough technologies; and
  • Over 25 percent of PMAs are from first-time submitters.

The area of expedited devices is particularly important because they are the most complex, raise new medical and scientific issues, and FDA often works with first time or small device sponsors. These devices are for uses that haven't been approved yet, and could have great clinical impact. Our expedited program is the area where we have the most improvements to make.

Standard PMAs are also for the most complex (Class III) devices, and also have significant clinical impact.  For example, a drug-eluting cardiac stent could, if used properly, reduce repeat angioplasty of bypass surgery by 15-30 percent.

The implementation of MDUFMA allowed FDA to take steps to improve its device review program by analyzing the application review process to change its internal business models.  CDRH currently uses these interactions with sponsors to clarify requirements and improve the quality of applications. FDA is also taking steps to improve the quality of reviews. CDRH piloted an after the fact quality review system to review a sample of reviews to assess the quality of the review and the scientific consistency of the review process and the review decision. The result of this study was made available at the end of FY 2005. This information was shared with reviewers to improve reviews.  FDA also uses guidance to industry and reviewers to improve the quality of submissions, making the review process more predictable.

• Performance:  The FDA approval time for the fastest 50 percent of Expedited PMAs approved for the FY 2001-2003 cohort is 275 days compared to 360 days for the baseline FY 1999-2001 submission cohort. This is a reduction of 85 days versus the FY 2005-2007 target reduction of 30 days.  CDRH initially calculated the baseline data for this goal, time to approval for the fastest fifty percent of expedited PMAs, for the time period of FYs 1999 "“ 2001.

MDUFMA review goals are based on FDA review time only, and do not include time that elapses when the sponsor is responding to questions or issues raised by FDA.  This means that FDA cannot determine exactly when all the applications in a review cohort will be completed.  The actual results reported for this goal are as of the times noted, and as the final applications in the cohort are resolved, small changes to previously reported results may occur.

6. Ensure at least 97% of an estimated 8,900 domestic mammography facilities meet inspection standards, with less than 3% with Level I (serious) 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.  Under the Mammography Quality Standards Act (MQSA, which was reauthorized in 2004), annual MQSA inspections are performed by trained inspectors with FDA, with State agencies under contract to FDA, and with States that are certifying agencies.  State inspectors conduct approximately 90 percent of inspections.  Inspectors perform science-based inspections to determine the radiation dose, to assess phantom 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 employs an extensive outreach program to inform mammography facilities and the public about MQSA requirements.  These include: an Internet website, collaboration with NIH to provide a list of MQSA-certified facilities, and a toll-free facility hot line.  In FY 2008, FDA will ensure at least 97% of an estimated 8,900 domestic mammography facilities meet inspection standards at the President's Budget Funding level.
• Performance:  FDA met this goal in FY 2006 by ensuring that 97 percent of an estimated 8,900 mammography facilities met inspection standards with less than 3 percent level 1 (serious) problems.  Inspection data continue to show facilities' compliance with the national standards for the quality of mammography images.  Improving the quality of images should lead to more accurate interpretation by physicians and, therefore, to improved early detection of breast cancer.  FDA works cooperatively with the States to achieve this goal.

7. Focus inspectional coverage on device firms to ensure consumers are protected and that the public health is advanced. (15005) 

• Context of Goal:  In FY 2007 it is expected that the inventory of Class II and Class III foreign and domestic firms will approximate 8,100 firms. The ultimate  goal of preventing unsafe and ineffective devices from  reaching the consumer will be advanced in FY 2007 by detecting and intercepting unsafe and ineffective product at the manufacturing level  through inspectional accomplishments in the following areas:
  • Inspections by assignment of manufacturers which are determined to be high risk by the Center for Devices and Radiological Health (CDRH) based upon their determination of the probability, severity and occurrence of harm to a consumer, coupled with a determination of the complexity of the device.
  • Inspections of manufacturers undergoing significant recalls, or significant adverse event reporting, to determine the root cause of the event and to limit consumer exposure.  Significance is assessed by classification of the recall as a Class 1 recall or an event determined to be equivalent through a Health Hazard Evaluation performed by CDRH.
  • Inspectional follow up at manufacturers previously determined to be out of compliance with the Quality System regulation.  Compliance with the regulation is necessary to ensure that safe and effective finished devices reach the consumer.
  • Inspections of foreign firms which are exporting significant devices or significant quantities of devices into the United States to reduce potential harm and exposure to the consumer.
  • Inspections of manufacturers to determine if they continue to produce safe and effective medical devices, after they have been impacted by a major natural disaster, such as a flood or earthquake. 
  • Assessment inspections of firms, prior to the approval of their pre-market application.  This is to ensure that firms are producing Class III devices (i.e., devices that are life-sustaining and life-supporting and those posing the greatest risk) consistent with the application being reviewed for approval, and to ensure that the requirements under the Quality Systems regulation are met, in order to minimize consumer risk to new products with no prior commercial marketing history. 
• Performance:  FDA exceeded the FY 2006 medical device performance goal of 1,234 by inspecting 1,299 foreign and domestic high-risk Class II and Class III medical device manufacturers. 

8. Protect the public health by monitoring adverse events through the Medsun Network. (15012)

• Context of Goal:  FDAMA gives FDA the mandate to replace universal user facility reporting with the Medical Product Surveillance Network (MedSun) that is composed of a network of user facilities that constitute a representative profile of user reports.  MedSun is a critical component in increasing the percent of the population covered by active surveillance, which will allow for more rapid identification and analysis of adverse events. 

FDA is using MedSun to 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 designed to train hospital personnel to accurately identify and report injuries and deaths associated with medical products.  Data collection began in March 2002 and continues to date, along with recruitment of participating centers.  In FY 2005, FDA expanded the network to 354, and replaced those facilities that chose to leave.  This completed the planned expansion of the network to the total target number specified in the initiative.  In FY 2006, FDA turned its focus to increasing the number of active facilities (facilities that have been enrolled for longer than a year and submit at least one report per year). 

The goal for FY 2007 will be to increase the number of facilities that are actively participating in the MedSun Network from 71% to 90% of a cohort of 340 facilities.  At the FY 2008 President's funding level, FDA will further expand the number of facilities that are actively participating in the Medsun Network to 95%, and increase the cohort to 375 total facilities participating in the network.  FDA will also commit to the following Medsun related targets in FY 2008:

• The number of children's hospitals, and neonatal and pediatric intensive care units under MedSun's active surveillance for device problems increases by 22%.
• The total number of hospitals under MedSun's active surveillance for device problems increases by 7%.
• MedSun reports on problems with the use of devices in pediatric populations increases by 10%.
• MedSun special studies to verify, understand and validate device problems and problem solutions increases by 30%.

• Performance:  In FY 2006, FDA expanded actively participating sites in MedSun Network to 86% and maintained a cohort of 350 facilities.

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