Archive
Food and Drug Administration Reinvention Goal:
Faster Access to Important New Medical Devices
Status Report: August 2000
Initial Goal Statement (December, 1997):
By the year 2000, reduce the review time for important medical devices by 30 percent. (Important medical devices are products that present a major clinical benefit or those that may pose a significant risk to patients). This will be accomplished by reinventing the screening and review process for product applications. The impact of this goal is that millions of Americans will have faster access to safe and effective medical devices. FDA is reinventing the medical device review process and redefining the concepts of high risk and high impact products. The new definition will be applied to establish a baseline to measure review time for important medical devices.
Current Goal Statement:
By the year 2000, reduce the review time for important medical devices by two-thirds or 67 percent. (Important medical devices are products that present a major clinical benefit or those that may pose a significant risk to patients). This will be accomplished by reinventing the screening and review process for product applications. The impact of this goal is that millions of Americans will have faster access to safe and effective medical devices. FDA is reinventing the medical device review process and redefining the concepts of high risk and high impact products. The new definition will be applied to establish a baseline to measure review time for important medical devices.
Date of Revision:
August 2000
Forecast Completion Date:
April 2001. The goal is based on the FY 2000 receipt cohort of applications, those received in FY 2000. An application could be received on the last day of FY 2000 and could take up to 180 days or more to complete. Therefore, a final accounting of the goal may not be possible until approximately six months after the end of FY 2000.
Status:
FDA's medical device premarket strategy is to redirect resources to high-risk and high-impact product areas while reengineering the device review process. These strategies are in accordance with requirements outlined in the FDA Modernization Act (FDAMA). The goal of a 67 percent reduction in review time is measured by the increase in the percentage of the number of important medical devices reviewed within statutory time frames.* To reach this goal would require increasing the percentage of PMAs reviewed on time, from 51 percent achieved in FY 1996 to 85 percent by the year 2000. The revised goal is based on the final FY 2000 appropriation, which includes an increase of $7 million over FY 1999 for premarket activities. Final FY 1999 performance was 74% of PMAs reviewed on time.
* Important medical devices are those requiring a premarket approval application (PMA). Review time is measured from the time of application receipt until a first action is taken (either approval of the application or identification of deficiencies that require further response from the applicant). By statute, FDA must review PMAs within 180 days.
Location in FY 1999 Strategic Plan:
HHS Objective 6.5: Accelerate private-sector developing of new drugs, biologics, therapies, and medical technology.
Location in FY 1999 Performance Plan:
Goal Statement: Complete 50 percent of PMA first actions within 180 days.
Location in FY 2000 Performance Plan:
Goal Statement: Increase the on-time percentage of Premarket Approval Application (PMA) first actions (within 180 days) and Humanitarian Device Exemption (HDE) first actions (within 75 days) completed from 67 percent in FY 1998 to 85 percent in FY 2000 and 95 percent by FY 2002. (Page 100, Medical Device Goal 1.)
Location in FY 2001 Performance Plan:
Goal Statement: Increase the on-time percentage of Premarket Approval Application (PMA) first actions (within 180 days) and Humanitarian Device Exemption (HDE) first actions (within 75 days) completed to 85 percent in FY 2000. (Page 114, Medical Device Goal 1.)