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The Food and Drug Administration (FDA) announced today a new goal for reducing the total amount of time that medical devices remain under review by the Agency.
As a result of the improvements in device application review times that will be possible through the additional resources provided under the Medical Device User Fee and Modernization Act (MDUFMA), the FDA is committing to reduce the cumulative review time that the agency requires to approve expedited and traditional Pre-Market Approval Applications (PMAs). The FDA will accomplish this goal by working with sponsors to implement MDUFMA to improve the quality of the applications they submit to FDA, and to improve the efficiency of the process for providing and reviewing evidence on the safety and effectiveness of new medical devices. This will permit FDA to reduce the number of cycles and time that sponsors and the Agency spend in developing and reviewing additional information, and will allow the agency to devote relatively more effort to applications that can be reviewed quickly.
This announcement, which is part of FDA’s strategic action plan, represents the first time that FDA has publicly committed to reducing total review time for medical device products that can be approved. This complements the agency’s commitment under MDUFMA to reduce cycle and decision times for all new device reviews. This new effort is similar to commitments the agency has already made to reduce the cumulative review time for generic drugs and new drugs and biologics.
Specifically, for both expedited and traditional PMAs, the FDA is committing to reduce its review time by 30 days for the fastest 50% of those applications approved for FYs 2005 through 2007. The baseline for this goal is the three year average of FDA’s time for the fastest 50% of approved PMAs for the applications filed during FY 1999-2001.
By looking at the fastest 50 percent of applications filed and approved over a period, the agency will be able to get an early measure of its performance, without waiting for every application to complete the review process. The steps that will reduce approval times for the fastest 50 percent of applications are expected to reduce approval times for all ultimately acceptable applications, while recognizing that many 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 agency is measuring its performance toward achieving this goal over a three year time period because the FDA believes that the full effect of these efforts to reduce cumulative review time will be best measured after MDUFMA has been fully implemented.
The FDA will achieve these reductions in cumulative approval time by reducing unnecessary cycles, through encouraging and supporting higher-quality applications and more efficient resolution of outstanding issues.
For example, MDUFMA encourages more pre-submission meetings, especially for expedited products. CDRH will use 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. FDA is also using a collaborative process with outside experts both in and out of government to develop clearer guidance in important and emerging new areas of device development, such as treatments for diabetes and cancer, and novel drug delivery systems and tissue therapies.
FDA is also taking steps to improve the quality of reviews. As one such step, CDRH will develop an after the fact quality review system to evaluate a sample of reviews to assess the quality of the review and the scientific consistency of the review process and the review decision. This information will be shared with reviewers to improve the process.
The agency’s new goal to reduce approval times is intended to complement the progress made through MDUFMA. MDUFMA makes available new revenue for completing more timely and complete reviews. Medical device user fees are targeted specifically to enhance FDA’s device review program to meet review cycle and decision goals and ultimately help reduce the time for marketing approval for safe and effective new devices. Legislation requiring user fees was passed as part of last year’s Medical Device User Fee and Modernization Act (MDUFMA).
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