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FDA Issues Analysis of Premarket Review Times Under 510(k) Program

The FDA’s 510(k) procedure is the most common regulatory review pathway for medical devices to reach the market. In response to recent reports sponsored by the medical device industry that the amount of time the FDA  takes to complete premarket review applications for medical devices, the FDA issued an analysis of such applications and the causes of the delay. The analysis acknowledges that the time to complete 510(k) reviews has increased from 90 days in 2005 to 140 days in 2010, an increase of over 50 percent. Nevertheless, FDA contends that “FDA is meeting or exceeding its goals for 510(k) review times agreed to with industry under the Medical Device User Fee Act (MDUFA)” because the delay is largely  attributable to poor quality submissions by manufacturers. 

The FDA analysis states that the primary reason for the additional review time is applicant delay in responding to FDA requests  for additional information (AI). Further, the number of times per application the FDA seeks additional information and the percentage of applications in which it requests additional information has also increased. To determine the cause of the increased AI letters, the FDA studied two “cohorts” of AI letters, one related to incoming submission quality (Cohort 1) and one for the increased number of  AI letters per application (Cohort 2). The FDA determined that 83 percent of the letters in Cohort 1 and 82 percent of the letters in Cohort 2 were issued because of a poor quality submission as defined in the report. 

Further, in Cohort 1, 52 percent of the quality issues involved the device description, i.e., the sponsor either did not provide sufficient information about the device to determine what it was developed to do, or the device description was inconsistent throughout the submission. According to FDA, the Cohort 2 analysis showed that roughly 50 percent of submissions that received at least one AI letter lacked an adequate device description. The Cohort 2 analysis also showed that a second AI letter was most often sent because the applicant’s response to the first letter was incomplete or because the response raised new questions, such as safety questions based on test results submitted with the first letter. Other common deficiencies included problems with indications for use, failure to follow or otherwise address current guidance documents or recognized standards, or missing performance testing and required clinical data for certain devices. 

The FDA did acknowledge some contribution to the problem. The Cohort 1 analysis showed that 8 percent of the FDA reviewers’ requests for information were inappropriate and the Cohort 2 analysis showed that 2 percent of the requests were inappropriate. The FDA also stated that it is taking steps, including enhanced  training for its reviewers and for industry, to reduce the total review time.

The full text of the FDA’s analysis can be found at the following website: www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm263385.htm

© 2022 BARNES & THORNBURG LLPNational Law Review, Volume I, Number 272
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About this Author

Lynn C. Tyler FDA Compliance Attorney Barnes & Thornburg
Partner

Lynn Tyler helps innovative companies secure and preserve their market position and competitive advantage. He advises on FDA compliance, helps protect clients with patent infringement and validity opinions, helps and enforce intellectual property rights — which often must be asserted against imitators who seek to reap where they have not sown.

An accomplished advocate, Lynn litigates and represents clients involved in virtually all stages of the dispute resolution process, including pre-litigation counseling, alternative dispute resolution, formal and informal...

317-231-7392
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