December 11, 2019

December 11, 2019

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December 10, 2019

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December 09, 2019

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Recent Reports Claim Improvements in FDA’s Review of Medical Device Submissions

Two recent reports cite gains made by the Center for Devices and Radiological Health (CDRH) in strengthening the clinical trial enterprise and shortening the review times for marketing applications for medical devices.  The reports suggest that CDRH’s review processes are becoming more efficient, and that on average applicants can expect shorter review times for investigational device exemption (IDE) submissions, premarket approval (PMA) applications, and premarket notification (510(k)) applications, relative to years past.

In its 2014–2015 Strategic Priorities, CDRH announced that it intended to strengthen and streamline its review process related to clinical trials.  CDRH announced two specific goals to support this effort: (1) improve the efficiency, consistency, and predictability of the IDE process to reduce the time and number of cycles needed to reach appropriate IDE full approval for medical devices, in general, and for devices of public health importance, in particular; and (2) increase the number of early feasibility/first-in-human IDE studies submitted to FDA and conducted in the United States.  CDRH set various targets over the course of 2014 and 2015 to achieve these goals.

On September 24, 2015, CDRH issued an update on its progress.  Overall, CDRH claims to have met its clinical trial program goals.  For example, the report states that:

  • CDRH had reduced the number of IDEs requiring more than two cycles to an appropriate full approval decision by 53% compared to FY 2013 performance.  The goal had been a 50% reduction.  For FY 2015, 73.5% of IDE studies were fully approved within two cycles as compared to 14.8% in FY 2011.

  • CDRH had reduced the overall median time to full appropriate IDE approval to 30 days, meeting its goal.  In 2011, the median number of days to full IDE approval was 442 days.

  • CDRH had increased the number of early feasibility/first-in-human studies submitted to each premarket Division compared to FY 2013.  Specifically, there was a 50% increase in the number of early feasibility study submissions, and a 100% increase in the number of approvals, for the first nine months of FY 2015 compared to FY 2013.

Also, on October 15, 2015, the California Life Sciences Association and Boston Consulting Group—with cooperation from FDA—released an infographic report titled “Recent Trends in FDA Medical Device Regulation.”  The report addresses trending data about the medical device review process over the last fifteen years, including PMA review times, 510(k) decision times, and variation in performance across CDRH’s review divisions and branches.  The report found that:

  • PMA average review times have declined steadily since FY 2010, with the exception of FY 2013 when there was a notable uptick in the percentage of devices referred for panel review (36% in 2013 versus 8% in 2012).  PMA average review times for FY 2014 are likely to reach their shortest time since 2000.

  • Although they are still above historic averages, 510(k) decision times have decreased over the last three fiscal years and the backlog has decreased.

  • While previously review division and branches varied significantly in meeting MDUFA PMA and 510(k) performance goals, recent overall performance improvements have also resulted in more consistent performance across the Center.

These reports suggest that CDRH has made strides in improving its IDE and marketing application review processes over recent years.  If sustained, these efforts should improve the predictability and timeliness of FDA reviews of medical device submissions going forward.

© 2019 Covington & Burling LLP


About this Author

Julia Post, Food and drug attorney, Covington

Julia Post advises biotechnology, pharmaceutical, medical device, and trade association clients on a variety of federal and state regulatory and compliance matters. In particular, Ms. Post has experience in areas including biosimilars and interpretation and implementation of the Biologics Price Competition and Innovation Act of 2009; human cells, tissues, and cellular and tissue-based products (HCT/Ps); market exclusivity; informed consent requirements; and pharmacy substitution practices.

Prior to joining the Food and Drug practice group, Ms. Post was a member of...