Oct 24, 2012

The US Food and Drug Administration has set new review timeframes and performance goals for 510(k) premarket notification reviews of medical devices following Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. By 2017, the agency intends to reduce the average total time for 510(k) decisions to 124 days from 150 days for fiscal year 2012.

The agency has published guidance explaining regulatory performance goals and 510(k) review process improvements planned for fiscal years 2013 through 2017. These goals are intended to allay industry concerns that the FDA’s 510(k) review process has become too lengthy and complicated.

Key performance goals
Through fiscal year 2012, performance goals in terms of FDA 510(k) review timeframes included the following: clearance decisions within 90 days for 90% of submissions received in 2012, and 150 days for 98% of submissions. Starting in 2013, the FDA intends to lower those review times—but those improved review times depend on new obligations on both the regulator and 510(k) applicants under MDUFA III.

  • 510(k) Submissions: All 510(k) submissions will have to include user fees stipulated in MDUFA III.
  • Acceptance Review: The FDA will conduct a preliminary Acceptance Review within 15 calendar days of receiving a 510(k) application to determine if the submission can proceed to the Substantive Review phase. Within this 15-day period, FDA reviewers will notify applicants of any Refuse to Accept (RTA) decisions if submissions are incomplete; submissions subject to RTA decisions will be put on hold until applicants provide missing information.
  • Substantive Interaction: The FDA will conduct Substantive Reviews of 510(k) applications once those applications have passed the Acceptance Review phase. An applicant will be notified within 60 calendar days of Substantive Interaction—meaning either that reviewers have determined Substantial Equivalency for their device, issued a request for additional information (AI) or will proceed with an Interactive Review to resolve any issues or deficiencies with the applicant’s submission.
  • Limited Extensions: Only two rounds of review are planned for 510(k) submissions starting in the 2013 fiscal year: the original submission review and any request for additional information (AI). Furthermore, the agency will grant only one 180-day extension in the event of an AI request.

Total Time to Decision Goals
Given the performance goals listed above, the FDA seeks to reduce decision timeframes steadily between 2013 and 2017. 



Review Time

FY 2013

FY 2014

FY 2015

FY 2016

FY 2017

Substantive Interaction

60 Days

65% of 510(k)s

75% of 510(k)s

85% of 510(k)s

95% of 510(k)s

95% of 510(k)s

SE/NSE Decision

90 Days







The agency seeks to reduce total decision timeframes for 510(k) submissions to 135 days in 2013 and 2014, 130 days in 2015 and 2016, and 124 days in 2017.

MDUFA III also authorizes the FDA to add staff in order to better manage regulatory activities, so it is conceivable that with additional employees and resources, the agency can meet these timeframes. Whether or not these steps placate industry complaints of overlong and unpredictable review processes is another story.


  • Stewart Eisenhart