On October 15, the FDA published guidance regarding new efforts to reduce the average total wait time for 510(k) decisions from an average of 150 days in FY 2012 to 124 days in FY 2017. They will seek to do this by hiring more reviewers and investing more resources, both made possible by the Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year.
The strategies outlined in “Guidance for Industry and Food and Drug Administration Staff—FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals” reflect an effort by the FDA to acknowledge and correct a 510(k) review process that has become lengthy, confusing, and inefficient.
“The FDA presently completes approximately 91 percent of its 510(k) applications within 90 days; however delays with the remaining 10 percent have been driving the average higher,” writes Andrew Vahradian on www.healthpointcapital.com. “The new guidelines have been designed to change this occurrence, mandating that the FDA conduct preliminary acceptance reviews on applications within 15 days of receipt, therefore moving straight into determining substantial equivalence.”
The performance goals for 510(k) submissions received from FY 2013 through FY 2017 (the timeframe defined for MDUFA III) are defined in the MDUFA III Commitment Letter. Performance goals and associated changes to be implemented in MDUFA III include:
- Most 510(k)s are subject to a user fee and all 510(k) submissions will require a valid e-copy in order to initiate review.
- 510(k) submissions are subject to an acceptance review prior to being considered for substantive review as outlined in the draft guidance document, “Refuse to Accept Policy for 510(k)s.” Within 15 calendar days of receipt, the FDA will conduct an acceptance review to determine whether the submission is complete and can be accepted for substantive review. If the submission is incomplete, within 15 calendar days the FDA will notify the submitter that the submission has not been accepted and identify those items that are the basis for the refuse to accept (RTA) decision and are therefore necessary for the submission to be considered accepted. The submission will be placed on hold and the review clock will not start until the missing elements are provided.
- Once the submission has been accepted, the FDA will conduct the substantive review and communicate with the submitter through a substantive interaction within 60 calendar days of receipt of the 510(k) submission. The substantive interaction communication can be an additional information (AI) request or an e-mail stating that the FDA will continue to resolve any outstanding deficiencies via interactive review. An SE letter issued prior to the substantive interaction goal date will also qualify as a substantive interaction for purposes of meeting the MDUFA III goal.
Other key points are that 510(k) submissions are subject to a one-tier MDUFA decision goal (there are no cycle or review cycle goals for interim actions) and that performance goals ramp up from year to year instead of remaining constant as they did under MDUFA II. For 510(k)s for which the MDUFA decision is exceeded by 10 days, FDA will send a missed MDUFA decision communication to the submitter.
Time is Ticking
The FDA has given itself five years to reduce the average wait period by 17 percent, from 150 days in FY 2012 to 124 days in FY 2017. It has also established benchmarks of 135 days for 2013-2014 and 130 days for 2014-2015.
Time will tell if these new practices by the FDA will make a difference. The Pareto Principle states that roughly 80 percent of the effects come from 20 percent of the causes; in this case, 80 percent of the delays would then come from 20 percent of the applicants (which is supported by the fact that about 90 percent of 510(k) applications are approved in 90 days). Some delays are of course FDA-related, such as switching reviewers in mid-process or using reviewers who aren’t well-trained on the newest technologies; yet many delays are also related to sloppy applications that are returned because of missing information, and then not acted on quickly.
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