When planning around FDA 510(k) clearance timelines, it's crucial to remember FDA's agency performance goals mandated by law (e.g., the Medical Device User Fee Amendments of 2017, a.k.a., "MDUFA IV"). Specifically, MDUFA IV generally requires that for 95% of 510(k)s, FDA is to render a final decision within 90 "FDA days". An "FDA day" is basically any calendar day where FDA is engaged in active review of the 510(k). This concept is important, because if FDA issues a substantive AIR (Additional Information Request), then FDA stops the 90-day clock (putting the submission on "hold") until the Sponsor submits a complete/substantive response enabling FDA to resume its review. A Sponsor is generally given 180 calendar days to submit its response to an AIR. Note that FDA also has a further performance goal to achieve an average total time to decision of 116 calendar days for FY2020. "Total time to decision" is the number of calendar days from the date of receipt of a filed submission to a MDUFA decision.
Accordingly, and technically speaking, there is a 5% chance that FDA might miss the 90-FDA-day timeline. But if the Sponsor has properly addressed all outstanding AIRs, and if FDA truly doesn't have further questions, then we can expect FDA to issue its final decision within the 90 FDA days, as the 5% margin is generally intended for accommodation of unusual submission circumstances.
For at least the prior three years (FY2017-2019), FDA met the 510(k)-decision performance goal 99% of the time (meaning they successfully met the overall 95% performance goal).
FDA's MDUFA Performance Reports through FY2019 can be accessed here. FDA appears to be maintaining the 99% performance rate thus far for FY2020 based on the
running 2020 performance data available here.
My experience has been that FDA may, but doesn't generally, work on weekends. But since "FDA days" are
calendar days (thus including weekdays and weekends), it is always possible that FDA would issue a clearance letter on a weekend in order to meet a MDUFA performance goal. I don't recall any of my prior 510(k) clearances being dated on a weekend, but perhaps others in the Forum can lend their experiences on that.
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 11-Nov-2020 21:05
From: Anonymous Member
Subject: Clearance letter by day 90
This message was posted by a user wishing to remain anonymous
Dear RAPS members,
I would like to understand the FDA timeline for providing a clearance letter to the submitter. If all interactive review questions were answered (including the 510(k) summary revision) and no additional questions were asked, is it possible that the clearance letter is provided on day 90, and can they miss the 90 day timeline even if they don't have any additional questions? Do they provide the clearance letters on weekends?
Thanks in advance