FDA Asks for Feedback on Premarket Notification Forms Process
Published Date: 3/19/2026
Notice
Summary
The FDA wants your thoughts on how it collects info for device Premarket Notifications, which are needed before some medical devices hit the market. This affects companies making these devices and anyone involved in the approval process. You’ve got until May 18, 2026, to share your comments, so don’t miss out on shaping the rules and possibly saving time and money!
Analyzed Economic Effects
6 provisions identified: 2 benefits, 4 costs, 0 mixed.
Big jump in 510(k) filings
If you make medical devices that require a 510(k), the FDA now estimates 510(k) submissions rose from 100 to 3,800. That change contributes to an overall annual reporting burden of 16,295 responses and 469,183 hours, and the agency reports an increase of 145,804 hours and 3,625 responses annually.
New clinical-trial certification added
If you submit a 510(k), the information collection is being revised to include Form FDA 3674, "Certification of Compliance, Under 42 U.S.C. 282(j)(5)(B), with Requirements of ClinicalTrials.gov." Where available, that certification must include the appropriate National Clinical Trial numbers.
Custom-device annual reporting included
Manufacturers distributing custom devices under section 520(b) will be covered by the information collection: FDA lists annual reporting for custom devices at 31 respondents, 31 responses, and 40 hours per response (1,240 hours total).
eSTAR electronic templates added
The FDA will include electronic submission templates (Form FDA 4062 and FDA 4078) for eSTAR-format 510(k)s and estimates a one-time eSTAR setup burden for 80 respondents (80 responses) at 0.08 hours each (total 6 hours).
Acceptance checklist to simplify 510(k)s
FDA includes an "Acceptance Checklist" in the collection and states the checklist can be a helpful resource for 510(k) submitters and may simplify preparation of the 510(k).
60-day comment window (deadline)
FDA is requesting public comments on this information collection under the Paperwork Reduction Act; comments must be submitted electronically or by mail by May 18, 2026 (until 11:59 p.m. ET online).
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