FDA Seeks Comments on Medical Device Paperwork
Published Date: 7/6/2026
Notice
Summary
The FDA is asking for public feedback on their paperwork rules for approving the most important and risky medical devices, like life-support machines. This review helps keep devices safe and effective before they hit the market. If you have thoughts, you’ve got until August 5, 2026, to share them—no cost changes, just a check-in on the info they collect.
Analyzed Economic Effects
3 provisions identified: 0 benefits, 2 costs, 1 mixed.
Big Increase in PMA Paperwork Burden
If you are a Premarket Approval (PMA) applicant or holder of Class III medical devices, the FDA estimates total annual reporting burden of 1,182,316 hours and recordkeeping burden of 29,240 hours. The agency says this represents an overall reporting increase of about 244% and a recordkeeping increase of about 212% compared with prior estimates.
New Pediatric and Clinical Trial Reporting
FDA is adding burden for reporting pediatric-use information under section 515A and for certifications under 42 U.S.C. 282(j)(5)(B) using Form FDA 3674. The estimate in the notice shows pediatric-related reporting at 8,306 total hours annually and Form FDA 3674 certification at 46 total hours annually.
Shift to eSTAR Electronic Submissions
FDA is promoting eSTAR electronic submission templates and expects them to reduce submission burden, but also estimates initial eSTAR setup effort. The notice lists eSTAR setup at a total of 734 hours annually and describes eSTAR as a tool to 'significantly reduce burden' by providing a uniform electronic format.
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Key Dates
Department and Agencies
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