FDA Asks for Input on Device Approval Paperwork
Published Date: 4/10/2026
Notice
Summary
The FDA wants your thoughts on how it collects info for approving new medical devices before they hit the market. This affects device makers who must provide detailed info to prove their products are safe and effective. You’ve got until June 9, 2026, to share your comments, helping shape a smoother, clearer approval process without extra costs or delays.
Analyzed Economic Effects
5 provisions identified: 0 benefits, 4 costs, 1 mixed.
Large Increase in PMA Compliance Hours
If you make Class III medical devices and submit Premarket Approval (PMA) applications, FDA estimates total annual burden for this information collection at 1,182,316 hours. FDA says the overall reporting burden estimate rose by about 244%, driven by more frequent submissions like PMA amendments and 30-day notices.
Pediatric Use Info Must Be Submitted
PMA applicants must provide pediatric-use information under section 515A of the FD&C Act, including a description of pediatric subpopulations and the number of affected pediatric patients. FDA included pediatric information burden in its estimate (pediatric items total 8,306 hours annually).
Recordkeeping Burden for PMA Holders Increased
Applicants with approved PMAs must maintain records used to trace patients and ensure continued safety; FDA estimates 860 active PMAs with recordkeeping averaging 17 hours per recordkeeper for a total of 29,240 hours annually. FDA reports recordkeeping burden rose about 212%.
ClinicalTrials.gov Certification Required (Form FDA 3674)
Certain PMA applications must be accompanied by a certification under 42 U.S.C. 282(j)(5)(B) using Form FDA 3674, and should include National Clinical Trial numbers where available. FDA estimates the annual burden for these certifications at 46 hours total.
Electronic eSTAR Submissions — Setup and Savings
FDA encourages use of the eSTAR electronic submission template. FDA says eSTAR should significantly reduce submission burden, but it included initial eSTAR setup burden in its estimate (9,174 setup submissions at 0.08 hours each, totaling 734 hours annually).
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