FDA Wants Your Thoughts on Medical Device Paperwork—Again
Published Date: 2/26/2026
Notice
Summary
The FDA is asking for public feedback on their plan to keep collecting info about investigational medical devices—those being tested for safety and effectiveness. This affects companies and researchers working on new medical devices, with no new costs or big changes, just a routine paperwork update. Comments are open until March 30, 2026, so now’s the time to speak up!
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Overall Paperwork Burden Increased
FDA estimates the total annual paperwork burden for investigational device exemptions increased by 9,919 hours and by 1,033 responses. The agency reports totals of 6,552 annual reporting responses (63,828 hours) and 6,059 recordkeeping records (11,994 hours), reflecting the higher workload for companies and researchers who submit IDE materials.
IDE Application Preparation Time
For investigational device exemption applications and investigational plans (21 CFR 812.20, 812.25, and 812.27), FDA estimates 288 responses annually with an average burden of 80 hours per response, totaling 23,040 hours each year. Other activity-level estimates include items such as 1,500 submissions accepting foreign clinical data averaging 10.25 hours each (15,375 hours).
Use of Leftover Specimens Without Consent
FDA’s guidance (GFI IVD Leftover Specimens April 2006) states the agency does not intend to object to use of leftover human specimens without informed consent if the specimens are not individually identifiable and the study meets the exemption criteria in 21 CFR 812.2(c)(3). This allows investigators to use remnants of specimens collected for routine clinical care in certain IDE studies while protecting subject privacy.
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Key Dates
Department and Agencies
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