FDA Reviews Paperwork for Products That Combine Drugs and Devices
Published Date: 10/23/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about which products they regulate, especially combo products like drug-device mixes. This helps them keep rules clear and up to date. If you’re a company or person involved with these products, speak up by December 22, 2026—no cost changes yet, just a chance to shape the process!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Estimated Time Burden for Sponsors
FDA estimates 149 sponsors respond annually, with a total annual burden of 3,579 hours. That includes 52 Requests for Designation (RFDs) at 24 hours each (1,248 hours), 94 Pre-RFDs at 24 hours each (2,256 hours), and 3 Combination Product Agreement Meetings (CPAM) requests at 25 hours each (75 hours); FDA reports an overall increase of 336 hours and 14 responses compared with prior estimates.
Opportunity to Comment — Deadline Dec 22, 2026
If you make or sponsor medical products (including combination products), the FDA is asking for public comments on its proposed information collection rules about product jurisdiction and combination products. You can submit comments electronically or by mail by December 22, 2026.
No Capital or Ongoing Cost Claimed
FDA states there are no capital costs or operating and maintenance costs associated with this information collection. The Agency treats the burden as time (hours) only, not direct equipment or maintenance expenses.
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Key Dates
Department and Agencies
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