FDA Tunes Up Medical Device Advice Forms
Published Date: 2/18/2026
Notice
Summary
The FDA wants your thoughts on how they collect info for their Q-Submission and Early Payor Feedback programs, which help medical device makers get advice early on. These updates aim to make the process smoother for companies working with the FDA, saving time and possibly money. If you’re involved in medical device development, speak up by March 20, 2026, to help shape these important tools!
Analyzed Economic Effects
5 provisions identified: 3 benefits, 2 costs, 0 mixed.
Large Paperwork Hour Increase
If you make or sponsor medical devices, FDA estimates the information collection will total 864,418 hours annually and reports an overall increase of 451,180 hours and 4,535 responses per year. The agency requests comments by March 20, 2026.
eSTAR Voluntary Electronic Submission Option
FDA has an electronic Submission Template and Resource (eSTAR) for Q-Submissions that is currently voluntary. Q-Submissions using eSTAR are shown with an average burden of 69 hours per response and an eSTAR setup burden of 0.08 hours (5 minutes) per respondent.
MDDT Submissions Tracked Separately
Medical Device Development Tool (MDDT) submissions are now tracked as a distinct collection instrument under the MDDT guidance; FDA estimates 50 MDDT submissions annually with an average burden of 137 hours each (6,850 hours total). FDA states the submission instructions are otherwise unchanged and that there is no new collection occurring in this revision.
Early Payor Feedback Form Burden
Manufacturers may request payor organizations join Pre-Submission meetings through the Early Payor Feedback Program using a voluntary form. FDA estimates the manufacturer request form takes 2 hours per response and estimates 35 such responses annually (70 hours total).
No Capital or O&M Costs Reported
FDA states there are no capital costs or operating and maintenance costs associated with this information collection. The burden estimates reflect only respondent time.
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