FDA Seeks OMB Nod for Device Accessory Info Gathering
Published Date: 9/3/2025
Notice
Summary
The FDA wants to collect info about medical device accessories and has asked the Office of Management and Budget to review this plan. This affects companies making or selling these accessories, who might need to share more details soon. The goal is to keep things safe without causing extra hassle or costs, and the review is happening now to keep everything on track.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
FDA Seeks OMB Clearance for Accessory Data
If you make or sell medical device accessories, you may need to provide additional information soon because the FDA submitted a proposed collection of information to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995. The agency says the goal is to keep accessories safe while avoiding extra hassle or costs for companies.
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