3 Sep 2025

📋FDA Announces Information Collection for Medical Device Accessories

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories

Summary

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Agencies

  • Health and Human Services Department
  • Food and Drug Administration

Business Impact ?

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The FDA's announcement regarding the collection of information on medical device accessories involves compliance and regulatory requirements for manufacturers, impacting how businesses classify and submit requests for accessories. This may increase operational responsibilities and associated costs for manufacturers.

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