Federal Register #FDA-2026-N-9349

FDA Requests Public Comment on Medical Device Corrections and Removals Information Collection

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is requesting public comment on its proposed information collection regarding medical device corrections and removals. - Government Buyer: - Food and Drug Administration (FDA) - Center for Devices and Radiological Health (CDRH) - OEMs and Vendors: - No specific OEMs or vendors are mentioned - Products/Services Requested: - Information collection related to reports of corrections and removals for medical devices and radiation emitting products - No part numbers or quantities specified - Unique or Notable Requirements: - Focuses on regulatory compliance under 21 CFR Part 806 - Manufacturers and importers must report certain actions and maintain records - Information is used to identify devices with serious problems and ensure removal from the market - No procurement of products or services; this is a regulatory information collection request

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to reports of corrections and removals of medical devices and radiation emitting products regulated by FDA's Center for Devices and Radiological Health (CDRH). This collection supports the implementation of provisions requiring device manufacturers and importers to report promptly to FDA certain actions concerning device corrections and removals and to maintain associated records. The information collected is used by FDA to identify marketed devices with serious problems and to ensure defective devices are removed from the market. Comments must be submitted by October 30, 2026.

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