Federal Register #FDA-2026-N-9350

FDA Requests Public Comment on Medical Device Tracking Information Collection

This opportunity involves a request for public comment by the Food and Drug Administration (FDA) regarding proposed information collection for medical device tracking. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs and Vendors: - No specific OEMs or vendors are named in this notice - Products/Services Requested: - No products or services are being procured - The notice targets manufacturers, importers, and distributors of certain class II or III medical devices - Devices affected include those: - Implanted for more than one year - Life-sustaining and used outside a device user facility - Whose failure could have serious health consequences - Unique or Notable Requirements: - The information collection supports regulatory compliance under 21 CFR Part 821 - Requirements include device tracking, patient identification, recall facilitation, and timely risk notification - Estimated 22,000 potential respondents - Covers exemptions, system requirements, distributor obligations, records/inspection, confidentiality, and record retention - No procurement or contract opportunity is present; this is a regulatory information gathering notice

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to the tracking of medical devices. This collection is required under the Paperwork Reduction Act and aims to facilitate the identification and tracking of certain class II or III medical devices that meet specific criteria, such as being implanted for more than one year or being life-sustaining. The information collected will help expedite recalls and timely notifications regarding device risks. Comments on this proposed collection must be submitted by November 10, 2026.

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