Federal Register #FDA-2026-N-2915

FDA Requests Public Comment on Premarket Approval Information Collection for Medical Devices

This notice from the Food and Drug Administration (FDA) seeks public comment on proposed information collection requirements for the premarket approval (PMA) process for Class III medical devices. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Scope of Request: - Collection of information related to PMA applications, amendments, supplements, postapproval reports, and pediatric use information for high-risk (Class III) medical devices - Includes certifications for clinical trials and use of electronic submission tools (e.g., eSTAR) - No OEMs or vendors are specified, as this is a regulatory information collection notice, not a procurement of products or services - Unique Requirements: - Focus on regulatory submissions and compliance for medical device manufacturers - FDA is seeking feedback on the necessity, accuracy, and burden of these information collection requirements - No products or services are being purchased; this is a request for public input on regulatory processes

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to the premarket approval (PMA) of medical devices. This process involves scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, which are high-risk devices requiring FDA approval before marketing. The notice outlines the information collection requirements, including submissions, amendments, supplements, and postapproval reports, as well as pediatric use information and certifications related to clinical trials. The FDA invites comments on the necessity, accuracy, and burden of this information collection, with a comment period ending June 9, 2026.

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