Federal Register #FDA-2023-D-2370

FDA Guidance on Patient-Matched Orthopedic Implant Guides and MICARDIS Regulatory Status

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, announces the release of a final guidance document and regulatory determination: - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Guidance Document: - "Patient-Matched Guides for Orthopedic Implants" provides recommendations for manufacturers on regulatory submissions and design processes for patient-matched orthopedic implant guides - Aims to clarify submission expectations, improve review efficiency, and promote transparency for industry and FDA staff - Regulatory Determination: - FDA determined that MICARDIS (telmisartan) tablets, 20 mg and 80 mg (NDA 020850), were not withdrawn from sale for safety or effectiveness reasons - Allows continued approval of generic versions - Products/Services: - No procurement of products or services is requested in this notice - No specific OEMs or vendors are named - Unique/Notable Requirements: - The guidance is intended to inform industry and FDA staff about regulatory requirements and processes related to orthopedic patient-matched guides - Includes recommendations for regulatory submissions and best practices for design - Locations: - FDA Headquarters and Dockets Management Staff offices in Silver Spring and Rockville, Maryland

Description

The Food and Drug Administration (FDA) announces the availability of a final guidance titled "Patient-Matched Guides for Orthopedic Implants." This guidance provides recommendations on the information to include in regulatory submissions for patient-matched guides for orthopedic implants and offers design process considerations for manufacturers. It aims to promote clarity and transparency regarding submission expectations and may improve efficiency and consistency in the review process.

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