Opportunity
Federal Register #FDA-2004-N-0451
FDA Updates Recognized Standards for Medical Devices (Recognition List Number: 066)
Buyer
Food and Drug Administration
Posted
August 24, 2026
Respond By
August 25, 2026
Identifier
FDA-2004-N-0451
The Food and Drug Administration (FDA), under the Department of Health and Human Services, is announcing updates to its recognized standards for medical devices. - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - OEMs and Standards Organizations: - ISO (International Organization for Standardization) - IEC (International Electrotechnical Commission) - ASTM (American Society for Testing and Materials) - IEEE (Institute of Electrical and Electronics Engineers) - ANSI/ADA (American National Standards Institute/American Dental Association) - Products/Services Requested: - No specific products or services are being procured - The notice modifies the list of consensus standards recognized for medical device submissions - Standards cover categories such as anesthesiology, biocompatibility, cardiovascular, dental, quality systems, electrical safety, materials, neurology, physical medicine, radiology, software/informatics, and tissue engineering - Unique/Notable Requirements: - The update includes additions, withdrawals, corrections, and revisions to recognized standards - Manufacturers are expected to declare conformity to these updated standards in their FDA device submissions - The notice is informational and regulatory, not a procurement opportunity - Recognition List Number: 066 - Public comment is invited on the modifications
Description
The Food and Drug Administration (FDA) announces modifications to the list of standards it recognizes for use in premarket reviews of medical devices. These modifications include additions, withdrawals, corrections, and revisions to consensus standards to assist manufacturers in declaring conformity with these standards. The changes are effective August 24, 2026, and comments on the notice can be submitted electronically or in writing at any time. The publication provides detailed updates to recognized standards across various medical device categories.