Draft Guidance Covers UDI Mandates for Combination Products

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Draft Guidance Offers Recommendations for Complying With UDI Requirements for Combination Products

Dennis Tosh

July 9, 2025 at 02:00 PM EST

Newly released draft guidance from the FDA provides proposed recommendations for manufacturers of combination products on how to comply with the agency’s unique device identifier (UDI) requirements, which may be triggered when a combination product includes a medical device component. The draft guidance, “Unique Device Identifier (UDI) Requirements for Combination Products,” ... Read More

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Draft Guidance Offers Recommendations for Complying With UDI Requirements for Combination Products

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