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U.S. Department of Health and Human Services

Medical Devices

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(Withdrawn) Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device


This guidance document was withdrawn on July 17, 2012 in accordance with Section 510(n)(2)(B) of the Federal Food, Drug, and Cosmetic Act as amended by Food and Drug Administration Safety and Innovation Act.