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FDA Issues New Draft Guidance on De Novo Classification Process

21 October 2011

Medical Device Alert

On Monday, 3 October 2011, the Food and Drug Administration's (FDA or "the Agency") Center for Devices and Radiological Health (CDRH) issued a draft guidance regarding the submission and review of petitions under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), also known as the de novo classification process.



Read "FDA Issues New Draft Guidance on De Novo Classification Process

The team

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