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Premarket Approval (PMA) Manual

机译：上市前批准（pma）手册

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The manual details the type of information needed in a Premarket Approval (PMA)so that the Food and Drug Administration (FDA) can evaluate the safety and effectiveness of a medical device. Information in the manual is intended to aid applicants in the preparation of a PMA application as required by the Medical Device Amendments of 1976 and the PMA procedural regulation, 21 Code of Federal Regulations Parts 16 and 814. The manual incorporates both the Premarket Approval (PMA) Manual (October 1986; HHS Publication FDA 87-4214) and the Premarket Approval (PMA) Manual Supplement (August 1991; HHS Publication FDA 91-4245) and contains information on the premarket approval process such as compliance policy and guidance, procedural guidance, and guidance on developing an adequate investigational plan. The manual also addresses the changes in the PMA process required by the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.

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