Premarket Notification 510(k): Regulatory Requirements for Medical Devices (Revised).

摘要

The publication covers premarket notification procedures under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. Persons intending to market a new or significantly modified device are required to submit a premarket notification to FDA in order to establish substantial equivalence to a legally marketed device. This manual reflects changes resulting from the passage of the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.