Regulatory Requirements for Marketing a Medical Device

摘要

The manual describes in detail the range of regulatory requirements by FDA for marketing a device in the United States. It does not cover Good Manufacturing Practices. The Manual is intended for use in workshops sponsored by the Bureau of Medical Devices but will prove useful as a reference on establishment registration, device listing, labeling requirements, classification, premarket notification (510k), premarket approval (PMA), and other topics of significance to medical device manufacturers.