Buch, Englisch, 222 Seiten, Format (B × H): 140 mm x 140 mm, Gewicht: 1461 g
Buch, Englisch, 222 Seiten, Format (B × H): 140 mm x 140 mm, Gewicht: 1461 g
ISBN: 978-0-8493-2203-7
Verlag: CRC Press
Supplemented with a convenient keyword index, this book provides a pocket-sized verbatim reproduction of key US FDA regulations. It presents the requirements as set forth by the FDA CFR 21 Parts 807, 812, and 814 to sell or distribute medical devices, including the pre-market approval requirements for the devices. The easy-to-use format that puts the exact section of the reg required by medical device manufacturers within easy reach. This is the perfect low-cost tool for employees as part of documented training programs; suppliers/vendors so that they may provide components, labels, and parts with an understanding of FDA requirements; and technicians charged with ensuring adherence to US FDA regulations.
Zielgruppe
Professional
Autoren/Hrsg.
Weitere Infos & Material
21 CFR Part 807 Establishment Registration and Device Listing for Manufacturing and Initial Importers of Devices 21 CFR Part 812 Investigational Device Exemptions 21 CFR Part 814 Premarket Approval of Medical Devices PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES Subpart A—General Provisions Sec. 807.3 Definitions. Subpart B—Procedures for Device Establishments; Subpart C—Registration Procedures for Foreign Device Establishments Subpart D—Exemptions Subpart E—Premarket Notification Procedures
