2nd Edition

Compact Regs Parts 807, 812, and 814
CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack)




ISBN 9780849322037
Published November 17, 2003 by CRC Press
222 Pages

USD $155.00

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Book Description

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.