Compact Regs Parts 807, 812, and 814: CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack), 2nd Edition (Paperback) book cover

Compact Regs Parts 807, 812, and 814

CFR 21 Parts 807, 812, and 814 Medical Device Approval (10 Pack), 2nd Edition

Edited by Interpharm

CRC Press

224 pages

Purchasing Options:$ = USD
Paperback: 9780849322037
pub: 2003-11-17
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Hardback: 9781138407282
pub: 2018-09-27
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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.

Subject Categories

BISAC Subject Codes/Headings:
TEC021000
TECHNOLOGY & ENGINEERING / Material Science
TEC059000
TECHNOLOGY & ENGINEERING / Biomedical