GMP Publications, Inc.

Food & Drug Administration (FDA)
US FDA Code of Federal Regulations & EU ICH Handbooks

Medical Device Combination - Standard
1-933734-58-2

Good Clinical Practices (GCP) Regulations for Medical Devices

21 CFR and ICH Parts:

11 - Electronic Records; Electronic Signatures
50 - Protection of Human Subjects
54 - Financial Disclosure by Clinical Investigators
56 - Institutional Review Boards
807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
812 - Investigational Device Exemptions
814 - Premarket Approval of Medical Devices
820 - Quality Systems Regulations
The 510k & Premarket Approval (PMA) Guidance Document

Quantity	1 - 99	100 - 249	250 - 499	500 - 999	1000+
Price	$9.90	$9.80	$9.70	$8.90	$7.90

Quantity

Medical Device QSIT Manual with Parts 11, 803, 806, 820 & 821
$9.90
978-1-935131-10-6
Medical Device QSIT Manual includes 21 CFR Parts 11, 803, 806, 820, 821, & QSIT Manual.

Part 820 US and Chinese Combination
$5.95
1-933734-78-7

Basic Medical Device QSIT with 820
$6.90
978-1-935131-17-5
Medical Device QSIT Manual includes 21 CFR Part 820 QSR