Newly Updated November 5, 2009!
Back by popular demand in a spiral bound version!
The newly updated 2009 CFR Reference Guide for Medical Devices contains the FDA Code of Federal Regulations:
- Good Clinical Practice Parts 11, 50, 54, and 56
- Medical Devices and Quality Systems Parts 801, 803, 806, 807, 812, 814, 820, and 822
- Product Jurisdiction Part 3 for Combination Products
- Plus - ICH Guideline Good Clinical Practice (E6)
The pocket reference guide is ideal for new hire packets, giveaways, IRBs, regulatory personnel, QA/QC departments, institutions, site and management organizations, CRAs, sponsors, investigator meetings, research facilities, universities, hospitals and more! Plus, the guides may be customized with your company logo for orders of 100+ books.
For bulk and/or custom cover orders, please call toll-free 1-800-856-2556.
Table of Contents
CFR Title 21: Food and Drugs
Title 21, Part 11 - Electronic Records, Electronic Signatures.
Title 21, Part 50 - Protection of Human Subjects
Title 21, Part 54 - Financial Disclosure by Clinical Investigators
Title 21, Part 56 - Institutional Review Boards
Title 21, Part 801 -Labeling
Title 21, Part 803 -Medical Device Reporting
Title 21, Part 806 -Medical Devices; Reports of Corrections and Removals
Title 21, Part 807 -Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Title 21, Part 812 -Investigational Device Exemptions
Title 21, Part 814 -Premarket Approval of Medical Devices
Title 21, Part 820 -Quality System Regulation
Title 21, Part 822 -Postmarket Surveillance
Title 21, Part 3 - Product Jurisdiction
E6 - Good Clinical Practices