2008 CFR Reference Guide for Medical Devices

Back by popular demand in a new spiral bound version!

The newly updated 2008 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
• 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!

• 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
• ICH Guideline
  • E6 - Good Clinical Practices