FDA

FDA www.fda.gov

Medical Devices http://www.fda.gov/MedicalDevices/default.htm

CFR - Code of Federal Regulations Title 21

Quality System (QS) Regulation / Medical Device Good Manufacturing Practices

Medical Device Quality System Manual - A Small Entity Compliance Guide

• Supercedes the Medical Devices Good Manufacturing [GMP] Practices Manual

FDA Inspection Guides http://www.fda.gov/ICECI/Inspections/InspectionGuides/default.htm

• Quality Systems http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074883.htm
• Medical Device Manufacturers http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

Forum on 21 CFR Part 11

• http://www.21cfrpart11.com/pages/faq/index.htm