GMP Publications - Code of Federal Regulation Handbooks by the FDA

In Vitro Diagnostics Master Handbook

InvitroMaster.jpg
978-1-935131-59-5

Over 300 pages of US/EU Regulations and Guidance!

US FDA Title 21 CFR Parts

Part 11 -- Electronic Records, Electronic Signatures
Part 50 -- Protection of Human Subjects
Part 803 -Medical Device Reporting
Part 806 -- Medical Devices; Reports of Corrections and Removals
Part 809 -- In Vitro Diagnostic Products for Human Use
Part 820 -- Quality Systems Regulations

In Vitro Diagnostics 98/79/EC Medical Devices

Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions - June 25, 2010

In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions - HHS Publication FDA 97-4224











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