In Vitro Diagnostics Master Handbook

Over 500 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 2017/746 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