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Selected FDA regulations, guidance documents and articles

Selected references from FDA are listed below. These are available from FDA.gov or you can click on a document below to download a PDF version.

Regulations

• 21 CFR 820, Current GMP, Final Rule, October 7, 1996 FDA.
• 21 CFR Part 11, Electronic Records Electronic Signatures, Final Rule, March 20, 1997 FDA.
• EU Medical Device Regulation, May 2017
• EU In-vitro Diagnostic Regulation, May 2017

Guidance Documents

• Guidance for the Content of Premarket Submission for Software Contained in Medical Devices, May 11, 2005
• General Principles of Software Validation, Jan 2002
• Guidance for Off-the-Shelf Software Use in Medical Devices, Draft Guidance, Sept 2019
• Guidance for Content of Premarket Submissions for Management of Cybersecurity, Oct 2014
• Guidance for Postmarket Management of Cybersecurity, Dec 2016
• Guidance on When to Submit 510(k) for Changes to Software, Oct 2017
• Guidance for Multiple Function Device Products, Apr 2018

Articles

• "Networked Medical Devices: Essential Collaboration for Improved Safety", by Steven R. Rakitin, AAMI BI&T, Vol. 43, No. 4, July-Aug 2009, p.332-338.
• "Coping with Defective Software in Medical Devices", by Steven R. Rakitin, IEEE Computer, April 2006.
• "An Investigation of the Therac-25 Accidents", by Nancy Leveson and Clark Turner, IEEE Computer, July 1993.