USA Medical Device Regulations

All documents listed below were published by the US Food and Drug Administration (FDA) and are in PDF format. Please help us maintain this list by reporting outdated or missing documents. If you need help determining the regulatory requirements for your medical device in the United States, you may be interested in our custom regulatory strategy reports for the United States.

US FDA Code of Federal Regulations

Major Regulations

Establishment Registration & Device Listing For Manufacturers & Importers Of Devices en 21 CFR Part 80704/2010
Food, Drug and Cosmetic Act - Medical Devicesen Chap 509/2014
Labeling en 21 CFR Part 80104/2012
Medical Device Reportingen 21 CFR Part 80304/2010
Medical Device Tracking Requirements en 21 CFR Part 82104/2011
Medical Devices; Reports Of Corrections And Removalsen 21 CFR Part 80604/2010
Quality Systems Regulations (QSR) 21 CFR Part 820en 21 CFR Part 82006/2016

General Guidance Documents

Bar Code Label Requirements - Question and Answeren US-00108/2011
Certifications To Accompany Device Applications/Submissions: Compliance with Section 402(j)en US-00201/2009
Computerized Systems Used in Clinical Trialsen US-00305/2007
Design Control Guidance for Medical Device Manufacturersen CFR 820.3003/1997
Emergency Use Authorization of Medical Productsen US-00407/2007
Expedited Review for Medical Device Submissionsen 10802/2008
FDA Export Certificatesen US-00504/2005
Good Reprint Practices - Distribution of Medical Journal Articles for Cleared Medical Devicesen US-00601/2009
ICH Q9 Quality Risk Managementen US-00706/2006
Labeling for Medical Devicesen 1128 04/2001
Post Market Surveillance Guidanceen 98D-010604/2006
Premarketing Risk Assessmenten US-00803/2005
Providing Regulatory Submissions in Electronic Format - Content of Labelingen US-00904/2005

Specific Guidance Documents

Container and Closure System Integrity Testing in Lieu of Sterility Testingen US-01002/2008
Content of Premarket Submissions for Software Contained in Medical Devicesen 33705/2005
Current Good Manufacturing Practice for Combination Productsen US-01109/2004
Expedited Access for Premarket Approval Medical Devicesen 140000704/2014
General Principles of Software Validationen 938 01/2002
Global Unique Device Identification Database - Guidance for Industryen 183106/2014
In Vitro Diagnostic (IVD) Device Studies FAQen 158710/2007
Mobile Medical Applications Guidance for Industryen 174102/2015
Premarket Assessment of Pediatric Medical Devicesen 122005/2004
Unique Device Identification System - FDA Final Ruleen 2013-23059 09/2013
Use of Symbols on Labels of IVDs for Professional Useen 444411/2004
Validation Data for Reprocessed Single-Use Devicesen 121609/2006

Additional Information

CDRH FY 2010 Strategic Prioritiesen US-0122010
FDA User Fees - Fiscal Year 2014en US-01308/2013
Human Factors in Medical Device Designen 175706/2011
Small Business Guide to FDAen US-01409/ 2011
US FDA Transparency Initiative: Improving Transparency To Regulated Industry - Phase III Reporten US-01501/2011