USA Medical Device Regulations

Major Regulations

DocumentLanguageNumberPublished
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 82009/2016

General Guidance Documents

DocumentLanguageNumberPublished
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

DocumentLanguageNumberPublished
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

DocumentLanguageNumberPublished
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