USA Medical Device Regulations

Major Regulations
Document Number Published Language
Download Quality Systems Regulations (QSR) 21 CFR Part 820 21 CFR Part 820 09/2016 English
Download Food, Drug and Cosmetic Act - Medical Devices Chap 5 English
Download Medical Device Tracking Requirements 21 CFR Part 821 04/2011 English
Download Establishment Registration & Device Listing For Manufacturers & Importers Of Devices 21 CFR Part 807 04/2010 English
Download Medical Device Reporting 21 CFR Part 803 04/2010 English
Download Labeling 21 CFR Part 801 04/2012 English
Download Medical Devices; Reports Of Corrections And Removals 21 CFR Part 806 04/2010 English
General Guidance Documents
Document Number Published Language
Download Providing Regulatory Submissions in Electronic Format - Content of Labeling US-009 04/2005 English
Download Premarketing Risk Assessment US-008 03/2005 English
Download ICH Q9 Quality Risk Management US-007 06/2006 English
Download Good Reprint Practices - Distribution of Medical Journal Articles for Cleared Medical Devices US-006 01/2009 English
Download FDA Export Certificates US-005 04/2005 English
Download Emergency Use Authorization of Medical Products US-004 07/2007 English
Download Computerized Systems Used in Clinical Trials US-003 05/2007 English
Download Certifications To Accompany Device Applications/Submissions: Compliance with Section 402(j) US-002 01/2009 English
Download Bar Code Label Requirements - Question and Answer US-001 08/2011 English
Download Post Market Surveillance Guidance 98D-0106 04/2006 English
Download Labeling for Medical Devices 1128 04/2001 English
Download Expedited Review for Medical Device Submissions 108 02/2008 English
Download Design Control Guidance for Medical Device Manufacturers CFR 820.30 03/1997 English
Specific Guidance Documents
Document Number Published Language
Download Mobile Medical Applications Guidance for Industry 1741 02/2015 English
Download Current Good Manufacturing Practice for Combination Products US-011 09/2004 English
Download Container and Closure System Integrity Testing in Lieu of Sterility Testing US-010 02/2008 English
Download Global Unique Device Identification Database - Guidance for Industry 1831 06/2014 English
Download Unique Device Identification System - FDA Final Rule 2013-23059 09/2013 English
Download In Vitro Diagnostic (IVD) Device Studies FAQ 1587 10/2007 English
Download Validation Data for Reprocessed Single-Use Devices 1216 09/2006 English
Download Use of Symbols on Labels of IVDs for Professional Use 4444 11/2004 English
Download Premarket Assessment of Pediatric Medical Devices 1220 05/2004 English
Download General Principles of Software Validation 938 01/2002 English
Download Content of Premarket Submissions for Software Contained in Medical Devices 337 05/2005 English
Download Expedited Access for Premarket Approval Medical Devices 1400007 04/2014 English
Additional Information
Document Number Published Language
Download US FDA Transparency Initiative: Improving Transparency To Regulated Industry - Phase III Report US-015 01/2011 English
Download Small Business Guide to FDA US-014 09/ 2011 English
Download Human Factors in Medical Device Design 1757 06/2011 English