US Medical Device Regulations published by US FDA

All documents listed below were published by the US Food and Drug Administration (FDA). Please help us maintain this list by reporting outdated or missing documents.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


Document	Language	Number	Published
Establishment Registration & Device Listing For Manufacturers & Importers Of Devices	en	21 CFR Part 807	04/2010
Food, Drug and Cosmetic Act - Medical Devices	en	Chap 5	09/2014
Labeling	en	21 CFR Part 801	04/2012
Medical Device Reporting	en	21 CFR Part 803	04/2010
Medical Device Tracking Requirements	en	21 CFR Part 821	04/2011
Medical Devices; Reports Of Corrections And Removals	en	21 CFR Part 806	04/2010
Quality Systems Regulations (QSR) 21 CFR Part 820	en	21 CFR Part 820	09/2016

General Guidance Documents


Document	Language	Number	Published
Bar Code Label Requirements - Question and Answer	en	US-001	08/2011
Certifications To Accompany Device Applications/Submissions: Compliance with Section 402(j)	en	US-002	01/2009
Computerized Systems Used in Clinical Trials	en	US-003	05/2007
Design Control Guidance for Medical Device Manufacturers	en	CFR 820.30	03/1997
Emergency Use Authorization of Medical Products	en	US-004	07/2007
Expedited Review for Medical Device Submissions	en	108	02/2008
FDA Export Certificates	en	US-005	04/2005
Good Reprint Practices - Distribution of Medical Journal Articles for Cleared Medical Devices	en	US-006	01/2009
ICH Q9 Quality Risk Management	en	US-007	06/2006
Labeling for Medical Devices	en	1128	04/2001
Post Market Surveillance Guidance	en	98D-0106	04/2006
Premarketing Risk Assessment	en	US-008	03/2005
Providing Regulatory Submissions in Electronic Format - Content of Labeling	en	US-009	04/2005

Specific Guidance Documents


Document	Language	Number	Published
Container and Closure System Integrity Testing in Lieu of Sterility Testing	en	US-010	02/2008
Content of Premarket Submissions for Software Contained in Medical Devices	en	337	05/2005
Current Good Manufacturing Practice for Combination Products	en	US-011	09/2004
Expedited Access for Premarket Approval Medical Devices	en	1400007	04/2014
General Principles of Software Validation	en	938	01/2002
Global Unique Device Identification Database - Guidance for Industry	en	1831	06/2014
In Vitro Diagnostic (IVD) Device Studies FAQ	en	1587	10/2007
Mobile Medical Applications Guidance for Industry	en	1741	02/2015
Premarket Assessment of Pediatric Medical Devices	en	1220	05/2004
Unique Device Identification System - FDA Final Rule	en	2013-23059	09/2013
Use of Symbols on Labels of IVDs for Professional Use	en	4444	11/2004
Validation Data for Reprocessed Single-Use Devices	en	1216	09/2006

Additional Information


Document	Language	Number	Published
Human Factors in Medical Device Design	en	1757	06/2011
Small Business Guide to FDA	en	US-014	09/ 2011
US FDA Transparency Initiative: Improving Transparency To Regulated Industry - Phase III Report	en	US-015	01/2011

USA Medical Device Regulations

US FDA Code of Federal Regulations

Major Regulations

General Guidance Documents

Specific Guidance Documents

Additional Information