USA Medical Device Regulations
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 Please help us maintain this list by reporting outdated or missing documents.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
- 21 CFR Part 11 - Electronic Records; Electronic Signatures
- 21 CFR Part 801 - Labeling
- 21 CFR Part 803 - Medical Device Reporting Or download PDF.
- 21 CFR Part 806 - Reports Of Corrections And Removal. Or download PDF
- 21 CFR Part 807 - Establishment Registration. Or download PDF
- 21 CFR Part 809 - In Vitro Diagnostic Products For Human Use
- 21 CFR Part 812 - Investigational Device Exemptions
- 21 CFR Part 820 - Quality System Regulation. Or download PDF.
- 21 CFR Part 821 - Medical Device Tracking Requirements. Or download PDF.
- 21 CFR Part 822 - Postmarket Surveillance
- 21 CFR Part 860 - Medical Device Classification Procedures
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 |