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 Please help us maintain this list by reporting outdated or missing documents.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
| 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 |
| 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 |
| 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 |
| 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 |
Questions? Request more information from our specialists
CONTACT USRelated
-
Introduction to the UDI System in the USA
The FDA established a unique device identification system to identify medical devices through their distribution and use. It affects all medical de
read more -
Overview of ISO 11135:2014 and Medical Device Sterilization
Does your medical device require sterilization? The new ISO 11135:2014 is becoming more recognized as the international standard for the process ma
read more