USA Medical Device Regulations

USA

We have assembled the following documents as a service to the medical device community. All documents were published by the US Food and Drug Administration (FDA) and are in PDF format. Help us keep these files up to date. If you find a newer version of a document or one that should be included, please email us.

Quality Systems Regulation

• US FDA Quality System Regulation – 21 CFR Part 820 (Interactive Web page. Or download .pdf document of 21 CFR Part 820.)

Major Regulations

• Food, Drug and Cosmetic Act - Medical Devices
• Labeling - 21 CFR Part 801
• Medical Device Reporting - 21 CFR Part 803
• Medical Devices; Reports Of Corrections And Removals - 21 CFR Part 806
• Establishment Registration & Device Listing For Manufacturers & Importers Of Devices - 21 CFR Part 807
• Quality Systems Regulations (QSR) - 21 CFR Part 820
• Medical Device Tracking Requirements - 21 CFR Part 821

General Guidance Documents

• Bar Code Label Requirements - Question and Answer
• Certifications To Accompany Device Applications/Submissions: Compliance with Section 402(j)
• Computerized Systems Used in Clinical Trials
• Design Control Guidance for Medical Device Manufacturers
• Emergency Use Authorization of Medical Products
• Expedited Review for Medical Device Submissions
• FDA Export Certificates
• Good Reprint Practices - Distribution of Medical Journal Articles for Cleared Medical Devices
• ICH Q9 Quality Risk Management
• Labeling for Medical Devices
• Post Market Surveillance Guidance
• Premarketing Risk Assessment
• Providing Regulatory Submissions in Electronic Format - Content of Labeling

Specific Guidance Documents

• Container and Closure System Integrity Testing in Lieu of Sterility Testing
• Content of Premarket Submissions for Software Contained in Medical Devices
• Current Good Manufacturing Practice for Combination Products
• General Principles of Software Validation
• Premarket Assessment of Pediatric Medical Devices
• Use of Symbols on Labels of IVDs for Professional Use
• Validation Data for Reprocessed Single-Use Devices
• In Vitro Diagnostic (IVD) Device Studies FAQ

Additional Information

• FDA User Fees
• Small Business Guide to FDA
• Human Factors in Medical Device Design
• CDRH FY 2010 Strategic Priorities
• US FDA Transparency Initiative: Draft Proposals