US FDA Medical Device Regulations

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.

Major regulations:

• Food, Drug and Cosmetic Act - Medical Devices
• Quality Systems Regulations (QSR) - 21 CFR Part 820

Guidance documents:

The FDA publishes hundreds of guidance documents on very specific issues. We have attempted to assemble the guidance documents we feel are most relevant to the largest number of medical device and IVD companies. For a complete listing search the FDA database of guidance documents.

FDA General Guidance:

• 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

FDA Device Specific Guidance:

• 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

Other documents of interest published by the FDA

• FDA User Fees
• Small Business Guide to FDA
• Human Factors in Medical Device Design
• CDRH FY 2010 Strategic Priorities - NEW
• FDA Draft Proposals for Public Comment Regarding Disclosure Policies of the FDA - Now closed for Public Comment

Regulatory overview:

• Emergo Group overview of the US FDA regulatory process for medical devices explained in an easy-to-understand flow chart