United States Medical Device Regulations

Major regulations:

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

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
• FDA Draft Proposals for Public Comment Regarding Disclosure Policies of the FDA

Regulatory overview:

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