US Medical Device Regulations
We have assembled the public documents below as a service to the medical device community. Although we do our best to ensure that these documents are the latest versions, things change. If you would like to suggest a document for inclusion or we have included an outdated version, please let us know. All documents were published by the US Food and Drug Administration and are in PDF format unless otherwise noted.
- Bar Code Label Requirements - Question and Answer
- 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
- Design Control Guidance for Medical Device Manufacturers
- Expedited Review for Medical Device Submissions
- FDA Export Certificates
- FDA User Fees
- Food, Drug and Cosmetic Act - Medical Devices
- General Principles of Software Validation
- Human Factors in Medical Device Design
- ICH Q9 Quality Risk Management
- In Vitro Diagnostic (IVD) Device Studies FAQ
- Labeling for Medical Devices
- Post Market Surveillance Guidance
- Premarket Assessment of Pediatric Medical Devices
- Premarketing Risk Assessment
- Providing Regulatory Submissions in Electronic Format - Content of Labeling
- Quality Systems Regulations (QSR)
- Use of Symbols on Labels of IVDs for Professional Use
- Validation Data for Reprocessed Single-Use Devices
