Please find below a list of important documents published by the US Food and Drug Administration (FDA), which will help you better understand FDA medical device regulations.
ISOplan USA can assist your company in evaluating FDA regulations as they apply to your medical device or IVD.
Many medical device companies must also meet quality system requirements laid out in 21 CFR Part 820 in order to commercialize their products in the US.
FDA Quality System Regulation:
Major FDA Medical Device Regulations:
- Food, Drug and Cosmetic Act – Medical Devices
- FDA Establishment Registration & Device Listing – 21 CFR Part 807
- FDA Medical Device Reporting – 21 CFR Part 803
- FDA Labeling – 21 CFR Part 801
- FDA Medical Devices Reports Of Corrections And Removals – 21 CFR Part 806
- FDA Medical Device Tracking Requirements – 21 CFR Part 821
General FDA Guidance Documents for Medical Devices:
- FDA Device Design Control Guidelines for Medical Devices
- FDA Guidance for Industry Computerized Systems Used in Clinical Investigations
- FDA Expedited Review for Medical Device Submissions
- FDA Export Certificates
- FDA ICH Q9 Quality Risk Management
- FDA Medical Device Labeling
- FDA Premarketing Risk Assessment
- Regulatory Submissions in Electronic Format
Specific FDA Guidance Documents for Medical Devices:
- FDA General Principles of Software Validation
- Content of Premarket Submissions for Software Contained in Medical Devices
- FDA Container and Closure System Integrity Testing in Lieu of Sterility Testing
- FDA Current Good Manufacturing Practice for Combination Products
- In Vitro Diagnostic (IVD) Device Studies FAQ
- FDA Use of Symbols on Labels of IVD’s for Professional Use
- FDA Premarket Assessment of Pediatric Medical Devices
- FDA Validation Data for Reprocessed Single-Use Medical Devices
General Information:
- FDA Small Business Guide
- FDA CDRH 2010 Strategic Priorities
- FDA Human Factors in Medical Device Design