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What is the US FDA Compliance?
FDA (U.S. Food and Drug Administration) is responsible for the regulation of food, drugs, medical devices, and radiation-emitting products in the United States. It involves registration and documentation, pre-market reviews (such as 510(k)), quality system requirements (such as QSR/21 CFR 820), and labeling regulations.
The Purpose of FDA Compliance
Ensure the safety, effectiveness, and transparency of medical and related products, meeting the requirements for market listing and sales in the United States.
Different product categories correspond to different regulatory paths, and compliance schemes need to be determined based on product attributes.
Common Compliance Paths (Examples)
1
Classification and Path Confirmation
- Confirm product category and regulatory clauses (such as 21 CFR)
- Determine Class I/II/III and whether 510(k)/De Novo/PMA are required
- Confirm whether registration and documentation (FURLS, Owner/Operator, etc.) are required
2
Testing and Quality System
- Conduct safety/performance/bio compatibility/EMC testing (as applicable to the product)
- Establish and run QSR/21 CFR 820 quality systems (as applicable)
3
Submission and Launch
- Prepare and submit 510(k)/PMA documents, or register the product and factory
- Complete UDI/labeling and post-market monitoring requirements
Applicable Scope (Examples)
Medical Devices
Diagnostic/treatment devices, in vitro diagnostics (IVD), wearable medical devices, etc.
Radiation-Emitting Products
Laser equipment, X-rays, ultraviolet/visible light radiation, etc.
Compliance Key Points
| Item | Key Points |
|---|---|
| Timeline | Depends on the product and path: registration and documentation may take several weeks; 510(k) is commonly 3-6 months |
| Labeling | Comply with UDI/labeling and instructions for use, ensuring consistency with the product |
| Quality System | Establish and run according to 21 CFR 820/QSR (as applicable) |
Application Materials (Examples)
List of Required Materials
- Company registration and responsible party information (US agent/dealer information if needed)
- Product technical documentation: specifications, drawings, BOM, risk management and validation reports
- Test reports: safety/performance/EMC/bio compatibility (as applicable to the product)
- Labeling/instructions for use/UDI and post-market monitoring plan (as applicable)
