Quick Answer
FDA compliance applies to food, drugs, medical devices, cosmetics, and food-contact materials entering the US. Depending on the product, it can require facility registration, product listing, clearance or approval (such as 510(k) for devices), labelling requirements, and testing. Registration is an obligation, not FDA endorsement.
What FDA Compliance Can Require
- Facility registration with the FDA
- Product listing and, for devices, 510(k) clearance or approval
- Compliance with US labelling and content requirements
- Testing to demonstrate safety or performance
Requirements differ sharply by product category. Confirm exactly what applies to your product, and verify supplier claims in the FDA databases rather than trusting certificates. See verifying FDA registration.
Key Takeaways
- FDA rules cover food, drugs, devices, and cosmetics.
- Requirements vary sharply by product category.
- Registration is not FDA endorsement.
- Verify supplier claims in the FDA databases.
Frequently Asked Questions
What products need FDA compliance?
Food, drugs, medical devices, cosmetics, and food-contact materials entering the US are subject to FDA requirements, which vary by category — from facility registration to clearance and labelling.
Is FDA registration the same as approval?
No. Registration is an obligation for many products; approval or clearance (such as 510(k) for devices) is a separate, more rigorous process required for specific product types.
How do I verify a supplier's FDA compliance?
Confirm the specific requirements for your product, then verify facility registration and any clearances in the official FDA databases rather than relying on a supplier 'FDA certificate'.
Do food-contact products need FDA compliance?
Yes. Food-contact materials must meet FDA requirements for the substances used. Confirm the specific requirements and obtain supporting documentation.
Can Plutonia help with FDA compliance?
Yes. Plutonia helps identify FDA requirements for your product, verifies supplier registration and clearances, and coordinates testing where needed. Submit your product details to start.