US FDA
FDA 510(k) & US Market Entry
From predicate search to clearance — a clear path into the US medical device market.
What's included
- Predicate device search & substantial equivalence
- 510(k) eSTAR submission preparation
- De Novo Classification Request
- Q-Submission (Pre-Sub) strategy
- FDA Establishment Registration & Device Listing
- US Agent service for foreign manufacturers
- QMSR (21 CFR 820 → ISO 13485 harmonization)
- MDR/MDV (Medical Device Reporting) procedures
Frequently Asked Questions
FDA's MDUFA goal is 90 FDA days. Real-world average including AI (Additional Information) responses is 4–7 months.