FDA Compliance for Medical Devices
The U.S. medical device market is one of the largest in the world, but it comes with strict FDA requirements. From establishment registration to device listing and product classification, medical device companies must meet regulatory standards before products can be sold in the U.S.
USAgentPros helps device manufacturers, importers, and distributors navigate these rules with confidence.
Key FDA Requirements for Medical Devices
Establishment Registration – All manufacturers, contract manufacturers, repackagers, relabelers, and importers must register with FDA.
Device Listings – Each device marketed in the U.S. must be listed with FDA.
Classification – Devices are assigned to Class I, II, or III, which determines regulatory controls.
Premarket Submissions – Some devices require FDA clearance (510(k)) or approval (PMA) before sale.
U.S. Agent Representation – Required for foreign facilities.
Our Device Compliance Services
- FDA establishment registration and renewals
- Device listing preparation and submission
- Support for classification and regulatory pathway guidance
- 510(k) and PMA consulting assistance
- U.S. Agent representation for foreign companies
Why Device Companies Trust USAgentPros
Dedicated Compliance Pro – Expert guidance every step of the way
Fast Turnarounds – Keep your devices on schedule for launch
100% Money-Back Guarantee – Confidence in every service
Competitive Pricing – Reliable compliance at fair rates
Enter the U.S. Market with Confidence
Bring your medical devices into the U.S. with the right FDA registrations and listings in place.