FDA Medical Device Establishment Registration
The U.S. Food and Drug Administration (FDA) requires medical device establishments to register before selling their products in the United States. Whether you manufacture, repackage, relabel, or import devices, FDA registration is a critical step to entering the U.S. market.
At USAgentPros, we make the process straightforward and stress-free, giving you the confidence to bring your medical devices to market without unnecessary delays.
Who Must Register?
Most companies involved in medical devices for U.S. distribution must register with FDA, including:
- Manufacturers (domestic and foreign)
- Contract manufacturers and sterilizers
- Repackagers and relabelers
- Specification developers
- Initial importers of devices
In addition to registering, many establishments must also **list their devices** with FDA and identify the activities they perform.
Registration and Renewal Timeline
- Facilities must be registered before shipping products into the U.S.
- Registration is renewed annually (October 1–December 31)
- Device listings must be updated at the time of renewal or when changes occur
Our Medical Device Registration Services
USAgentPros provides full support for device companies seeking FDA compliance:
- FDA Establishment Registration and Annual Renewal assistance
- Medical Device Listing submissions and updates
- DUNS number assistance
- 24/7 U.S. Agent representation for foreign facilities
- Ongoing compliance support and monitoring
Device Classification & Pathways
Every medical device must be classified by FDA into Class I, II, or III. Your device’s classification determines the level of regulatory control required:
- Class I – Lowest risk; many are exempt from premarket notification (510(k))
- Class II – Moderate risk; generally require 510(k) clearance
- Class III – Highest risk; typically require Premarket Approval (PMA)
USAgentPros helps you determine the right classification and regulatory pathway for your device.
Why Register with USAgentPros?
- Dedicated Compliance Pro – A real expert assigned to your project
- Fast Turnarounds – Keep your products moving on schedule
- 100% Money-Back Guarantee – Total confidence in your registration
- Competitive Pricing – Transparent, fair rates with no hidden fees
Start Your FDA Device Registration Today
Don’t risk delays or denials at the border. Partner with USAgentPros for a smooth, reliable FDA medical device registration process that keeps your business compliant and ready to scale.