US FDA Registration for Medical Devices: Establishment Registration and Device Listing

Before a medical device can be sold in the United States, the companies that make and import it must register with the FDA and list their devices. Medfins International handles FDA establishment registration, FDA device listing and US Agent coordination for manufacturers in India and worldwide, so your registration is correct, on time and renewed every year.

What is US FDA registration for medical devices?

Under 21 CFR Part 807, owners and operators of establishments involved in producing and distributing medical devices for the US market must register those establishments with the FDA and list the devices made or processed there. Registration tells the FDA who you are and where you operate; listing tells it which devices you handle. Neither is an approval: the FDA does not issue registration certificates, and any company offering an “FDA certificate” is selling something the agency does not recognise.

Who must register?

• Manufacturers, including contract manufacturers and contract sterilisers
• Specification developers who sell under their own name
• Repackagers and relabelers
• Initial importers of devices into the United States
• Foreign manufacturers and foreign exporters of devices to the United States

FDA establishment registration: the process

1. Confirm the device pathway: 510(k), De Novo, PMA or exempt. Registration is required in every case, but the device must be cleared or approved before marketing unless it is exempt.
2. Pay the annual establishment registration fee through the FDA user fee system and obtain the payment confirmation.
3. Register the establishment in FDA’s Unified Registration and Listing System (FURLS / DRLM) within 30 days of beginning operations.
4. List each device with its product code, regulation number and the 510(k) or De Novo number where applicable.
5. Designate a US Agent (foreign establishments only); the FDA contacts the agent to confirm the appointment.
6. Renew every year between 1 October and 31 December, and update listings when devices change.

FDA registration fee for FY2027

The FDA sets user fees every fiscal year. For FY2027 (1 October 2026 to 30 September 2027) the annual establishment registration fee is USD 13,785. Unlike the 510(k) fee, there is no automatic small business reduction for registration. For reference, the FY2027 510(k) fee is USD 28,653, or USD 7,163 for qualifying small businesses.

US agent for FDA registration

Every foreign establishment must name a US Agent who lives or has a place of business in the United States. The US Agent is the FDA’s point of contact for routine and emergency communications, helps schedule inspections and must be available during business hours. The US Agent is not the same as your importer or distributor, although one company can hold several roles. We coordinate a reliable US Agent and keep the details current in FURLS.

US FDA approval for medical devices from India

Indian manufacturers exporting to the United States need three things in place: the right marketing authorisation for the device (often a 510(k) submission), establishment registration and device listing, and a quality system that meets 21 CFR Part 820 (the QMSR). Since 2 February 2026 the QMSR aligns the US requirements with ISO 13485:2016, so a well-run ISO 13485 system is now the foundation for FDA compliance as well.

What Medfins does for you

• Device classification and product code research to confirm the regulatory pathway
• First-time FDA establishment registration and device listing in FURLS
• Annual renewal reminders and filing in the October to December window
• US Agent coordination and FDA correspondence
• QMSR gap assessment, mock FDA inspection and support with Form 483 responses

Ready to start? Book a free consultation with Medfins International or call +91 85270 48221.

Frequently asked questions