US FDA Agent Service & Device Registration
Official United States Agent representation, annual establishment registration, FURLS electronic device listing, and full 510(k) submission support for overseas medical device and IVD manufacturers entering the US market.
Prior Registration & Classification for US Market Entry
Prior to exporting any medical device or in-vitro diagnostic (IVD) to the United States, the device must be formally registered with the US FDA (Food and Drug Administration) and fulfill all statutory FDA regulatory guidelines.
Before US FDA registration can proceed, the device must first be correctly classified into its statutory product code to determine the appropriate regulatory pathway. While the broad classification categories remain consistent (Class I, Class II, and Class III), the US FDA classification criteria differ slightly from European CE Marking rules:
Most Class I and select Class II devices are 510(k) Exempt, requiring direct establishment registration and listing.
Most Class II devices require a 510(k) Premarket Notification (PMN) clearance demonstrating substantial equivalence.
Life-sustaining or high-risk devices require rigorous PMA approval backed by comprehensive clinical data.
21 CFR 807.40 Foreign Establishment Rule
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment.
Device Registration Pathways
Understanding the compliance, fee, and audit requirements for both 510(k) Exempt and 510(k) Premarket Notification products.
Device Registration of 510(k) Exempt Products
Devices that are 510(k) exempt do not require premarket clearance documentation, but they must still be registered and listed with the FDA before commercial importation into the US.
- Annual Registration Fee: Prior to registration, the FDA annual establishment registration user fee must be paid for the active fiscal year.
- US Agent Mandate: Any manufacturer not residing in the US must appoint an official US Agent to execute and maintain the registration.
- Random FDA Audits: After registering devices with the FDA, the facility becomes subject to random FDA inspections (21 CFR Part 820 / QMSR). Your products and quality management systems must maintain continuous compliance.
Device Registration of 510(k) Products
For devices that are not 510(k) exempt, the manufacturer is strictly required to obtain 510(k) clearance first. Only after receiving the formal FDA clearance letter can the product be listed on the FDA FURLS database.
- Dual Fee Structure: There are two separate fees — one for the 510(k) premarket review and a separate annual establishment registration & listing fee.
- Annual FY Fee Revisions: Both fees are revised by the FDA each Fiscal Year (FY) under MDUFA mandates and published on the official FDA website.
- Small Business Qualification (SBD): Small businesses with gross receipts under $100M can qualify for substantial fee reductions on 510(k) review fees (note: there is no reduction on establishment registration fees).
Why Partner with NKB Regovanta for US FDA Representation?
NKB Regovanta brings extensive experience in medical device product registration and successful 510(k) submissions. We guide overseas manufacturers through every phase of US FDA market authorization.
Official U.S. Agent Representation
Acting as your statutory US Agent under 21 CFR 807.40, serving as the official liaison between your foreign facility and the FDA.
510(k) Dossier & Submissions
Premarket Notification dossier compilation, predicate identification, substantial equivalence defense, and eSTAR submissions.
FURLS Registration & Listing
Management of PIN, Payment Identification Number (PIN/PCN), annual registration fee coordination, and electronic device listings.
FDA Audit & QMSR Readiness
Preparing foreign manufacturing sites for FDA Quality Management System Regulation (QMSR / 21 CFR 820) inspections.
Request U.S. Agent & FDA Registration Consultation
Connect with our US regulatory specialists for product classification, US Agent appointment, and 510(k) clearance roadmaps.