U.S. FDA Establishment Registration & Device Listing Service
Support for FDA establishment registration and medical-device listing, including standard listing and 510(k)-exempt routes. EXIMIO can coordinate classification checks, account setup, U.S. agent information and listing submission steps.
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Service Overview
This service is intended for manufacturers that need support with U.S. FDA establishment registration and device listing. Standard device listing and 510(k)-exempt routes share the same market-entry operations, so they are more useful as variants of one product than as separate pages.
Process Flow & Timing
Select a route below to view the workflow and timing.
Standard Device Listing
Indicative project timeline70–90 daysSource estimate; not statutory
FDA Device Listing
Product Classification
Establishment / Device Information
Confirm U.S. Agent
Establishment Account Confirmation
Complete Device Listing
Device Listing Number
510(k) Exempt / Listing Route
Indicative project timeline~90 daysSource estimate; not statutory
510(k)-Exempt Registration / Listing
Confirm U.S. Agent
Apply for D-U-N-S
Pay Annual Fee
Establishment Registration
Product Classification
Company & Device Information
Device Listing
FDA Registration / Listing Review
Establishment Registration Number
Product Listing Number
Establishment registration ~90 days
Regulatory Basis & Official References
Legal and regulatory references below link directly to the relevant government regulator, official legislation database or official legal text. The applicable provisions should still be confirmed against the device classification, intended purpose and market-access route at project start.
Law21 CFR Part 807FDA establishment registration, device listing and premarket-notification provisions.Open official source ↗Official GuidanceFDA Device Registration and ListingFDA overview of establishment registration and device-listing obligations.Open official source ↗Official GuidanceFDA — When to Register and ListCurrent FDA timing and role-based registration/listing guidance.Open official source ↗
Related Regulatory Support
510(k), De Novo, PMA, 513(g), Pre-Submission and UDI services are available as related FDA support.
EXIMIO Support
Contact EXIMIO BIOTEC for pathway confirmation, document-gap review, submission planning, technical-document preparation, authority communication support and a project-specific quotation.