The fees
The fees: $11,423 for FY2026, $13,785 for FY2027 — paid before registration, no small-business discount.
Free field guide · PDF
FDA Establishment Registration2026 Field Guide
The fees, the window, and the foreign-establishment rules — with the FDA practice you need.
- FY2027 fee
- $13,785
- Deadline
- Dec 31
- Foreign rule
- US Agent
Sourced from verified 2026 publications.
Download the free guide
Enter your work email and we'll send the PDF straight to your inbox.
What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The window
The window: Oct 1 – Dec 31 annual renewal, hard Dec 31 deadline — the FURLS sequence and the miss consequences.
The foreign-establishment rules
The foreign-establishment rules: US Agent, official correspondent, and rolling device-listing updates.
Sources & scope
- fdaregistrationassistance.com, FDA Medical Device Registration & Listing Services.
- fdabasics.com, FDA Medical Device Registration Services.
- legalclarity.org, 21 CFR Part 807: Establishment Registration and Device Listing.
This guide is market-access intelligence, not regulatory or legal advice. FDA registration fees, deadlines, and requirements change annually — professional review is required before business use.
Market Access Strategy Session
US registration on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your US route — registration, listing, and agent strategy.
Professional review is required before business use.
Back to ghmap.io Questions? Talk to our team