Medical device establishments must renew their FDA registration every year between October 1 and December 31 — not every two years like food facilities. The FY2026 government fee is $11,423, a real cost that increases most years.
Start My Renewal → Renewal FAQQuick answer: If your facility manufactures, repackages, relabels, or imports medical devices for the U.S. market and is currently FDA-registered, you must renew that registration every year between October 1 and December 31 — this is an annual requirement, unlike food facility registration's two-year cycle. The FY2026 FDA government fee is $11,423, separate from any service provider's fee. Foreign establishments must also maintain a valid U.S. Agent.
If you also handle food facility registration for the same company, it's easy to assume every FDA renewal follows the same two-year cycle. Medical device registration doesn't. It renews every single year, October 1 through December 31, without exception for the "off year." Missing even one annual cycle can suspend your registration and device listing.
Unlike food facility registration, which has no FDA fee at all, medical device establishment registration carries a genuine, substantial annual government fee, set under the Medical Device User Fee Amendments (MDUFA):
This fee has no small business discount by default and no proration — it's a flat rate for all establishments required to pay it. A separate Small Business Determination (SBD) Program waiver exists (see below), but it isn't automatic.
The FDA may waive the annual registration fee (though not the initial registration fee) for small businesses that meet all of the following:
This waiver must be requested through FDA's Small Business Determination (SBD) Program and is granted at FDA's discretion — it isn't applied automatically just because your business is small.
Your establishment registration and device listing can be suspended if not renewed by December 31.
Devices from an unregistered establishment may be considered misbranded under the FD&C Act.
Foreign manufacturers risk shipment detention if registration lapses.
FDA has issued warning letters to device makers for failing to complete annual renewal on time.
Every year, October 1 through December 31 — an annual requirement, not biennial like food facilities.
$11,423, covering October 1, 2025 through September 30, 2026 — a real FDA government fee, up 23.1% from FY2025.
Not by default. A separate waiver exists through the SBD Program for businesses meeting specific financial hardship criteria, granted at FDA's discretion.
Registration and device listing can be suspended, and your devices may be considered misbranded — real enforcement risk, not just a paperwork lapse.
Annual renewal — mark your calendar for every year, not just this one.
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