FDA Medical Device Registration Renewal 2026 – Important Notes

FDA Registration Renewal Timeline and Fees

The renewal period for FDA medical device establishment registration for fiscal year 2026 runs from October 1, 2025 to December 31, 2025. The mandatory fee payable to the FDA for this fiscal year is $11,423.

Small Business Determination (SBD) Fee Waiver Policy

Businesses with revenue not exceeding $1 million may qualify for a renewal fee waiver, except for first-time registration. The SBD application window runs from August 1, 2025 to October 31, 2025. The application must include financial documentation along with confirmation that the business has completed its prior-year fee payment obligation.

U.S. Agent Requirement

For manufacturing or distribution facilities located outside US territory, a business is required to have a U.S. Agent when registering or renewing with the FDA. The U.S. Agent serves as the official point of contact with the FDA, receiving notices, correspondence, and providing support in emergency situations. U.S. Agent information must be accurately declared in the FURLS system, and the agent must confirm acceptance of this role with the FDA. If the U.S. Agent declines or doesn’t confirm, the renewal application won’t be accepted by the FDA. Businesses should therefore choose a U.S. Agent with experience and the ability to respond quickly and accurately to ensure compliance.

New Quality Management System Regulation (QMSR)

Starting February 2, 2026, the FDA will apply a new Quality Management System Regulation (QMSR). This regulation is built on a framework incorporating the ISO 13485:2016 standard, replacing the previous regulation set out in 21 CFR Part 820. Businesses need to review, update, and adjust their current quality management system to ensure alignment with and compliance with the FDA’s new regulation.