FDA Registration Renewal: 7 Steps for FY 2027

October 1 marks the start of the FDA's annual registration renewal period. Every medical device establishment that has to register must renew between October 1 and December 31 (21 CFR 807.22(b)). If you miss the deadline, your facility is not legally registered for the new fiscal year. 

This year brings a higher fee, a new waiver option for small businesses, and a new quality management system standard that FDA inspects against. Small mistakes, like failing to pay on time, submitting outdated device listings or never getting final confirmation from FDA, can leave a facility unregistered without anyone realizing it. 

Let us handle it. SafeLink Consulting manages FDA registration renewals for medical device manufacturers and dental laboratories every year. Call 770-205-6745 or contact us to get your renewal done right and on time. 

1. Confirm You Need to Register at All: 

This matters more than many facilities realize, especially dental laboratories. FDA exempts some devices and some practitioners, but in 2025 it issued a warning letter to a dental lab that claimed an exemption and cited it for failing to register. If your business has changed (new products, direct-to-consumer sales, new partners), your status may have changed too. See our guide, FDA Establishment Registration: A Guide for Dental Laboratories.

Stopped manufacturing? Don't just let your registration lapse. That can prompt FDA to follow up, sometimes with an inspection. Call us to update your status correctly.

2. Get Your Accounts in Order 

Renewal involves two separate FDA systems with separate logins. Being locked out in late December is one of the most common reasons renewals run late. 

3. Pay the FY 2027 Fee: $13,875

The annual establishment registration fee is $13,785, about 21% higher than last year. Payment must be completed before your registration counts, and processing can take several days.

New for small businesses: FDA may waive the annual fee for businesses with $1 million or less in gross receipts that can show financial hardship. Waivers aren't automatic and require advance qualification. Ask us whether your business may qualify.

4. Submit Your Annual Registration 

 Submit your renewal online through FDA's registration system before December 31.

5. Review Your Facility and Device Listings

Outdated addresses, contacts or device listings are among the most common registration problems FDA flags. Any changes to products, location or ownership since last year need to be reflected.

6. Confirm FDA Has Completed Your Registration

Submitting isn't the finish line. Keep your FDA confirmation and registration information for your records, and verify that your registration and device listings are current for the new fiscal year.

7. Stay Inspection-Ready All Year

Registration is not FDA approval, and you shouldn't describe it that way in your marketing. What it does mean is that FDA knows you exist and can inspect you at any time.

As of February 2, 2026, FDA's Quality Management System Regulation (QMSR) is in effect. The QMSR incorporates ISO 13485:2016 by reference, with FDA-specific provisions and requirements. Quality systems built under the old rule may have gaps under the new one, and inspectors are looking for them.

Not sure your quality system is QMSR-ready? SafeLink can review it before FDA does. Contact us or call 770-205-6745 or contact us.

Need help with your FDA registration renewal? SafeLink Consulting manages FDA registration renewals for medical device manufacturers and dental laboratories. Call 770-205-6745 or email info@safelinkconsulting.com to discuss your renewal. The December 31 deadline comes fast.