FDA Medical Device Registration Renewal
About FDA Medical Device Registration Renewal
Domestic and foreign medical device establishments registered with the US FDA must renew their FDA registration every year between October 1st and December 31st.
Foreign manufacturers whose products are available in the US Market must identify all US Importers at the time of registration renewal. US Importers must identify all foreign manufacturers at the time of registration renewal. The renewal fee is identical for all Medical device establishments which require FDA registration.
If you did not complete registration renewal on time, the FDA may remove registration and listing information from the FDA site and consider your products misbranded. If you need assistance with FDA renewal, please contact us.
There is no renewal of FDA 510(k) clearance — only the medical device establishment registration must be renewed annually. The device listing must also be reviewed and updated during the renewal period.
LMG will issue an FDA registration renewal certificate free of cost after completing the registration renewal. You can use this certificate as proof of FDA registration renewal to your customers and trading partners.
- Registration must be renewed annually between October 1 and December 31
- Device listing must be reviewed and updated during the renewal period
- Failure to renew results in products being deemed misbranded
- LMG issues a free renewal certificate as proof of completed renewal
- Either the facility owner or the US FDA Agent can complete the renewal
Medical Device Renewal Services — How LMG Can Help
Renewal Submission
Complete preparation and submission of your annual medical device establishment registration renewal. LMG manages the entire FDA portal process, verifies all establishment information, processes MDUFA fee payments, and obtains immediate confirmation of successful submission.
Device Listing Update
Review and update of your medical device listing during the renewal period to keep all listings active. We audit your complete product portfolio, add newly marketed devices, update trade names and model numbers, and verify premarket submission references to prevent inactive status.
Renewal Certificate
LMG issues a free FDA registration renewal certificate as proof of completed renewal. This professional certificate includes your Owner/Operator Number, Registration
or FEI Number, renewal date, and validity period, satisfying customer and distributor documentation requirements.
Deadline Tracking
LMG tracks the October 1 – December 31 renewal window to ensure your registration never lapses. We send advance reminder notifications at 90, 60, and 30 days before the deadline and initiate contact early to schedule optimal submission timing for your establishment.
Frequently Asked Questions
When must medical device registration be renewed?
Does 510(k) clearance need to be renewed?
What happens if renewal is not completed on time?
Does LMG issue a certificate after device renewal?
Need Help with Device Registration Renewal?
LMG manages the complete renewal — submission, listing update, and free renewal certificate issuance.
Start Renewal Process Contact Us