Service overview
We register your medical device or cosmetic facility with the FDA, act as US Agent for foreign facilities and manage each annual renewal.
Why this service matters
- The FDA requires device and cosmetic facilities serving the US market to register.
- Foreign facilities must designate a US Agent.
- Non-compliance can mean refusal of entry, enforcement action and warning letters.
Initial FDA Medical Device Registration
We manage the full FDA facility registration process for medical device and cosmetic facilities.
- Facility details entry, including activities and product categories
- Confirmation of registration completion with FDA registration number issuance
- US Agent designation for foreign facilities
FDA Registration for Medical Device & Cosmetic Facilities
Annual FDA Registration Renewal
Medical device registrations must be renewed each year between 1 October and 31 December, and we manage each renewal.
- Annual renewal submissions to maintain active FDA registration
- Monitoring of regulatory updates affecting renewal requirements
- Immediate updates on renewal status and compliance notifications
Medical Device Listing Services
Device manufacturers must list every device intended for US distribution, and we handle listings in line with FDA requirements.
- FDA medical device listing submissions via FURLS
- Support for device modifications and updates in FDA records
- Annual listing maintenance and re-submissions as required
Cosmetic Product Labelling & Ingredient Compliance Support
The FDA does not pre-approve cosmetics, but facilities must meet labelling and ingredient safety rules under the FD&C Act.
- Review of cosmetic product labels for FDA compliance
- Ingredient analysis for restricted or banned substances
- Country of origin labelling and manufacturer details verification
US Agent Representation for Foreign Facilities
Foreign manufacturers must appoint a US Agent to handle FDA communications and emergency enquiries, and we provide this service for device and cosmetic facilities.
- Official US Agent designation for FDA registration purposes
- Support for regulatory enquiries and compliance notifications
- Assistance with post-market surveillance requirements
FDA Registration Amendments & Updates
Changes such as ownership transfers, new addresses or product expansions must be updated with the FDA promptly.
- Device listing modifications to reflect new products or changes
- Timely updates to avoid registration invalidation
- Verification of submission acceptance by the FDA
Ongoing compliance support
Time-Saving
We handle registration, listing and renewal submissions, so deadlines don't catch you out.
Regulatory Assurance
Keep facility registrations and device listings current with FDA requirements.
Peace of Mind
Reduce the risk of refused entry, enforcement action and shipment delays.
What you'll need
Registration needs accurate facility and device information.
- Facility detailsActivities and product categories at the site.
- A US AgentDesignated for foreign facilities.
- Device listDevices to list or update in FURLS.
- Changes since last updateNew products or changes that affect your listing.
Official sources
- 21 CFR Part 807: Establishment Registration and Device Listing (eCFR)
- 21 CFR Part 807 Subpart E: Premarket Notification (510(k)) (eCFR)
- 21 CFR Part 820: Quality Management System Regulation (eCFR)
- Device Registration and Listing (FDA)
- Premarket Notification 510(k) (FDA)
- 21 CFR Part 1 Subpart H: Registration of Food Facilities (eCFR)
- Registration of Food Facilities and Other Submissions (FDA)
- 21 CFR Part 701: Cosmetic Labeling (eCFR)
- Modernization of Cosmetics Regulation Act of 2022 (FDA)