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21 CFR Part 807 Compliance

FDA Establishment Registration & Device Listing

We support initial registration, device listing and annual maintenance while checking that the administrative registration activity remains aligned with the device's actual regulatory status and market authorization pathway.

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What This Service Is

FDA establishment registration and device listing are recurring administrative requirements for applicable establishments and devices. They are distinct from premarket clearance or approval and must accurately reflect the manufacturer, establishment and marketed device information.

When It Is Needed

Before applicable establishments begin commercial distribution in the US
During annual establishment registration renewal (October 1 – December 31)
When new devices are added or existing listings change
When ownership, establishment information or US Agent details change
When manufacturing or corporate changes affect existing registration data

Our Support

Initial establishment registration
Device listing in FURLS / DRLM
Annual registration renewal & MDUFA user fee management
US Agent coordination & verification
Registration data review & audit readiness
Updates following company, site or product changes
Assessment of whether registration activity is consistent with the device regulatory status
Our Difference

Regulatory Integrity Beyond Data Entry

We do not treat registration as a data-entry task. We verify that the registration and listing position is consistent with the device's actual regulatory pathway and commercialization status.

Registration Essentials

  • Annual MDUFA facility fee payment required
  • FURLS / DRLM listing of all device models
  • US Agent confirmation required for foreign sites

Need Registration Assistance?

Fast-track your FDA establishment registration and device listings accurately.

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Ready to Register Your Facility with the FDA?

Our regulatory specialists manage your establishment registration and device listings smoothly.

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