Medical Device Establishment Registration and Device Listing ...

Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments.

Establishment Registration & Device Listing - accessdata.fda.gov

Establishment Registration & Device Listing. Quick Search. Search by Company or Device Name. Company Name. Device Name. Advanced Search.

21 CFR Part 807 -- Establishment Registration and Device Listing ...

(a) The Food and Drug Administration will assign each device establishment a registration number after verifying the initial establishment registration ...

FDA CDRH Registration and Listing Requirements | NIH's Seed

Specification developer. Develops specifications for a medical device that is distributed under the establishment's own name but performs no manufacturing. This ...

Establishment Registration & Device Listing with FDA

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.), ...

FDA Establishment Registration and Listing for Medical Devices

Do you need help with completing your initial FDA establishment registration and listing for a medical device? Watch our video to learn how.

Domestic Medical Device Establishment Registration

Every importer of medical device products to the United States must provide to the FDA with the medical device facility registration number for the foreign drug ...

Establishment Registration & Device Listing | HealthData.gov

This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical ...

FDA Medical Device Establishment Registration - Emergo by UL

As a general rule, if you manufacture all or part of a medical device sold in the US, or perform processing (e.g., sterilization) on the device, you must ...

FDA Registration and Listing for Medical Devices

Before registering with the FDA, you must also make a second DFUF payment for the establishment registration fee of $9,280 for FY 2025 (a 21.3% increase from FY ...

21 CFR Part 807 Subpart B -- Procedures for Device Establishments

The registration and listing requirements shall pertain to any person who is engaged in the manufacture, preparation, propagation, compounding, assembly, or ...

Establishment Registration & Device Listing | HealthData.gov

... Listing. This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical ...

FDA Medical Devices Requirements - FDA Specialist

For a complete list of facilities required to register as medical device establishment and facilities that must pay the user fee, visit FDA's registration ...

FDA Establishment Registration and Device Listing

This online portal is the gateway to all FDA registration and listing activities. Ensure you have all the necessary information and documentation ready before ...

FDA Establishment Registration and Device Listing - Alvamed

FDA Establishment Registration and Device Listing FAQ's · Establishment details: Location, ownership, activities performed, contact information. · Device ...

Medical Device Establishment Registration and Device Listing

FDA Listing Inc. provides FDA medical devices establishment registration and medical device Listing and can act as U.S. FDA Agent to Non-US companies that ...

Medical Device Establishment Registration and Listing with US FDA

Complete our online form to register your medical device establishment with FDA. LMG will also help you with FDA 510 K submission, Medical device label ...

FDA Medical Device Registration Consultants - I3CGlobal

FDA Establishment Registration Fee for FY 25 is $9280 · The annual US FDA Agent Fee is $649 · Device listing up to 5 devices $100/device.

Medical Device Establishment Registration And Device Listing

The establishment registration information must be submitted each year between October 1 and December 31. Users fee for fiscal year 2022 increased in 2.30%.

Medical Device Establishment Registration and Device Listing ...

This checklist covers FDA medical device facility registration and medical device listing requirements. Failure to register and list with ...