How to Register and List

The registration of a medical device establishment is a two-step process. First you must pay the annual registration user fee.

Who Must Register, List and Pay the Fee - FDA

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United ...

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.

FDA CDRH Registration and Listing Requirements | NIH's Seed

Whether or not a premarket application or approval is required, an innovator seeking to market a medical device in the U.S. is required to register and list the ...

FDA Registration and Listing for Medical Devices

This article and the associated video will help you complete your FDA registration and listing. Small Business Status does not apply to FDA registration.

What is the FDA Medical Device Registration Process?

The purpose of registering and listing a medical device is to provide FDA with the location of all facilities involved in the manufacture of a medical device.

Establishment Registration & Device Listing | HealthData.gov

... Registration & Device Listing. This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly ...

How and When to Register Your Establishment with the FDA & Who ...

Pay your annual registration fee · Log into FURLS · Complete or update the Device Registration & Listing Module (DRLM) · Download your listing ...

FDA Medical Device Establishment Registration - Emergo by UL

List your device using the FDA Device Registration and Listing Module (DRLM). If needed, we can also assist with assessing the classification and choosing the ...

FDA Establishment Registration and Device Listing - Alvamed

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

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 and ...

Establishment Registration & Device Listing with FDA

To register a medical device establishment with FDA is a two-step process: Step-1: Payment of the annual registration user fee: The establishment must pay the ...

FDA medical device registration process - getting new products to ...

... list the devices and the activities performed on those devices at the establishment. Registration and listing information must be submitted ...

Device Registration and Listing Part 1

In this CDRH Learn module, Elias Mallis will discuss the most foundational aspects of the medical device regulations: Device Registration and Listing.

US FDA Establishment Registration and Device Listing - RQMIS

This US FDA Establishment Registration and Listing for Medical Devices database help the United States to identify manufacturing establishments and the products ...

Facility Registration & Listing - FDAImports

One of the most basic requirements for selling FDA-regulated products is to make sure they are properly registered and sometimes listed with the FDA. The FDA ...

FDA Registration and Listing / U.S. Agent

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

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 ...

How to List a Property - National Register of Historic Places (U.S. ...

Where to Start. The National Register nomination process usually starts with your State Historic Preservation Office* (SHPO). Contact your SHPO ...

Medical Device Registration Listing - John Snow Labs

This dataset shows owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution ...