Register a New Medical Device Facility

Device Registration and Listing · Phone: 301-796-7400 · Email: [email protected].

Carefully read the introductory information before you start registering your facility. The process should take no longer than 20 minutes.

FAQ: Medical Device Facility Registrations - FDA Solutions Group

WHAT IS THE MEDICAL DEVICE FACILITY REGISTRATION REQUIREMENT? The FDA requires facilities that are manufacturing, preparing, propagating, compounding, ...

What is the FDA Medical Device Registration Process?

After your initial registration, you are required to complete an annual registration with FDA for each fiscal year between October 1 and ...

FDA Establishment Registration and Listing for Medical Devices

... registration and listing for a medical device? Watch our video to learn how. The two most common situations for when a company needs to register ...

FDA Registration and Listing for Medical Devices

A few weeks before you submit your first 510k to the FDA, it is recommended that you create a new account for the user fee website and make your Device Facility ...

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

FDA medical device registration steps · Classify your medical device · Collaborate with the FDA prior to your submission · Prepare the appropriate ...

Domestic Medical Device Establishment Registration

Register or renew registration for your ... medical device facility registration number for the foreign drug manufacturer and importer/distributor.

FDA Medical Device Establishment Registration - Emergo by UL

Set up an account for you in the FURLS system, if your company is new to the US market · Facilitate payment of appropriate fees, which is necessary BEFORE the ...

Registering and Listing Your Medical Devices for 2024 - MDC

Over the next three months, medical device manufacturers must update or complete the registration and listing of their devices and facilities ...

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

FDA registration is mandatory for all businesses involved in the commercialization of medical devices in the United States.

FDA Medical Device Registration Process: A Step-by-Step Guide for ...

Establishment Registration is a formal declaration to the FDA of your business operations, ensuring that your company is recognized as a ...

U.S. FDA Medical Device Establishment Registration - Garg Law

Domestic medical device facilities must register their facility within 30 days of putting a device into commercial distribution. Foreign establishments must ...

Medical Device registration in the U.S.A. - Thema Med

In order to be marketed in the United States, all Medical Devices must be registered with the FDA. Manufacturing facilities are subjected to FDA inspections to ...

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

... Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm.1432 ...

FDA Registration Requirements - Registrar Corp

Medical device companies are required to register with FDA before shipping products to the U.S. and must renew their registrations annually between October 1 ...

FDA CDRH Registration and Listing Requirements | NIH's Seed

(DRLM) option followed by the “Register a Medical Device Facility” link. ... Creating a new account will prevent you from accessing your current registration.

FDA Medical Device Registration Services - FDABasics

Companies who are involved in manufacturing, testing, packing, labeling, sterilization, or import of medical devices are required to register their facility, ...

FDA Regulatory Requirements for New Medical Devices

These include facility registration, device listing, device approval, clinical studies, quality systems, labeling requirements and medical device reporting.

Medical Device 510k Submissions, Facility Registration, PMA

The process of bringing a new medical device to the market involves thorough evaluation and regulatory approval to ensure patient safety and efficacy.