U.S. FDA Medical Device Establishment Registration & Listing Requirements
 |
The U.S. FDA is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee.
|
If you are not registered with U.S. FDA
Registrar Corp's team of Medical Device Regulatory Specialists provides guidance on required elements, formats, and particularities of submissions, including:
- Help determining whether registration exclusions apply and, if not, we will prepare and submit your registrations with U.S. FDA and make changes, updates and cancellations as needed at no extra cost.
- Assistance determining if U.S. FDA Medical Device User Fees are required for your registration and, if so, help prepare and submit your payment per U.S. FDA's requirements.
- Issuance of Certificates of Registration to assure customers that you have a valid U.S. FDA Registration as well as prevent the accidental loss of your critical information.
Register Your Medical Device Establishment With The U.S. FDA ››
|
|
|
If you are already registered with the U.S. FDA
Select one of the following options:
|
 |
|
Option 1: Order a Certificate of Registration
|
Companies registered with U.S. FDA often are asked by their customers and suppliers to verify their registration. A Certificate of Registration issued by Registrar Corp serves to verify your compliance with the registration requirement of the U.S. Food, Drug and Cosmetic Act.
- The Certificate helps assure your customers and suppliers that your Medical Devices have been properly listed with U.S. FDA.
- Sending a copy of your Certificate along with each shipment may help to avoid errors and delays.
- Once a Certificate has been ordered, you will periodically receive simplified forms enabling us to quickly update your information on file with U.S. FDA. Such reminders help ensure that your U.S. FDA registration data remains accurate and prevents the accidental loss of your critical information.
Order a Certificate of Registration for Your Device Establishment ››
|
|
| |
|
Option 2: If You Have Lost Your U.S. FDA Registration Information
|
Companies often misplace their registration information. If you do not have your U.S. FDA Medical Device FURLS information, you will not be able to update your Medical Device registration information as required by U.S. FDA. For assistance recovering your U.S. FDA FURLS and registration information, click below.
Recover U.S. FDA Registration Information for Your Device Establishment ››
|
|
| |
|
Option 3: List Additional Medical Devices With U.S. FDA
|
Most establishments that are required to register with the U.S. FDA are also required to list the devices and the activities that are performed on those devices. Registrar Corp's team of Medical Device Regulatory Specialists provides guidance as to required elements, formats and particularities of medical device listings such as:
- Assisting you in determining your device's likely classification
- Prepares and submits your device listings to U.S. FDA and make changes, updates and cancellations as needed
- Issuance of Certificates of Registration to assure customers that you have a valid U.S. FDA Registration as well as prevent the accidental loss of your critical information.
List Additional Medical Devices with U.S. FDA ››
|
|
| |
|
Option 4: Change U.S. FDA Official Correspondent and U.S. Agent |
It is prudent to separate commercial relationships from the responsibilities of your Official Correspondent for U.S. FDA communications because of potential conflicts of interests. Correct this by designating Registrar Corp as your Official Correspondent for U.S. FDA Communications and receive your Certificate of Registration issued by Registrar Corp.
Change U.S. Agent for U.S. FDA Communications ››
|
|
|
|
 |
|
| |
U.S. FDA Regulations:
U.S. FDA Medical Device Regulation: 21 C.F.R. Part 801 et seq.
|
| Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
|
|
