US FDA Establishment Registration and Device Listing


In the United States, owners and operators of businesses involved in the production and distribution of medical devices, drugs, combination products, dietary supplements, or cosmetics are required to register annually with the FDA. These, FDA Establishment Registration and Listing for Medical Devices, administrative tasks are tedious and often forgotten about resulting in missed deadlines and lapses in their registration certificates which could impact the ability to sell product.

Typically, facilities that are required to register with the FDA also need to list the medical devices that they manufacture on the US FDA Registration and Listing Database. This US FDA Establishment Registration and Listing for Medical Devices database helps the United States to identify manufacturing establishments and the products they manufacture, which would help us to be better prepared for public health emergencies.

For assistance with registration and listing, contact one of our experienced consultants today! And don´t forget your FDA medical device registration, we can make it!

The deadline to renew your annual registration with the FDA is December 31, 2021

To avoid a lapse in registration, don't forget to renew with the FDA your US FDA Establishment Registration and Listing for Medical Devices. We recommend filing by December 1st at the latest to allow for processing time, especially during these uncertain times where things are taking a bit longer than usual. Also, RQMIS can make your US FDA Establishment Registration, and of course the Medical Device listing!

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