US FDA Establishment Registration for Medical Device Companies

Any establishment involved in the production or distribution of a medical device for commercial sale in the United States must register annually with the US Food and Drug Administration (FDA). If your company manufactures or distributes devices within the US, you must obtain an FDA Establishment Registration in order to enable the FDA to protect public health and respond to public health emergencies.

Depending on the type(s) of activities you perform, FDA establishment registration also requires you to list the devices as well as activities performed related to each device at your firm. You must also register with the FDA if you are an initial distributor with a US address taking first title to a device imported into the country.

The first step in the FDA establishment registration process is generally payment of the establishment registration fee. Emergo Group can both facilitate this payment process and manage your FDA establishment registration to ensure compliance.

Emergo Group can register your medical device company with the US FDA

As a medical device regulatory consultancy with hundreds of clients worldwide, Emergo Group can determine whether you need to apply for an FDA Establishment Registration, and subsequently complete the registration with the FDA on your behalf. If needed, we are also able to assist with assessing the classification and choosing the appropriate Product Code(s) for your medical device(s).