While there are no major changes this year for drug establishments, medical device businesses should be aware of two important updates for their 2018 renewals:
The 2018 user fee for medical device establishment registration is $4,624, a steep increase of $1242 from 2017. All medical device establishments that are required to register must pay this fee, regardless of whether or not they qualify as a small business for other medical device user fees.
As mentioned previously, foreign medical device establishments are required to designate U.S. Agents in their registrations. The 2018 renewal period marks the first time that designated U.S. Agents must verify their agreement to serve this function. Once an Agent’s information is entered into the FDA Unified Registration and Listing System (FURLS), the system will issue them a verification email. Agents will have ten days accept their designation through FURLS. If a device establishment’s U.S. Agent does not accept, a new Agent must be designated or the registration may be considered invalid for 2018.
