Medical device and drug establishments that produce and distribute products for sale within the United States are required to renew their U.S. Food and Drug Administration (FDA) registration annually. Registrar Corp writes to remind the industries that registrations must be renewed for 2018 between October 1, 2017 and December 31, 2017.
Medical device establishments are required to designate an Official Correspondent for FDA communications in their registrations, while drug establishments must designate a Registrant Contact. Additionally, FDA requires all businesses located outside of the United States to appoint U.S. Agents.
Notices for Medical Device Establishments
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.
Why Timely Renewal is Important
Failure to renew FDA registration can have adverse effects. In the past, FDA has removed establishments from its database that did not renew, rendering their registration invalid.
FDA may issue a Warning Letter to a medical device or drug business that manufactures and distributes products for interstate commerce without a valid registration. Shipments from foreign businesses may be denied entry into the United States if their registrations are not renewed. It is prudent for businesses to complete timely registration renewal to help avoid preventable delays from costly detentions or other enforcement actions.
Registrar Corp can assist in the renewal of your medical device or drug establishment registration, facilitate payment of fees with FDA, and issue a third-party certificate that verifies your registration. Additionally, Registrar Corp can serve as your Official Correspondent or Registrant Contact and U.S. Agent.
Alternatively, you can call us at +1-757-224-0177 or you can chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.