Medical Device and Drug Companies Must Renew Their FDA Registrations Between Oct. 1, 2021 and Dec. 31, 2021

The U.S. Food and Drug Administration (FDA) requires medical device and drug establishments that produce and distribute products for use within the United States to renew their FDA registration annually. These businesses must renew their registrations for 2022 between October 1, 2021 and December 31, 2021.

Continue reading to learn about renewal requirements and what can happen if you miss the renewal deadline.

Medical Device Establishment Renewal Requirements

FDA-registered medical device establishments must designate an Official Correspondent who is responsible for annual registration. Medical Device establishments located outside of the United States must also designate a U.S. Agent. Medical Device Establishments must list their U.S. Agent in the FDA Unified Registration and Listing System (FURLS). If the listed Agent doesn’t accept their designation through FURLS in 10 days, the business must list another Agent. An establishment’s registration renewal is not complete until an Agent has accepted the designation.

FDA requires Medical Device Establishments to pay an Annual Establishment Registration fee. The annual fee for Fiscal Year (FY) 2022 is $5,672, a slightly higher cost than the FY 2021 fee of $5,546.

Drug Establishment Renewal Requirements

Drug Establishments must designate a Registrant Contact that FDA can contact regarding establishment registration information. Drug companies located outside of the U.S. must also list a U.S. Agent.

As part of the renewal, registered drug establishments must also submit a “Blanket No Change Notification” for all product listings that have not been updated during the current year to certify there were no changes to the data or labeling. The notification must be submitted in structured product labeling (SPL) format.

In 2021, FDA implemented user fees for registered establishments manufacturing or processing finished dosage forms of most OTC drugs under the OTC Monograph User Fee Program (OMUFA). OMUFA fees are not due at time of registration, but drug establishments registered in 2021 may be subject to them in June of 2022.

Consequences of a Missed Renewal

FDA considers registrations that are not renewed by the December 31 deadline to be “expired.” FDA has previously removed establishments that did not renew from its database shortly after each renewal period. For example, in February 2021, FDA canceled 31% of medical device registrations for failure to renew.

Distributing medical devices or drugs in the United States with an expired registration is prohibited and may subject an establishment’s owner to civil or criminal penalties. FDA may issue a Warning Letter to a medical device or drug business that manufactures and distributes products for sale in the United States without a valid registration. Shipments entering the United States from businesses with expired registrations may be detained and refused at the U.S. port of entry. Timely registration renewals help prevent 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 third-party confirmation of your registration to industry. Additionally, Registrar Corp can serve as your Official Correspondent or Registrant Contact and U.S. Agent.

Renew a Medical Device Establishment Registration here.

Renew a Drug Establishment Registration here.

Alternatively, you can call us at +1-757-224-0177 or you can chat with a Regulatory Advisor 24 hours a day at https://www.registrarcorp.com/livechat.

Don’t wait! Renew your
FDA registration today.

Registrar Corp will help you re-register with FDA quickly and properly.

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

single-box-image

Subscribe To Our News Feed

To top