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CLOSEOUT LETTER

Battelle Memorial Institute MARCS-CMS 610928 —

Product:
Medical Devices

Recipient:
Recipient Name
Jeff Rose
Recipient Title
Vice President Government Relations and Public Policy
Battelle Memorial Institute

505 King Ave.
Columbus, OH 43201
United States

Issuing Office:
Center for Devices and Radiological Health

United States


Dear Mr. Rose:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 610928, dated October 7, 2020). Based on our review of your responses, you have addressed the violations contained in this Warning Letter.

The establishment inspections are considered closed as you have ceased operations and your Emergency Use Authorization (EUA) for the Battelle CCDS’ has been revoked. In the event that Battelle re-enters this product area either through a new EUA or marketing application, the issues identified during the inspections would need to be corrected. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

Following revocation of your EUA, you should continue to report adverse events and maintain all records in accordance with the NIOSH – approved FFR EUA (https://www.fda.gov/media/135763/download). During our call on March 30, 2021, we mentioned maintaining records for 2 years which is considered best practice; however, we would like to note that the linked EUA under which the decontaminated respirators would remain authorized, states that all records should be maintained until otherwise notified by FDA.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,
/S/
Binita S. Ashar, MD, MBA, F.A.C.S.
Director
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

 
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