Delivery Method: VIA Electronic Mail Product: Medical Devices


Recipient Name

Mr. Mark A. Augusti

Recipient Title

President, CEO

Conformis Inc.

600 Technology Park Dr.
Billerica, MA 01821
United States

Issuing Office: Office of Medical Device and Radiological Health Operations

United States

Dear Mr. Augusti:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 596362) issued on December 12, 2019. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

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.

Gina Brackett
Director, Compliance Branch
Office of Medical Device and Radiological Health Division 1