ConforMIS Inc.

07/30/2021 | Press release | Distributed by Public on 07/30/2021 16:59

Warning Letter Resolution (Form 8-K)

Warning Letter Resolution

On July 28, 2021, Conformis, Inc. ('the Company') received a letter from the U.S. Food and Drug Administration (the 'FDA') stating that the FDA has completed its evaluation of the Company's corrective actions in response to the December 2019 Warning Letter (defined below). Based on such evaluation, the FDA has determined that it appears that the Company has addressed the violations contained in the December 2019 Warning Letter, and that future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.


Background

As previously disclosed in its Current Reports on Form 8-K filed on December 18, 2019and March 17, 2020, respectively, the Company received, on December 18, 2019, a warning letter from the FDA concerning issues relating to Vaporized Hydrogen Peroxide ('VHP') sterilizers that the Company used as a limited, alternative sterilization method for a small quantity of products (the 'December 2019 Warning Letter'). The warning letter did not question product sterility. In response to the warning letter, the Company noted that it had been planning to decommission and replace the VHP sterilizers, that it had previously procured and validated a new onsite Steris VHP LTS-V sterilization unit, and that it had submitted a premarket notification to the FDA for 510(k) clearance of the new unit. On March 13, 2020, the FDA notified the Company that the FDA cleared the 510(k), allowing the Company to use the new onsite sterilizer. The Company subsequently brought the new unit into service and began processing different product groups over a period of time, decommissioning the existing VHP sterilizers as appropriate.

The information furnished under this Item 7.01 shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the 'Exchange Act'), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as otherwise expressly stated in such filing.