Certify Global Inc.

CLOSEOUT LETTER Certify Global Inc. MARCS-CMS 613568 — December 13, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Marc Potash Certify Global Inc. 9801 Washingtonian Boulevard Suite 200 Gaithersburg , MD 20878 United States marc.potash@certifyglobal.com Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Marc Potash: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 613568, dated March 4, 2021. 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. Sincerely, /S/ Kellie B. Kelm, Ph.D. Acting Office Director OHT 3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 12/17/2024 Regulated Product(s) Medical Devices