CLOSEOUT LETTER

Boule Medical AB MARCS-CMS 559614 — February 26, 2020

Product:: Medical Devices

Recipient:: Recipient Name

Christina Rubenhag; Recipient Title

Acting Chief Executive Officer; Boule Medical AB; Domnarvsgatan 4
Spanga
163 53 Stockholms Lan
Sweden

Issuing Office:: Office of In Vitro Diagnostics and Radiological Health; United States

Dear Ms. Rubenhag:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS # 559614] dated October 2, 2018. Based on our evaluation, it appears that you have addressed the violations 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/
Courtney H. Lias, Ph.D.
Deputy Director for
Patient Safety and Product Quality
Office of In Vitro Diagnostics and Radiological
Health
Center for Devices and Radiological Health

CC (US Agent):
Deborah A. Herrera
Clinical Diagnostic Solutions, Inc.
1800 NW 65th Avenue
Plantation, Florida 33313