FDA WARNING_LETTER - EnMed MicroAnalytics, Inc. - March 02, 2021

On January 25, 2021, the FDA issued a Warning Letter to EnMed Microanalytics after reviewing their website, https://enmedmicroanalytics.com, on October 8, 2020. The FDA observed the company offering "COVID-19 BLOOD SPOT COLLECTION PACKET" and "SARS-CoV-2 SALIVA RT-PCR TEST COLLECTION PACKET" (Sample Collection Kits) for sale.

These products are considered devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), as they are intended for use in the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. The Sample Collection Kits are being sold and distributed in the United States without marketing approval, clearance, or authorization from the FDA.

Consequently, the products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), due to the lack of approved premarket approval (PMA) applications or investigational device exemption (IDE) applications. Furthermore, the products are misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because the firm failed to notify the agency