SterilMed, Inc. – FDA Warning Letter, May 22, 2012

This FDA Warning Letter, dated October 26, 2011, was issued to SterilMed, Inc. regarding their device, the SterilMed Model 11161M, Modified FemoStop Gold. The FDA determined this product is a device under section 201(h) of the Act. The primary violations identified are that the device is adulterated under section 501(f)(1)(B) because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE) under sections 515(a) or 520(g) respectively. Additionally, the device is misbranded under section 502(o) because SterilMed failed to notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act. The letter emphasizes that for devices requiring PMA, the 510(k) notification is satisfied when a PMA is pending [21 CFR 807.81(b)]. SterilMed is required to take prompt action to correct these violations and notify the FDA in writing within fifteen business days, detailing specific corrective steps, prevention plans, and a timetable for implementation. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contract awards.