FDA WARNING_LETTER - MEDICAMAT S.A. - October 16, 2012

On April 19, 2013, the FDA issued a Warning Letter to MEDICAMAT S.A. following an inspection from October 15-16, 2012, in Malakoff, France. The inspection revealed that the firm's Punch-Hair-Matic-S.A.F.E.R. device, intended for hair loss treatment and thickening, was adulterated and misbranded.

The device was deemed adulterated under section 501(f)(1)(B) of the Act because MEDICAMAT S.A. lacked an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. It was also misbranded under section 502(o) for failure to submit a 510(k) premarket notification. Although registered as a Class I, 510(k)-exempt device (21 CFR 878.4800), its intended use (treating early-stage diffuse hair loss, thickening glabrous skin, eyebrow repair) differed significantly from legally marketed devices under that classification, thus exceeding the exemption limitations.

As a result, the device is subject to refusal of admission into the U.S. under section 801(a) of the Act, leading to "detention without physical examination." The firm must obtain approval or clearance for the device to legally market it.

Additionally, the