FDA to Block Imports of French Company's Hair Loss Prevention Device
The Food and Drug Administration said it will refuse imports of MEDICAMAT S.A.’s “Punch-Hair-Matic-Suction Assisted Follicular Extraction and Re-implantation” device, after discovering that the device is intended for unregistered uses and is not covered by a premarket approval or investigational device exemption for those uses.
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The French company had registered and listed the product as a Class I “manual surgical instrument for general use” device, intended to automate hair transplant for the surgical treatment of baldness. Instead, the Punch-Hair-Matic S.A.F.E.R. device is indicated to treat the first stages of male and female diffuse hairloss, as well as thickening of the glabrous skin and eyebrow repair, FDA said.
Because the device exceeds the limitations on manual surgical instruments for general use, it is not exempt from premarket notification requirements. MEDICAMAT doesn’t have a PMA or IDE for the device, so FDA said it is placing the devices on detention without physical examination until the violations are corrected.