On September 12, the NAD released its decision in its review of the Capillus82 hair growth device (Case #6107). This case is unusual in that it addressed a challenge to a prescription-only medical device, and related closely to the FDA’s clearance of that product to be marketed. The NAD took pains to emphasize that its decision did not contradict the device’s FDA-cleared indication for use, but did it really?
First, a little background on how the FDA treats medical devices of this kind. Low-to-moderate-risk medical devices may be marketed without preapproval through what is known as the 510(k) clearance process. Instead of being evaluated and approved by the FDA for safety and efficacy, the device can be “cleared” if it is “substantially equivalent” to a device that already is legally marketed. The existing “predicate device” may itself have undergone full approval, or it too may be a 510(k) cleared device pointing to a yet earlier predicate device. The device maker’s 510(k) submission must convince the FDA that the new device is technologically equivalent to the predicate device or is otherwise substantially equivalent in safety and effectiveness. The intended use must be the same as that of the predicate device. The process has been analogized to a generic drug approval predicated on chemical equivalence to an existing branded drug.
The Capillus82 is a hat with 82 laser diodes lining the inside. Its intended use is to treat androgentic alopecia (i.e., slow hair loss) and promote hair regrowth in men and women having certain kinds of pattern baldness. It received FDA 510(k) clearance in January 2017, with the predicate devices being the Hairmax Lasercomb and the iGrow II – no, I am not making these up – which used different form factors to apply laser light to the head, something that apparently promotes hair growth. Clearance was applied for and granted on the basis that the Capillus82’s technology was the same as those of the Lasercomb, iGrow and other laser hair growth treatments, with minor differences that should have no impact on safety or efficacy.