FDA Spells Out Which Microneedlers Are Medical Devices

Manufacturers of microneedling instruments that go beyond removal of dead skin cells should apply to the FDA for the first-ever marketing authorization of their products as medical devices, the agency says in draft guidance.

The instruments, also known as needlers, dermal rollers or dermal stamps, are not now classified by the FDA under medical device regulations. And if the maker of an instrument claims it does no more than give skin a luminous look or a smoother feel — and the instrument does no more than remove the outer layer of dead skin — than it won’t be subject to those regulations, the FDA says.

But claims to eliminate wrinkles, scars, stretch marks or acne or to stimulate collagen production subject the instrument to regulation as a medical device, as do other claims to affect the structure of the body or to treat disease, the guidance says. Also subject to regulation is any microneedler that penetrates the outer layer of skin to the living cells underneath.

Not covered by the guidance are acupuncture needles, hypodermic needles, tattoo needles or laser and ultrasound needle probes.