Not All Microneedling Products Considered Medical Devices That Are Regulated by the FDA

Posted By American Med Spa Association, Tuesday, September 21, 2021

The FDA regulates microneedling products that are medical devices to make sure they are safe and work as claimed. Not all microneedling products are medical devices.

Microneedling products that are medical devices
The FDA has cleared microneedling devices for use as a treatment to improve the appearance of facial acne scars, facial wrinkles, and abdominal scars in patients aged 22 years or older.

Most of the cleared devices are pen-shaped, motorized and penetrate the skin in order to change the structure or function of the tissue below. Because these devices may reach nerves, blood vessels and other parts of the skin, the FDA recommends you go to a health care provider with special training in microneedling.

The FDA has not authorized any microneedling medical devices for over-the-counter sale.

Microneedling products that are NOT medical devices
Generally, if a microneedling product does not have longer needles or sharp needles that penetrate the skin and only claims to facilitate exfoliation of the skin or improve the appearance of skin, it would not be a medical device regulated by the FDA. A dermal roller with short, blunt needles that only claims to help remove dead skin and smooth and brighten your skin would be an example. These products are more commonly sold for use at home.

Read more at U.S. Food & Drug Administration>>