FDA releases draft guidance on microneedling devices

The FDA yesterday released draft guidance covering microneedling devices and what it considers to be a medical device under its purview.

Microneedling devices are often touted as treatments for acne, scars, stretch marks and to generally increase the elasticity and healthiness of skin. The devices and procedures are often meant to be performed at home or in cosmetic or plastic surgery centers.

The federal watchdog laid out a number of treatment claims that, if made, would put such devices under its regulatory jurisdiction. The claims include treating scars, wrinkles and deep facial lines, cellulite and stretch marks, dermatoses, acne, alopecia, stimulating collagen production or angiogensis or promoting wound healing.

The FDA said that microneedling products that are not intended for diagnosing, curing, mitigating, treating or preventing diseases, and those that do not affect the structure or function of the body, do not qualify as a device under its regulation. To meet this, however, the microneedler must not penetrate living skin and can only claim to facilitate exfoliation and produce a luminous or smoother look and feel.

“In general, such microneedling products would not be devices; however, the products may still be subject to other requirements of the FD&C Act or other Federal statutes or regulations administered by other Federal agencies,” the FDA wrote in its draft guidance.

Any microneedling products that meet the agency’s guidelines would be required to be submitted to it for review, the FDA said.

The FDA also warned that such devices are associated with risks including infection, nerve and blood vessel damage, disease transmission between users, scar formation, hyperpigmentation, skin inflammation, allergic reactions and skin irritation.

Earlier this month, the FDA said it is readying a pilot program to try and improve the pre-market approval process for high-risk medical devices later this month.

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