Microneedling is a cosmetic procedure that has been gaining popularity in recent years. It is intended to treat scars, stretch marks, wrinkles, and acne with manual or mechanised microneedles and can be performed at home, in aesthetic clinics, or at plastic surgery centres. The FDA issued draft guidance last week outlining criteria that may place some of these products under the definition of medical devices and therefore required to comply with the associated regulations.
Microneedling devices that meet the definition of medical devices must be submitted to the FDA for review. This would likely need to go through the agency’s de novo pathway as microneedles are currently considered to be a new type of device, therefore not suitable for a 510(k) submission.
Criteria that will determine whether a microneedling device is regulated as a medical device include intended use, manufacturer claims, ease of control by operator, as well as needle length, arrangement, sharpness, and penetration depth. Needles that penetrate into living layers of skin are considered by the FDA to have an “affect on the structure or function of the body”. Claims that meet the definition of a medical device could include:
- Treatment of scars, wrinkles/deep facial lines, cellulite/stretch marks, dermatoses, acne, and/or alopecia
- Stimulation of collagen production or angiogenesis
- Promotion of wound healing
Manufacturers of microneedling devices will need to detail the device’s technical specifications, including needle characteristics and biocompatibility information in order to receive clearance from the FDA. Clinical data to demonstrate safety and effectiveness may also be requested depending on the claims made for the device. Reusable microneedling devices will also need to submit usability testing data, sterilization information and cleaning/disinfection details.