New regulatory considerations for microneedling devices in the US

The US Food and Drug Administration (FDA) has published a draft guidance explaining when a microneedling product should be considered a device, and should therefore be regulated as one.

By “microneedling product”, FDA means any instrument that includes needles, micro-protrusion, tips or pins that are intended to be applied into the skin.  Depending on their characteristics and/or manufacturer’s claim on the intended use, some products would be considered medical devices.

These include:

  • Treatment of scars, wrinkles, deep facial lines, cellulite, stretch marks, dermatoses, acne or alopecia
  • Simulation of collagen production
  • Simulation of angiogenesis
  • Promotion of wound healing
  • Products where the needles penetrates beyond the stratum corneum.   In this purpose, the length, sharpness, arrangement and movement control should be taken into consideration.

As there is currently no microneedling device registered in the US, manufacturers should follow the De Novo classification process and request FDA to classify the device under class I or II.

The application should include necessary information to demonstrate assurance of safety and effectiveness of the device.  This includes, for example, needle characteristics, biocompatibility, usability testing, sterilisation/disinfection, and clinical data if necessary.

FDA considers that the following risks should be addressed: infection, nerve and blood vessel damage, disease transmission between users, scar formation, hyperpigmentation, skin inflammation, allergic reactions and skin irritation.

Once a De Novo request is granted for a microneedling device, this device will serve as predicate for future devices.

To read the guideline, please click here.