FDA Steps in to Regulate Microneedling Devices

Regulatory NewsRegulatory News | 14 September 2017 |  By 

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance detailing when it considers "microneedling" products to be medical devices and subject to regulation.

In recent years microneedling has emerged as a trendy cosmetic procedure often advertised as a minimally invasive option for treating scars, wrinkles, acne and stretch marks, and is often performed at home or at plastic surgery centers.

A quick Google search reveals product listings for mechanized and manual microneedling products for sale at major retailers including WalMart and Amazon, as well as numerous clinics advertising microneedling procedures.

But in its draft guidance, FDA says that many microneedling products meet the definition of a medical device and must be submitted to the agency for review. FDA also says the devices are associated with a number of risks, including infection, nerve and blood vessel damage, disease transmission, scarring and allergic reactions.

Whether such products are devices largely falls on their intended use and the manufacturer's claims. Specific claims that would meet the definition of a medical device include:

  • Treats scars (e.g., acne scars, atrophic scars, hypertrophic scars, burn scars)
  • Treats wrinkles and deep facial lines
  • Treats cellulite and stretch marks
  • Treats dermatoses
  • Treats acne
  • Treats alopecia
  • Stimulates collagen production
  • Stimulates angiogenesis
  • Promotes wound healing

Additionally, FDA says the depth the needles penetrate the skin will factor into the determination, as the agency views needles that penetrate into living layers of skin as having an "affect [on] the structure or function of the body."

Here, FDA says the length, arrangement and sharpness of the needles are key factors to consider, as well as how much control the operator has on the needles' movement and depth of penetration.

Manufacturers looking to market microneedling products that meet FDA's definition of a device will likely need to look to FDA's de novo pathway, as FDA considers microneedling devices to be a new type of device not suitable for a 510(k), though once a device is classified others may use it as a predicate.

In order to receive clearance, FDA says manufacturers will need to detail the technical specifications of their device, including its needle characteristics and biocompatibility information and will need to usability testing data, sterilization information and cleaning/disinfection details if the device is reusable.

And depending on the manufacturer's claims, FDA says clinical data may be necessary to demonstrate safety and effectiveness.

FDA draft guidance on microneedling


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