FDA Microneedling Guidance

FDA Microneedling Guidance

FDA microneedling guidance at long last arrived today (Sept. 14, 2018). The Draft Guidance document is available here. Previous posts on microneedling can be found here and here. Only a summary of the microneedling guidance posted today. Below is the constituent update announcing the release.

As expected it appears the FDA will propose a two pronged approach to regulating microneedling devices both as derma rollers and motorized pens. This approach will split microneedling devices into two camps either medical devices or cosmetic. This split will be based both on claims and technology. Based on previous experience with the FDA on these devices the claims likely to qualify as device claims are acne scar revision, tightening wrinkles, and acne treatment. This will be confirmed when the full Guidance is released but follows a familiar pattern where structure/function claims and disease/condition claims are considered device claims. Also, expect any claims about delivering cosmetics or other products deeper into the skin to be included in the device definition. On the technology side, there has been a long and persistent rumor that certain needle depths are cosmetic. This position has never been articulated by the FDA. This may be one of several technological features included in the criteria for distinguishing a device from a cosmetic.

Overall, expect the Guidance even in draft form, to impact imports and listings on Amazon. Watch this space for an update when the guidance is released.

***UPDATE***

Full Guidance now available here. The criteria for a cosmetic device is below and is narrow. Based on the Guidance microneedling devices will need to file for medical device approval.

Microneedling Devices that ARE NOT a Medical Device:

The following are examples of claims associated with microneedling products that meet the device definition:

  • 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 (hair loss)
  • Stimulates collagen production
  • Stimulates angiogenesis
  • Promotes wound healing

In addition to examining a firm’s claims, FDA may consider the design and technological characteristics/features of a microneedling product as a relevant source of information regarding intended use. Specifically, FDA considers needle penetration beyond the stratum corneum as a result of the design or technology of a microneedling product as evidence that it may be intended to “affect the structure or any function of the body.” In considering the design and technology of these products, FDA evaluates the following:

  • Needle length and arrangement and whether the specifications facilitate penetration into living layers of skin
  • Needle sharpness and whether that facilitates penetration into living layers of skin
  • Degree of control of manual or motorized microneedling products over the movement of needles and depth of penetration into living layers of skin

Microneedling products which are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, and which are not intended to affect the structure or any function of the body, are not devices under the FD&C Act. For example, generally, microneedling products that do not penetrate living skin (e.g., epidermal and dermal layers of the skin) and claim only to do the following would not be devices:

  • facilitate exfoliation of the skin (i.e., disruption of the stratum corneum)
  • improvement in the appearance of skin
  • give skin a smoother look and feel
  • give skin a luminous look

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.

Microneedling products have a wide range of intended uses from skin exfoliation and improved skin appearance to the treatment of scars, wrinkles, and other skin conditions (e.g., acne).  This draft guidance provides FDA’s proposed recommendations regarding when a microneedling product meets the definition of a device (section 201(h) of the Federal Food, Drug, and Cosmetic Act). The draft guidance also provides FDA’s proposed clarification on the regulatory pathway to market for microneedling devices.

At this time, there is no existing classification regulation for microneedling devices. However, as outlined in our draft guidance, the FDA believes that these devices may be suitable for De Novo classification.

When determining whether a microneedling product meets the definition of a medical device, the FDA may consider the written or verbal claims in labeling, advertising, or promotions to assess if the product is intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or function of the body.

In addition to considering the manufacturer’s claims, the FDA may consider the design and technological features of a microneedling product.  When examining the design and technology of microneedling products, the FDA evaluates the needle length, needle sharpness, and the degree of control to determine whether these features enable penetration into living layers of the skin.

Microneedling products that are not intended to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or function of the body, are not considered medical devices. For example, microneedling products that act only on the outer dead layer of the skin and are only intended to give skin a smoother look and feel are not devices.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

3 Comments

  1. Eva Carpenter on June 27, 2019 at 9:10 pm

    In Washington state, licensed master estheticians are able to use some medical devices. Do we know if the use of this device needs to be under the authorization or supervision of a physician?
    It’s strange to me that one can perform permanent body modification (tattoos, scarification, permanent make up) with some training and a bloodborn pathogens training, and no state regulated training (source: https://www.dol.wa.gov/business/tattoo/tattoolicense.html). Yet, microneedling is so highly scrutinized?

  2. Chloe on May 14, 2019 at 1:11 pm

    Is there any more update on this?

    As of 2019, I am reading two different claims. Some sources state that ALL microneedling products are now classified as Class II. On the other hand, other sources mention that as long as microneedling products are under 0.3 mm needle length, it’s ok for a home use.

    Which one is correct?

    Thanks

    • Marc Sanchez on May 14, 2019 at 3:53 pm

      Thank you for the comment. The Microneedling Guidance establishes technical and labeling criteria for when a microneedling device is a medical device and when it’s a cosmetic device. There is no mm needle depth set in the Microneedling Guidance but a threshold of going beyond the stratum corneum, which may be why some just throw their hands up and say all microneedling devices are Class II medical devices since penetration beyond the stratum corneum is by design.

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