On 6/8/2018 the FDA issued a rule regarding the classification of microneedling devices. Per the FDA all microneedling devices are defined as “A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.”

In the original draft guidance document, the FDA clarifies what they consider a “device”, two criteria used are; results claims and how the device is designed. In order for a device to be considered exempt, the results claims must be based on improving the appearance of the skin or facilitating exfoliation only. This does not mean that the device is not regulated and must follow existing law-“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.”

There is a new classification for microneedling devices that place it in Class II with special controls. This means that the manufacturer must file a 510k application and follow the special controls outlined in the rule. Special controls do not mean that the esthetician has to follow a specific process designed by the FDA for use of the device, the manufacturer must meet the requirements before marketing within the US. The esthetician must follow the guidance given by the manufacturer when treating the client which includes aftercare instructions, risks, and benefits, as well as an explanation of the treatment with a recommended course of treatment. The FDA does not designate who can use the device, that is handled by state statute and interpreted by the licensing board (state attorney general).

What does this mean for estheticians?

Many of the devices that have been purchased by estheticians are now considered out of compliance by the FDA. If your state has disallowed Class II devices from your scope of practice, you will not be able to use a microneedling device. If your state has clearly stated no metal needles may be used within your scope of practice this also disallows the use.

The grey area: with many states, there is no designation on devices that are written into rules or statute. This grey area may allow you to work with the device until there is an interpretation from your state board. This is a risk, at a minimum the device you are working with must have FDA approval as of March 1, 2018. If you are operating in a grey area, it is imperative that your liability insurance specifically covers the use of this device and you should be speaking with your provider to clarify what your coverage is. At this point, many policies may not protect you if your device is not FDA registered.

Further clarity is needed on some devices in our profession that are making appearance improvement or exfoliation claims. It is the manufacturer’s responsibility to provide the esthetician with this clarity. If your manufacturer is claiming that they do not need to be registered with the FDA, there must be some proof to back that up.

Esthetics Council Position

It is the position of the Esthetics Council that Class II devices should be allowed within an esthetician’s scope of practice with acceptable training and practical experience. Competency must be proven through testing, and education must be delivered by an instructor who has met the education guidelines identified by the Esthetics Council.  Assessments must include a pre-training clinical test, post-training assessment, and clinical observation of skill. Subjects covered by the training must include disinfection, skin science, practical application, cosmetic chemistry to name a few. To address the need to validate experience and competency, the Esthetics Council has created a verification process for microneedling that any member can access. Guidelines are also available for our state boards to help them fairly regulate this modality as well as understand how it works.

It is a major initiative of the Esthetics Council to get every state in the nation to allow Class II device use with specific training guidelines on modalities that may be considered “advanced”. We do not endorse anyone using a device on a client without proper training, liability insurance, and practical experience.

Medical supervision must be performed by a licensed medical professional allowed to supervise in your state. They must have training on the device and take full responsibility for the protocols performed. When working under supervision, the esthetician is not covered by their liability insurance. Training requirements are the same as working independently.

The Takeaway

  1. Your device must be FDA registered. If a manufacturer claims it does not need to be registered then they must provide proof to back that up. The FDA looks at results claims and device design to determine whether a device needs to be registered.
  2. Microneedling devices are considered a Class II device with special controls.
  3. Claims of penetration of products are not allowed, this is considered transdermal delivery by the FDA.
  4. States regulate the scope of practice, not the FDA. If you are in a “grey area” be prepared to have an interpretation that could disallow this modality.
  5. The position of the Esthetics Council is that Class II devices should be allowed for estheticians if proper training and safety guidelines are followed.
  6. Safety of the client is the first priority, no device should be used on anyone without proper training, liability insurance, and experience.

This is a major setback for our profession, when done correctly microneedling is one of the most effective treatments we have. These devices are available to the public and to limit licensed professionals access to this device is not acceptable. This case is a perfect example of why we must work together to self-regulate our profession in order to avoid the financial trauma and potential harm to clients that can come from devices and modalities that enter our market with no thought to the rules we must follow. The next device on the radar is the plasma or fibroblast therapy. Please be aware that you take a risk by purchasing a device that makes claims that could be interpreted as treating a disease or affecting the function and structure of the skin. At a minimum, those devices must be FDA registered.

References:

FDA Draft Guidance Microneedling

NEW FDA Microneedling Rule