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FDA Guidance Offers Clarity on Microneedling Issues

Posted By Administration, Tuesday, November 7, 2017

By Alex R. Thiersch, JD, Founder/Director of the American Med Spa Association (AmSpa)

The question of who can perform microneedling has been a hot-button one in spas and medical spas in recent years. On September 15, 2017, The U.S. Food and Drug Administration (FDA) issued a draft guidance to employees and industry professionals concerning its position on controversies concerning microneedling devices. The document, titled “Regulatory Considerations for Microneedling Devices,” clarifies the rules and offers definitions for a variety of microneedling products. It can be read and downloaded here.

Microneedling—also known as collagen induction therapy—is a skin treatment in which tiny needles are introduced to the skin, penetrating it in order to stimulate the production of collagen and other growth factors. It is relatively inexpensive, usually produces visible results without complications, and is easy to perform, so it has appeal both to medical aesthetic professionals and patients. (See AmSpa’s Treatment Directory for more information on microneedling.)

However, while this treatment is simple, the legal issues surrounding it are not, so it is important to understand why microneedling is such a controversial topic and why this document from the FDA is an important step toward clarity.

The controversy


Treatments that break the outer layer of a patient’s skin typically are considered to be medical in nature. This might seem to intrinsically make microneedling a medical procedure but, in fact, it is very difficult to judge whether or not the skin is being broken when you are dealing with tiny needles that can be as small as fractions of a millimeter long. Skin layer depth varies from patient to patient and depends on the part of the body being treated, as well as the amount of pressure being applied. 

Hypothetically, if microneedling is not a medical procedure, it could be performed by an aesthetician without an exam. However, if it is medical, a patient history must be taken, a licensed medical professional must administer an exam prior to treatment, and proper supervision and/or delegation procedures must be observed during the treatment. Put simply, if microneedling is treated as a medical procedure, it is far less profitable for the medical spa and far less convenient for the patient.

Getting to the point


This draft guidance is a big deal for the medical aesthetic industry. It offers some clarity regarding whether or not the manufacturers of certain microneedling devices need to be compliant with FDA standards, which gives some insight into the current attitudes of the agency and its partners regarding the nature of these treatments.

“Depending on the applicable state laws for scope of practice, delegation and supervision, this could result in medical spas having to reorganize their staffing for the performance of microneedling using newly classified devices,” says Jay D. Reyero, JD, partner at ByrdAdatto. “It could also result in transforming more traditional spas that feature microneedling into what we think of as medical spas.”

We advise everyone who is using microneedling devices at their medical spas to proceed with some caution, because there are FDA issues that are being worked through with regard to compliance. 

“We could see a clear distinction of what constitutes the practice of medicine for purposes of microneedling develop, giving medical spas more clarity on the issue,” Reyero says. “We could envision state licensing boards adopting a position to rely on the FDA’s determination and base a determination of the practice of medicine simply on the type of microneedling product used rather than the particular effects on the human skin or the lengths of needles.”

We anticipate that in the next month or two, the FDA will provide some clarification regarding these issues, but for now, it likely is best to proceed as if these treatments are explicitly medical in nature.

For other medical aesthetic legal questions be sure to seek legal advice from an attorney familiar with aesthetic laws in your state. AmSpaBasic members have access to a 60-question legal summary of regulations in their state, while AmSpaPlus members have access to these answers plus 25 additional questions. Become a member today to get answers to your aesthetic legal questions.

 

 

Tags:  med spa law  microneedling 

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