There is tremendous speculation in Arizona about microneelding regulation. This speculation was further exasturbated by a legislative update the ASCP released on 10/1/18. Associated Skin Care Professionals informed it’s members that the FDA classified microneelding devices on June 8th, 2018. You can find the FDA publication here.
Microneedling IS legal in the state of Arizona. Here is what you need to know.
There are two agencies that make laws dictating your aesthetics practice, the Food and Drug Administration and the Arizona State Board of Cosmetology. The FDA is a federal governing body, the AZBOC is a state governing body. Each state has different laws, but federal laws apply to everyone. (Laser certifications are governed by another state agency. Nurses and physicians have different regulatory boards).
Arizona State Law
Currently the Arizona State Board of Cosmetology does not regulate microneedling. If a procedure is not regulated, meaning there are no laws to govern it, anyone can perform it. After speaking with the AZBOC staff extensively, many times, they have advised aestheticians to ‘post out’. Posting out means you post a sign that states the AZBOC does not regulate microneedling. You cannot use your aesthetics license to validate that you are equipt, trained or regulated by the AZBOC to perform microneedling. I requested the lack of microneedling regulation to be given to me in writing and they declined. Posting out is effective in protecting yourself from AZBOC citations, as I (and many of my colleagues) post out and have never been cited by the AZBOC.
‘Posting out’ also applies to other aesthetic treatments not regulated by the AZBOC: permanent makeup and plasma fibroblast skin tightening.
The ASCP article suggests that if your state allows microneedling and the use of a registered class II medical device, then “you should be able to use that device in your practice, provided you have adequate training”.
What does the FDA do? As it pertains to our industry, the FDA regulates the use of “biological products and medical devices intended for human use are safe and effective”. The FDA concerns itself with microneelding manufactures and the claims they make.
Microneedling first came onto the medical aesthetics scene back in the mid 90’s. In the years following, many advances were made in technique, research and quality of devices. During this time, microneedling devices were not classified by the FDA and fell into the De Nova loophole of classification.
On September 17th, 2017 the FDA published a draft guidance for regulatory considerations of microneedling devices. Then, on June 8th, 2018 the FDA classified microneedling devices as a class II medical device. This classification came after Bellus Medical (Skin Pen) first applied for classification with the FDA.
Arizona Aestheticans still fall into a loophole. Microneedling is not regulated, so we can legally perform the treatment in our state, as long as we are not performing the treatment “under” our license. However, I cannot stress enough the importance of quality training. Micorneedling is a medical aesthetics treatment and comprehensive training will keep you and your clients safe. Your training should include: scientific data supporting the protocols taught, throughly explain why bleeding is not the clinical endpoint (as many of our colleagues believe) and discuss the appropriate language used in marketing and what type of devices you can use, to keep you within FDA scope.
Acquiring adequate liability insurance and quality microneedling supplies is another integral part of a safe microeedling treatment. The ASCP now offers microneedling coverage, as an advanced modality. I also recommend City Scape Insurance. They are an Arizona company and will walk you through the insurance process, providing excellent customer service and coverage for advanced modalities like microneedling, plasma fibroblast and permanent makeup.