FDA Microneedling Presentation
This past month I joined the American Society for Aesthetic Plastic Surgery (ASAPS) for their annual conference. This year the ASAPS conference was held in Las Vegas Nevada. ASAPS invited me to speak on FDA regulation of microneedling. As I’ve addressed in previous posts and articles there are several questions about the FDA and micro needling.
My goal with the presentation was two-fold. First I wanted to address the question of FDA approval. As microneedling grows in popularity this question is being asked about manual and motorized derma rollers as well. The question comes amid a confusing backdrop of events where Warning Letters and Import Actions cloud the already confusing regulatory landscape. The goal was to clarify key FDA definitions, the regulation of devices, and how both apply to micro needling devices. The second aim was to address rumors about the consequences of using micro needling devices. Some claim users risk jail time, loss of their business or worse. This is misleading and completely wrong. The presentation touched on the practice of medicine doctrine and how FDA jurisdiction is limited to device manufacturers, distributors and the like, not users.
The audience consisted of estheticians, doctors and other skin care professionals. It was a fantastic audience with plenty of questions on cosmetic and device regulation. FDA micro needling regulation is an area filled with misinformation. The ASAPS conference provided an opportunity to set the record straight.
The presentation is linked below. Contact our Washington D.C. or Charlotte, NC office with your microneedling questions.
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[…] The FDA issued a Microneedling Classification Order that will fundamentally reshape how microneedling devices are sold and used. The classification order (link here) was issued in response to a De Novo application submitted by Bellus Medical. The Microneedling Classification Order follows a microneedling guidance issued on Sept. 14, 2018. The Draft Guidance document is available here. (Previous posts on microneedling can be found here and here.) […]
[…] Draft Guidance document is available here.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 […]