Regulation Recap

Posted By American Med Spa Association, Monday, June 15, 2015

By Rob Trow, Dermaconcepts/Environ Skin Care 
The history of cosmetic, medical, and surgical needling in the U.S. and the associated Food and Drug Administration (FDA) rules, regulations, and approval for sale is complex. A cursory review of articles, postings on the Internet, and promotional materials by a myriad of manufacturers can be very misleading or outright false as with many other esthetic technologies.  The purpose of this article is to separate fact from fiction and to provide accurate information for the medical spa industry. Parts of this article have been presented at the Society of Plastic Surgical Skin Care Specialists (SPSSCS) meeting held in May in Montreal and published elsewhere.

The goal of this article is to clarify the following key terms and questions directly related to needling and the FDA. It is important to note that this article only applies to the United States as other countries have taken different positions on skin needling.

Is the device (manual or motorized) cleared for sale and use by the FDA? If you cannot get this in writing on FDA letterhead from the manufacturer or distributor on the specific device, the device is not legal. As one of our presidents used to say “Trust but verify.”
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