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Understanding State Board Regulation of Equipment
By: Susanne S. Warfield
Posted: December 30, 2011, from the January 2012 issue of Skin Inc. magazine.
It has been reported that almost half of all inspections of licensed facilities that occur are initiated through a consumer complaint to the state regulatory board. Skin care professionals who purchase devices from a manufacturer or distributor are often unaware of the regulatory requirements and/or the state board’s lack of understanding of the devices and their uses, which can lead to fines and sanctions. Many of these situations could have been avoided if industry statutes, rules and regulations were current with industry standards, and if the skin care professional had a better understanding of device regulations in order to provide a better defense. It is every licensee’s responsibility to research the technology they purchase and ask better questions of the seller in order to make an informed purchase. Following are the answers to commonly asked questions about esthetic equipment.
Q: Who regulates esthetic equipment?
A: There is no such regulatory language as “esthetic equipment” or “medical equipment.” All equipment is covered under one term: “medical devices.” The U.S. Food and Drug Administration (FDA), Department of Health and Human Services, regulates a broad range of medical devices, including complicated, high-risk medical devices, such as artificial hearts, and relatively simple, low-risk devices, such as tongue depressors, as well as devices that fall somewhere in between, such as sutures. The FDA has the authority to regulate medical devices before and after they reach the marketplace.
Q: Which state board regulates equipment used by estheticians?
A: No state board regulates equipment. Neither the state regulatory board for the skin care industry—often called the cosmetology board or board of professional regulation—nor the medical board regulates equipment. The FDA is solely responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, the Center for Devices and Radiological Health (CDRH) regulates radiation-emitting electronic products, both medical and nonmedical, such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.