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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.
page 3 of 8
A: Yes. Once the FDA started to regulate all devices sold in the United States, this is the correct terminology to describe the equipment that is used by skin care professionals. The galvanic and the high frequency machines that estheticians use have been around long before the FDA began regulating medical devices. Medical devices are classified as Class I, II and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. For example, Class I includes some microdermabrasion devices; Class II includes some intense pulsed light (IPL) and ultrasound devices; and Class III includes some laser devices.
Q: How does the FDA determine safety of these medical devices?
A: It doesn’t. Standards are met by the manufacturer of the device and submitted to the FDA in the form of a 510(k) Summary of Safety and Effectiveness. The device’s summary includes the submitter’s information, device information, predicate devices, intended use, device description, performance and clinical data, and substantial equivalence. Upon review by the FDA, the device may be given approval to go to market, subject to the general control provisions of the Federal Food, Drug and Cosmetic Act. These provisions include requirements for annual registration, listing of the device, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Q: Where do lasers and light devices stand—are they medical devices?
A: Yes. The FDA has classified and described more than 1,700 distinct types of devices and organized them in the Code of Federal Regulations (CFR) into 16 medical specialty panels, such as cardiovascular devices, or ear, nose, and throat devices. Laser and light therapy devices fall under the classification name: laser surgical instrument for use in general and plastic surgery and dermatology. Device classification depends on the intended use of the device, and also upon indications for use and information about marketing requirements.