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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 2 of 8
Q: Then who tells estheticians what they can and cannot use?
A: Each state regulatory board is responsible for regulating their respective licensees by determining if the intended use of the device is within the licensee’s scope of practice. Review of state law, and the governing rules and regulations provide the framework for the board to make the determination as to whether it decides to allow licensees to use a particular device.
Q: How does the intended use of a device differ when used by an esthetician as opposed to a physician?
A: It doesn’t. If a device is being used for the same intended use for which it was designed, there is no difference. However, if the manufacturer proposes a different intended use for a device that it already has in commercial distribution, the 510(k) regulation specifically requires a 510(k) submission for a major change or modification in intended use. Intended use is indicated by claims made for a device in labeling or advertising. Most, if not all, changes in intended use will require a 510(k).
Q: So, the equipment that estheticians use are in fact medical devices?