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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 4 of 8
Q: What is the meaning of “intended use?”
A: The CDRH’s scientific expertise enables it to exercise considerable discretion in interpreting intended uses in the labeling and promotional materials for predicate and new devices. Thus, a new device with the same intended use as a predicate device may have different specific indication statements and, as long as these label indications do not introduce questions about safety or effectiveness different from those that were posed by the predicate device’s intended use, the new device may be found substantially equivalent.
Although a new device must have the same intended use as a predicate device in order to be substantially equivalent, the FDA does not require that the new device be labeled the same. Label statements may vary. Certain elements of a predicate device’s labeled indication may not be critical to its intended therapeutic, diagnostic, prosthetic or surgical use. For the purposes of determining whether or not the new device has the same intended use as a predicate device, the CDRH assesses any difference in label indications in terms of the safety and effectiveness questions that may arise. The CDRH considers such points as physiological purpose—such as, removes water from blood, transports blood, cuts tissue; condition or disease to be treated or diagnosed; professional or lay use; parts of the body or types of tissue involved; and frequency of use.
Q: Why can an esthetician use a device such as a laser for hair removal in one state and not another?
A: There are a variety of reasons.