• is demonstrated to be at least as safe and effective as the legally marketed device.

Intended use, as defined by regulation (21 CFR 801.4), refers to the intent of persons legally responsible for the labeling. However, this particular definition is not geared to the premarket determination of intended use. It is a postmarket regulation that gives FDA the authority to determine whether someone is distributing a product and promoting it in a way that is consistent with what FDA views as its legal intended use. In the context of a 510(k) submission, when FDA considers issues of intended use, it focuses primarily on indications for use, on whether a product is intended for use by licensed health-care practitioners or laypersons, and on whether the product is intended for single or multiple use. Changes in the indications for use present the biggest regulatory challenges, and the related agency decisions can be the most difficult to explain.

Indications for use is not defined specifically within the confines of 510(k). For PMA, it refers to the disease or condition that a product is used for and the patient population for which the product is intended. For 510(k) devices, indications for use may be functional (that is, what the device does). In the case of very simple devices, such as scalpels, it is not necessary to name all the patient populations or all the diseases and conditions in which the devices may be used. It is not reasonable to describe use to that level.

Two basic changes in indications for use appear in labeling. One is expansion of the patient population. For example, cardiovascular diagnostic catheters may be proposed for use in cardiac ablation procedures. In that case, a cardiovascular mapping catheter that is used for diagnosis is a class II medical device, but the same product promoted and labeled for therapeutic purposes is a class III device subject to PMA requirements.

The other is a change from general to specific indications for use and vice versa. For example, carbon dioxide lasers, which are very old devices that have not changed much from a technologic standpoint, have had considerable changes in indications for use over the years. Carbon dioxide lasers that are labeled for such procedures as photocoagulation, cutting, and ablation of soft tissue are now being proposed specifically for the removal of tattoos. A guidance document available for general and specific intended uses, Phillips noted, outlines the criteria that FDA uses in making a decision about intended use.2

Phillips suggested that the IOM committee consider the following definition to understand FDA’s 510(k) approach to intended use:

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