Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences Practice in the firm’s Washington, DC office, was interviewed for an article about how the Food & Drug Administration (FDA) may move to regulate wireless health technology.
The article, “When will the FDA drop the gavel?” stated that although the FDA had, in February, begun to discuss with the mobile health industry ways in which the agency might impose regulations, it remains unclear nine months later what the FDA may propose.
Thompson outlined how the FDA might regulate wireless health under its existing system, noting that the agency regulates only actual products, such as medical devices, rather than intangibles, such as medical procedures. Software can be a medical device if it’s written on computer media, as opposed to printed on paper. The media with the code written on it is enough of a ‘thing’ for FDA to regulate, he said.
“In the area of mobile health technology, it’s important to understand that an accessory or a component of a medical device is itself a regulated medical device,” he said. “Further, the difference between an accessory and a component is who buys it. End-users buy accessories, while manufacturers buy components. Thus, the exact same piece of equipment could be either an accessory or a component depending on the target purchaser.”