Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in TechCrunch, in “Don’t Wait for the Apple Watch to Dole Out Medical Advice Anytime Soon,” by Sarah Buhr.
Following is an excerpt:
Combined, the efforts certainly suggest that Apple has bigger plans for its Watch than meet the eye. Still, users might not want to hold their breath, for a few reasons.
The first is the way that the FDA classifies medical devices, which involves regulatory hoops that Apple might not want to jump through. As regulatory attorney Bradley Merrill Thompson explains it, it’s Apple’s “software app that will be the ‘FDA-regulated medical device,’ not the hardware watch.
“The FDA only regulates specialized medical hardware and software,” he continues, “so if Apple adds hardware specific to glucose monitoring, that would be regulated. And any software they add specific to the medical functionality would be regulated. But the general-purpose platform would likely not.”
Put another way, Apple would need to avoid making medical claims specific to the platform, and instead limit its medical claims to the specific software and hardware dedicated to a particular medical purpose, Thompson says.
