Bradley Merrill Thompson, a Member of the Firm in the Healthcare and Life Sciences practice, in Washington, DC, office, was quoted in an article titled "New FDA Mobile Apps Guidance Wins Praise."
Following is an excerpt:
The FDA's draft guidance Friday saying it won't regulate devices that transfer, store, convert or display medical data stopped short of excluding from regulation technology that analyzes that data.
But those in the mobile health apps world — who roundly supported FDA's move on so called medical device data systems — said not including analytic devices may not be a bad thing. …
Overall, said Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition, the FDA's carve-out of analyzing devices was "sensible."
"When you analyze data that comes from medical devices, it simply makes sense to treat that in the same way as the device that generates the data," Thompson said. "It is so closely aligned in terms of risk that treating such software the same only makes sense."
