Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “FDA’s Mobile App Letter Doesn’t Spell Out Broader Policy.”
Following is an excerpt:
FDA’s first enforcement action against a mobile medical application was significant, but did not give the company a stern warning or create broader mobile health policy in an area where stakeholders are clamoring for clarity, industry sources said following FDA’s recent letter to a company marketing a mobile phone application analyzing urine testing strips.
In a recent and rare “It Has Come To Our Attention Letter,” FDA said Biosense Technologies appeared to be marketing a medical device because its phone app, which analyzes urine testing strips, should be reviewed when used in conjunction with the already cleared testing strips. One industry attorney, who has been pressuring FDA to take enforcement against mhealth companies marketing unapproved devices, welcomed the action.
Bradley Merrill Thompson, general counsel to the mHealth Regulatory Coalition, said the agency took a gentler, more instructive tone than in warning letters. Thompson has singled out the device publicly, including in recent congressional testimony to highlight the need for FDA to take action against mobile apps that are medical devices and should be reviewed by the agency, citing harm to companies that pursue FDA reviews, which drive up development costs.
“I’m all in favor of taking that softer tone but they did need to act,” he said. “They did need to send a letter.” …
“Where it’s clear cut as this case was, FDA should not wait until the guidance is out,” Thompson said, noting there are gray areas that will need to be fleshed out.