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 “Mhealth Advocates Press FDA to Consider Risk in Assessing Apps.” The article also appeared in Inside Health Policy (9/27/11).
Following is an excerpt:
FDA should consider the risk posed by a mobile medical application — and not predominantly its intended use, as proposed by the agency — in deciding how to regulate this technology, mobile health advocates and developers told the agency this week at a public meeting on proposed guidelines for these types of devices. Stakeholders also said FDA should create a new, low-risk category for apps that support medical devices, and the agency should provide more clarity about how it will use its enforcement discretion and how it defines intended use, saying that uncertainty in these areas could stifle innovation of mobile medical applications for smart phones and tablets, especially among developers new to FDA regulations.
Panelists at the FDA workshop said intended use could change depending on who is using the data. There is also a “gray area” in the guidance around some mobile applications for health and wellness, which can help manage specific diseases like diabetes, said Elliot.
The agency should also consider creating a fourth, low-risk level below Class I devices for applications that support a medical device, said Bradley Merrill Thompson. “I would ask you, frankly, to again be creative and not hold the industry to the old intended use standard,” he told FDA officials. “You have the ability through guidance to say ‘we are going to take a risk-based approach and these things are carved out and not regulated.'”