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 Guidance 'Consistent' with mHealth Coalition Proposal."
Following is an excerpt:
FDA proposed Tuesday (July 19) to regulate mobile health applications that are used as an accessory to a typical medical device or transform a mobile device into a regulated device, a policy largely in-line with guidance recommendations recently offered by a coalition that includes manufacturers of these products.
Bradley Merrill Thompson, general counsel of the mHealth Regulatory Coalition, said the new FDA guidance document is consistent with the group's proposal to give FDA a limited regulatory scope over these applications.
He added that the new FDA policy will result in few mhealth technologies coming off the market because the agency limited the scope of applications it proposes to regulate. Further, the document will start a dialogue with industry, and encourage investment and development in this area, he said. "I'm pleased because clearly now the discussion can begin," Thompson said.
The group of mhealth technology stakeholders recently drafted a guidance document calling for risk classifications of software applications, with the majority falling under Class I, the lowest risk category (see FDA Week, July 8). However, Thompson said that issue should be addressed by the agency through rulemaking as opposed to guidance. Further, he said the agency should delineate the difference between applications that help manage chronic disease, as opposed to only those that help diagnose and treat disease, as addressed in the agency's guidance.
Overall, he said the new FDA document is consistent with the group's recommendations, including the line drawn between applications that are subject to the regulations and those technologies that would be exempt from FDA oversight. "At a high level I agree with them, but the problem is the devil is in the details," he said.
Thompson noted that there might be confusion about the difference between an application that has an accessory -- such as a blood glucose strip or cuff for measuring blood pressure -- and those mhealth products that do not contain those ancillary accessories but would still be deemed medical devices.
Thompson noted that overall the agency appears "open-minded" in its view of accessories and requested feedback on whether the current scheme of matching accessories with the risk of its product would apply to mobile applications.
