Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Science practice, in the Washington, DC, office, appeared in an article about FDA’s mobile apps guidance.
Following is an excerpt:
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.
Thompson added that the new FDA policy will result in few mhealth technologies coming off the market because the agency limited the scope of those 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.
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 requesting feedback on whether the current scheme of matching accessories with the risk of its product would apply to mobile applications.