Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, D.C. office, was quoted in an article about how a new industry coalition is looking to influence FDA guidance on mobile health technology.
According to the article, a new industry coalition (mHealth Regulatory Coalition) looking to influence FDA guidance on mobile health technology is seeking additional membership from trade associations and patient advocacy groups.
The coalition’s goal is to encourage FDA to develop guidance on mobile health, and to play a role in creating that guidance. The group wants FDA to clear up ambiguity in three key regulatory areas: intended use, medical device connectivity and software applications.
According to Thompson, the coalition wants FDA to consider issues such as the regulatory line between products designed, marketed and distributed for health and wellness versus those used as tools for therapy, diagnosis or disease management; whether every wireless accessory connected to a Class III medical device, such as a cardiac implant, would also be designated as Class III; and when mobile software applications face FDA oversight.
“FDA has kept their mouths shut on software for so long, people are driving without a road map,” Thompson said.
Thompson warned that even if a mobile health device is targeted for consumer or home use, it could still fall under FDA review if the product has applications for disease management.
“It will be important for FDA to understand both the nature of the challenge and also the magnitude,” Thompson said.