Lawyer: FDA Digital Health Report Reassuring, But Short On Safety Tips

A medical device industry lawyer said a recent report issued by FDA on digital health tools reassures stakeholders that the agency will not regulate five categories of software which Congress deemed safe when it passed the 21st Century Cures Act in 2016. Some stakeholders had worried that FDA might try to take back jurisdiction over those categories through a clawback provision in Cures. “That's why this report is reassuring,” Brad Thompson, a member of the firm at Epstein Becker Green,...