August 16, 2010

Comments Submitted to the FDA by the mHealth Regulatory Coalition Regarding FDA Regulations for Mobile Health Devices & Applications

The document presents comments of stakeholders, the mHealth Regulatory Coalition, regarding the U.S. Food and Drug Administration (FDA) plans to regulate communications technologies used as medical devices. The Federal Communications Commission (FCC) and the FDA held a conference to assess stakeholders’ concerns and accepted comments. The FDA and FCC are focused on trends, risk management related to delivery settings and medical-grade wireless technology and communications, and the relationship between FDA approval/clearance and FCC certification of applications, post market, and compliance requirements.