FDA: Regulators Can’t Scale To Police Mobile Health Apps

The article reports that FDA advisor Bakul Patel said the agency cannot feasibly police the hundreds of new health and wellness mobile apps produced each month and will concentrate regulatory oversight on mobile applications that function as accessories to regulated medical devices or transform phones into regulated devices; it highlights the FDA's risk-based guidance, the short lifecycle of many consumer health apps, and the need to balance safety, security, and usability in medical device design.