Medical app regulation has been a rapidly changing field and area of focus for US FDA over the last several years. Most recently, the agency approved the first direct-to-consumer app-based contraceptive, Natural Cycles, from Natural Cycles Nordic AB. (Also see "FDA Approves Birth Control Mobile App, Vaginal Ring " - Medtech Insight, 10 August, 2018.)
Medtech Insight spoke to Marc Scheineson, an attorney and FDA vet who heads Alston & Bird’s food and drug law practice, to get some insight into what the Natural Cycles...