A week after the Congressional hearings discussed how the US Food and Drug Administration’s impending regulatory guidelines (expected by October) will impact mobile health apps, aspiring and current digital health entrepreneurs may be rethinking their path. In a report dubbed “FDA 101,” health startup accelerator Rock Health has compiled a handy report to help digital health entrepreneurs assess whether their mobile health apps would be classified as medical devices by the FDA and require 510(k) clearance.
To read the full, original article click on this link: Does your mobile health app need FDA clearance? Checklist gives guidance for digital health entrepreneurs | MedCity News
