MedCity News June 16, 2022
The nonprofit Digital Medicine Society is partnering with the likes of Google and the FDA to develop a free resource designed to help digital health startups navigate the regulatory process.
A new effort is aimed at helping digital health startups bake regulatory considerations into their business strategy early on – and spare them from nasty surprises when they seek approvals for their products.
By early 2023, the Digital Health Regulatory Pathways project plans to unveil a free, open-access resource that will guide startups along the right regulatory path. Boston-based Digital Medicine Society, or DiMe, is sponsoring the project, which was announced this week.
Regulators have made headway, particularly in the U.S., toward embracing the new generation of digital health...