FDA’s enforcement discretion for digital health is more ambiguous than ever in 2021 (MobiHealthNews):
The digital health ecosystem has swelled to encompass a broad range of products over the years.
On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time worrying about oversight from the Federal Trade Commission than the health regulator. [Read more…] about Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA