FDA’s enforcement discretion for digital health is more ambiguous than ever in 2021 (MobiHealthNews):
… Read the restThe 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.
However, a growing number of companies are finding themselves in a gray area of enforcement discretion, a term the FDA uses for lower-risk products that meet the definition of a medical device, but do not require regulatory submission, review and authorization before heading to market … Early-stage companies that haven’t yet internalized these concepts of documentation and transparency should take an “engage early and