pharmaphorum January 18, 2021
Developers of digital health tools have benefited from a truncated route to market during the COVID-19 crisis, and that could be made permanent if new FDA guidance is adopted.
Pandemic emergency provisions were put in place in March last year to allow certain medical devices to be launched for use by patients without having to go through the FDA’s usual premarket notification requirements – also known as the 510(k) process.
That included some low-risk (Class IIa) digital health apps under the software as a medical device (SaMD) category, which can be used to minimise direct contact between patients and healthcare professionals at a time when non-essential visits are best avoided.
Now, the FDA is seeking comment on plans to make...