QUOTED. Jan. 16, 2019. Bradley Thompson.
Executive Summary
US FDA is taking a cautious approach to rolling out the test phase of its pre-certification program for digital health products to keep it within legal limits. See what Bradley Merrill Thompson, an attorney at Epstein Becker & Green, had to say about the limited scope of the current plan here.
"The pre-certification program would be limited to that 1% of medical devices that are unprecedented. That is a very small slice, and will therefore be of limited interest to the software industry." — Bradley Merrill Thompson, attorney, Epstein Becker & Green
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