Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was featured in Medtech Insight Pharma Intelligence, in “Quoted,” on the topic of the FDA’s pre-certification program for digital health products.
Following is an excerpt:
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.”