Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Insight, in “There’s a Lot on FDA’s 2020 Guidance Priorities Lists – but the Software Pre-Cert Program Isn’t One of Them,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
Following is an excerpt:
In its annual list of proposed guidances the US Food and Drug Administration’s device center will prioritize over the coming fiscal year, the agency has omitted addressing its ongoing precertification program, which has caught the attention of at least one industry expert.
“Right off the bat, I was hit by the fact that there doesn’t seem to be any mention of guidance related to the precertification program for software, nor with regard to the April concept paper for an approach to artificial intelligence or machine learning,” said Bradley Merrill Thompson, an attorney with Epstein Becker & Green.