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