FDA Refines Requirements For Computer-Aided Detection
This article was originally published in The Gray Sheet
Executive SummaryFDA published two draft guidance documents Oct. 21 to help firms through 510(k) or PMA submissions for computer-aided detection tools; on the following day, the agency announced an upcoming panel meeting on the topic
You may also be interested in...
Two final guidance documents offer some wiggle room for makers of computer-assisted detection devices used in radiology.