Exclusive: Patel Talks Pre-Cert Workshop
US FDA, industry and other stakeholders huddled at NIH for a two-day workshop at the end of January that resulted in deep discussions around how the agency should implement its Pre-Cert Program for software as medical devices. In an exclusive with Medtech Insight, CDRH's Bakul Patel explained the purpose of the confab was to understand how companies realistically operate so they can build the program with those considerations in mind.