The U.S. FDA draft guidance addressing uncertainty in making benefit-risk determinations for class III devices was well-received by device makers on several points, but there was one recurring theme in the comments to the docket. That theme was an opposition to the draft guidance's default to the use of an FDA advisory committee hearing to address questions about postmarket data collection for devices regulated under the PMA, de novo and humanitarian exemption programs, a provision that, if sustained, could create considerable uncertainty regarding a device's place on the market. Read More
