The U.S. FDA draft guidance addressing uncertainty in making benefit-risk determinations for class III devices was well-received by device makers on several points, but there was one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 That theme was an opposition to the draft guidance's default to the use of an FDA advisory committee hearing to address questions about postmarket data collection for devices regulated under the PMA, de novo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.

The med-tech industry turned in a strong stock market performance for the second year in a row in 2018. That's despite the massive retrenchment this quarter in the broader markets, which have fallen into negative territory after soaring earlier in the year. Pharma and biotech stocks also have been hit hard by drug pricing uncertainty and the downside of a long-time frothy market.