Device Lawyer: Guidance Shows FDA OK With More Premarket Risk

A device industry lawyer said a draft guidance FDA issued Sept. 5 shows the agency is willing to accept greater premarket risk in the device development process, as long as postmarket controls and data collection procedures are in place. But while the guidance could help medical device manufacturers get products to market faster, said Bethany Hills, chair of the FDA practice at Mintz Levin, it does not say what FDA or device makers will be required to do if new...