Between the consequences of Brexit and a new commissioner at the FDA, executives across medtech are bracing for change within the global regulatory landscape. NxStage Medical‘s (NSDQ:NXTM) SVP of quality assurance, regulatory & clinical affairs, Todd Snell, spoke with MassDevice.com editor Sarah Faulkner about what he’s observing from his post at the Lawrence, Mass.-based company.
Faulkner: What has caught your eye from Scott Gottlieb’s first moves as head of the FDA?
Snell: I’m finding that there’s a real speed to FDA establishing alternative pathways for regulating software. In the past two weeks, FDA announced a program where companies can be part of a pilot where, if their inspection history and submission history is strong, the FDA may ‘pre-certify’ companies.
The intent here is to de-risk certain types of medical device software and hopefully provide a less burdensome pathway. I feel that’s a positive step out of the gate.