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.
Get the full story at our sister site, MassDevice.
(And see Snell and other leading minds in medtech live at DeviceTalks Boston on Oct. 2.)