Want to get a device cleared for market via the US Food and Drug Administration’s breakthrough devices pathway? Then get ready to work closely with the agency during the 60-day review “sprint,” a lead agency official says.
The breakthrough timeline as laid out in statute and followed by agency review teams is tight, said Owen Faris, principal deputy director of the FDA device center’s Office of Product Evaluation and Quality. “We get the request on day zero, then spend the first 30 days conducting a substantive review