US FDA's final guidance last month on when a new 510(k) is warranted for software changes to a medical device is progress, but it still limits the agency's ability to use regulatory discretion, says one industry lobbyist,. That issue, however, may start to be addressed with a new digital health pre-certification program the agency is testing out.
The software guidance is an outgrowth of the broader-based 510(k) modifications guidance, which updated a heavily used 1997 document detailing when companies should file 510(k)s if they make...