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Despite 510(k) Software Guidance, US FDA's Hands May Still Be Tied

While a recent final guidance when a 510(k) is needed for software changes is helpful, a key industry lobbyist says it doesn't do enough to address the bigger issue of allowing FDA more discretion to let software medical device-makers update their products quickly without burdensome agency oversight.

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...

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