This past week, the U.S. Food and Drug Administration published draft guidance for its Content of Premarket Submissions for Device Software Functions.
WHY IT MATTERS
The guidance, posted online on November 4, intended to provide information regarding the recommended documentation to include in premarket submissions for the FDA to evaluate the safety and effectiveness of device software functions.
The FDA’s draft recommendations pertain to device software functions – software in a medical device (SiMD) and software as a medical device (SaMD), most notably – and describe data that would be generated and documented during software design, development, verification and validation.
The guidance, once finalized after a public content period, would replace the FDA’s more than…
From: Healthcareitnews.com – Read more
