'Least Burdensome' Supersized? Draft Guidance Outlines An Expanded View Of The US FDA Concept
The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.
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FDA explains what qualifies as “the minimum information necessary,” including existing data, peer-reviewed data, and validated computer modeling, for new device and diagnostic applications, in a final “least burdensome” guidance released Feb. 4.
An initial evaluation of US FDA's congressionally mandated staff training programs on "least burdensome" processes are promising, the agency says, but more time is needed to track data on more tangible positive impacts for device companies. Industry, meanwhile, will likely need more convincing.