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'Least Burdensome' Supersized? Draft Guidance Outlines An Expanded View Of The US FDA Concept

Executive Summary

The US agency issued a draft guidance that brings the 20-year old concept of "least burdensome" in medical device regulation to all corners of the device center's activities.

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US FDA Emphasizes Computer Modeling, Existing Data For Least-Burdensome Device Submissions

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.

Early Signs Positive From FDA's Least-Burdensome Training

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.

FDA Sends Record-Low Warning Letters To Device-Makers In 2017 As Agency Takes More Personalized Compliance, Enforcement Tack

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