There’s No Need To Include Off-Label Use In Labeling, FDA Says In Proposed Rule
After concerns from the medtech industry that a 2017 final rule requires sponsors with knowledge of off-label use of their product to add it to their label, the US FDA is proposing to delete the confusing text.
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The agency has granted a petition from trade groups to delay controversial revisions to its definition of “intended use” for at least one year, and is also gathering comments to guide possible further revisions.
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.
The US FDA’s latest report on non-regulated health and medical software finds they are not associated with any substantial increase in risks, though the agency admits there may be some underreporting.