“Intended use” is perhaps one of the most important concepts in FDA law. It is significant in two ways. First, a product’s intended use can dictate whether it is even subject to regulation by FDA, and ...
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, 1 marking the end of an effort ...
In November 2014, the Pennsylvania Supreme Court issued its landmark opinion in . Among other things, the court held that a plaintiff can satisfy the "defective condition" element of her products ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Regulatory Fate of a New IVD May Well Depend on a Few Dozen Words In vitro diagnostic (IVD) devices are comprehensively regulated by the FDA. The FDA, however, does not regulate just the physical ...
We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
The FDA has posted a final rule for its intended use policy for devices, drugs and biologics, which formalizes the elimination of the totality-of-the-evidence approach to determining the ...
Device makers will want to be aware of one sentence omitted from a proposed rule about tobacco products. Marie Thibault Unsurprisingly, MD+DI focuses mainly on medical devices and diagnostics. So it ...
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