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 ...

Today, we proposed updates to our regulations to clarify the types of evidence the FDA considers when determining the "intended use" of a product. A product's intended use determines whether it is a ...

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 ...

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 ...