The National Law Review

Unpacking Averages: Intended Use Words Most Common to Devices That Require Clinical Trials

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 ...
RAPS

FDA issues proposed rule clarifying stance on intended use

After delaying implementation of parts of its final rule on intended uses multiple times, the US Food and Drug Administration (FDA) on Tuesday proposed a new rule clarifying its position on the types ...
MobiHealthNews

FDA medical app regulation and the art of intended use

With the growth of health apps, entrepreneurs often need to determine if FDA regulates their particular mobile app. As I’ve explained in other posts and indeed in a book, that question has a number of ...
RAPS

Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug ...