Industry Lawyer Outlines Proposal For Device Intended Use Framework

After FDA delayed its controversial intended use rule for a year, one industry attorney is proposing a new intended use framework that would restrict FDA to looking at how a medical device is labeled when determining its marketed intended use. The attorney argues that advertising falls outside of FDA's jurisdiction, and that FDA's past actions surrounding intended use appear to be unlawful under the Administrative Procedure Act, unconstitutional under the First Amendment and interfere with the practice of medicine, he...