This message is directed primarily to our overseas readers, and those who represent non-United States drug and medical device companies.  Under FDA registration regulations, non-United States manufacturers (and other regulated companies) that import their regulated products into this country are required to appoint a domestic “agent” for regulatory purposes:

(i) Registration of foreign establishments

(1)

If the promise of adaptive artificial intelligence (sometimes called “Machine Learning”) is to be achieved in the medical area, FDA’s regulation of medical devices is going to have to graduate from geometry to calculus.  By its nature, machine learning changes the details of its output constantly.  The rigid regulatory model requiring FDA pre-approval of all

Today’s guest post, by Luther Munford of Butler Snow, engages in one of our currently favorite activities, that being informed speculation on what might be the consequences of a favorable Supreme Court resolution of its currently pending preemption appeal in Merck Sharp & Dohme Corp. v. Albrecht.  We hope he’s right.  As always, our

We’ve been waiting quite a while for the FDA to modernize its positions on the truthful off-label communications by regulated manufacturers.  Under current First Amendment practice, the FDA’s positions are quite likely unconstitutional as both speaker- and topic-based restrictions on the truthful communication of scientific information.  However, the best we’ve seen from the Agency to

It is now 2019, but we are still finding bits of leftover 2018 business on our desk and in our emails. Towards the end of last year, we encountered an avalanche of good rulings from the Southern District of Indiana in the Cook IVC filters litigation. Here is one we found hidden in the toe

The FDA has recently released a proposed rule “to establish requirements for the medical device De Novo classification process” provided in 21 U.S.C. §360c(f)(2).  FDA, “Medical Device De Novo Classification Process,” 83 Fed. Reg. 63127 (Dec. 7, 2018).  This de novo classification option is a relatively recent addition to the FDCA (via the 1997 FDA

This post comes from the Cozen O’Connor side of the blog.

Today’s story is about a class action, one in which the defendant was sued for labeling its product “No Sugar Added” even though everyone involved, including the plaintiff, understood from the very start that no sugar had been added to the defendant’s product.