In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The guidance represents FDA’s efforts to provide regulatory direction about...more
Last month, the Sixth Circuit affirmed a complete defense verdict for Abbott Laboratories Inc. which was based in part on branded drug preemption. Rheinfrank v. Abbott Laboratories Inc., Case No. 16-3347, 2017 WL 680349 (6th...more
Republican Ann Marie Buerkle was named Acting Chairman of the Consumer Product Safety Commission (CPSC) on February 9, 2017, replacing former Chairman and Democrat Elliott Kaye. This transition has many wondering whether the...more
Last month, in Taylor v. Intuitive Surgical Inc., the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law — the duty to warn hospitals about potential risks their...more
Earlier this month, the Washington Supreme Court saddled medical device manufacturers with a new duty to warn under Washington law—the duty to warn hospitals about potential risks their products may pose—and eroded exemptions...more
The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more
The United States Consumer Product Safety Commission (CPSC) continues to escalate its enforcement efforts. Last week, the United States Department of Justice, on behalf of CPSC, filed suit against Spectrum Brands, Inc....more
6/23/2015
/ Civil Monetary Penalty ,
Consumer Product Safety Act (CPSA) ,
Consumer Product Safety Commission (CPSC) ,
Department of Justice (DOJ) ,
Enforcement ,
Enforcement Actions ,
Manufacturers ,
Notice Requirements ,
Product Defects ,
Product Recalls ,
Spectrum
On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more