Suzanne Forbis Mack

In its latest effort to provide direction and clarity to regulated industry and stakeholders, on September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule and preamble amending its medical product “intended use” regulations “regarding the types of evidence that are relevant in determining a product’s intended uses.” [1] This proposal would repeal and replace portions of the controversial 2017 “final rule” — delayed, in part, based on industry’s concern over FDA’s...

As the world’s health care facilities grapple with the devastating and unexpected operational struggles brought by COVID-19, nursing homes and long-term care facilities face the added challenge of protecting their residents and staff against COVID-19 while under the federal enforcement microscope.

Updated: May 25, 2018: JD Supra is a legal publishing service that connects experts and their content with broader audiences of professionals, journalists and associations.