Unfortunately, workplace injuries can occur anytime, even when employers take every possible precaution to prevent them. As most employers have experienced, implementing and enforcing safety rules and policies avoids...more
Discovery requests in product liability litigation matters are often a costly and time-consuming black hole. They consume precious resources manufacturers and distributors could use to build up their businesses and, worse,...more
After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more
On April 10, 2020, the Occupational Safety & Health Administration (OSHA) issued interim guidance for the enforcement of employer reporting requirements arising from COVID-19 illnesses that will remain in effect during the...more
In recent years, the U.S. Consumer Product Safety Commission (CPSC) has begun to grapple with the effects of the Internet of Things (IoT) on consumer product safety. In May 2018, the CPSC held its first public hearing...more
The U.S. Consumer Product Safety Commission (CPSC) will host a hearing on May 16, 2018 on potential safety hazards associated with internet-connected consumer products....more
On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products. The FDA had previously issued a Final Rule on...more
The District of Columbia Circuit Court of Appeals recently upheld a Federal Aviation Administration (FAA) decision to publish an airworthiness directive ordering the removal of certain cylinder assemblies used in piston...more
On April 6, 2017, the European Medicines Agency ("EMA") issued new guidance and recommendations concerning periodic safety update reports ("PSURs") of nationally authorized medicinal products. These recommendations form part...more