On June 29, 2021, the National Highway Traffic Safety Administration (NHTSA) issued a Standing General Order (SGO) to manufacturers and operators of Automated Driving Systems (ADS) and Level 2 Advanced Driver Assistance...more
Maintaining its focus on breast implant safety, on September 28, 2020, FDA announced the issuance of the final guidance, “Breast Implants— Certain Labeling Recommendations to Improve Patient Communication,” (the “2020 Final...more
In an August 20, 2020, press release, the Food and Drug Administration (FDA) provided an update on the medical device reports (MDRs) received by the agency relating to breast implants, including breast implant-associated...more
The U.S. government has taken several steps in recent weeks to encourage companies to respond rapidly to the COVID-19 pandemic and resulting medical-supply shortage. As discussed here, to assuage concerns about potential...more
Pursuant to the Public Readiness and Emergency Preparedness Act (“PREP Act”), on March 17, 2020, the Secretary of Health and Human Services (“HHS”) published the Declaration Under the Public Readiness and Emergency...more