Medical Device Legal News with Sam Bernstein: Episode 18
JONES DAY PRESENTS®: Harmonizing Global Protections: The EU Trade Secret Directive
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more
This episode, Sam is joined by Sophie Mouros to discuss: a clinical trial fraud case involving allegedly fabricated data, the FDA’s withdrawal from the medical device Global Harmonization Working Party, the FDA’s recent...more
The European Commission adopted Implementing Decisions (EU) 2022/6 of 4 January 2022 and 2022/15 of 6 January 2022 regarding harmonised standards in support of Regulation (EU) 2017/745 (the "Medical Devices Regulation" -...more
The Office of the U.S. Trade Representative (USTR) published a Notice in the Federal Register on Nov. 16, 2021, extending product exclusions for COVID-19-related products covered by USTR's Section 301 investigation into...more
The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020. This is the second delay in the agency's...more
Companies should act now to prepare for the full implementation of the MDR and IVDR. On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current...more
The Food and Drug Administration published a Final Rule in the Federal Register revising labeling regulations for medical devices and certain biological products to allow for the use of symbols without adjacent explanatory...more
This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more