Medical Device Legal News with Sam Bernstein: Episode 11
As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations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
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more
Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more
During the ongoing COVID-19 pandemic, the Center for Devices and Radiological Health (CDRH) in the U.S. Food and Drug Administration (FDA or the Agency) issued a series of Emergency Use Authorizations (EUAs) and guidance...more
Food/Dietary Supplements - FDA Calls for Improved Practices in the Papaya Industry – The FDA reported trends in outbreaks of Salmonella in fresh papaya. ...more
On May 30, 2018, the U.S. Food and Drug Administration launched an innovation challenge as a way to combat the fight against opioid addiction. The challenge was issued to “spur the development of medical devices, including...more
On December 11, 2017, the Food and Drug Administration (FDA) issued a guidance entitled, Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements. The guidance clarifies the requirements for...more