Medical Device Legal News with Sam Bernstein: Episode 11
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
In 1986, from the Invisible Touch album, the rock band Genesis sang a song about “Land of Confusion” (remember the weird video with puppets?). Almost 40 years later, in July 2024, the Food and Drug Administration issued a...more
The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their...more
FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...more
The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
During the COVID-19 public health emergency, the United States Food and Drug Administration (FDA) has issued hundreds of Emergency Use Authorizations (EUAs) and numerous enforcement policies to facilitate the availability of...more
The U.S. Food and Drug Administration (FDA) recently announced its plan to provide medical device manufacturers 180 days to secure marketing authorization or clearance for medical devices that have been marketed under special...more
On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions...more
On September 19, FDA issued a draft guidance that continues its trend to incentivize innovation and increase collaboration with industries in order to expedite the premarket review process, the “Safer Technologies Program for...more
This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more