Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the “Draft Guidances”). The Draft Guidances hit on the topics of in vitro diagnostic (“IVD”) devices, artificial intelligence (“AI”) enabled
Earlier this week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) released its long-anticipated final guidance (the “Guidance”) on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence/machine learning (“AI/ML”) software. FDA’s stated goal for the Guidance is to “to provide a forward-thinking approach to promote the development of safe and
Last month, the U.S. Department of Justice (“DOJ”) quietly updated its March 2023 guidance on the evaluation of corporate compliance programs.[i] Of course, DOJ did not conduct a major rewrite, but interestingly, the updated guidance emphasizes the impact, and evaluation, of emerging technologies on compliance as well as the importance of data when assessing
Yesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and highly controversial – final rule, which rolls out a four-year, five-stage plan that will phase out the Agency’s previous policy of enforcement discretion for Laboratory-Developed Tests (“LDTs”). The final rule was issued at an astonishing speed compared to
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although there was no single moment like the passage of the Affordable Care Act in 2010, there are numerous