Minor Cannabinoids: Exploring the Science, Legality, & Opportunities
The Responsible Corporate Officer Doctrine and the Food, Beverage and Agribusiness Industry — What You Need to Know
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
2025 will be a transformational year for the beverage and food industry, which has already been dramatically impacted by shifting market trends and profound policy changes. Here are the top five topics influencing the...more
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issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more
On Friday, December 27, 2024, the Justice Department issued a final rule to address “urgent national security risks posed by access to U.S. sensitive personal and government-related data from countries of concern and covered...more
On December 11, 2024, the Women’s White Collar Defense Association (WWCDA) hosted “Views from the Top,” featuring the following government officials from the DOJ, SEC, CFTC, and FTC discussing current and future enforcement...more
On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more
At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more
...Innovation in connected medical devices is critical to advances in health care outcomes, user experience, and reducing costs. These exciting technologies also can be challenging when it comes to navigating the complex...more
Our downloadable report, Legal Insights for Manufacturing, explores how the business, legal, and regulatory framework is evolving—and will evolve—to address the large generational shifts taking place. This year, our report...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD),” the idea of a defined set of...more
In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program....more
On November 1, 2022, the Centers for Medicare and Medicaid Services (CMS) finalized new policies related to remote therapeutic monitoring (RTM) services reimbursed under the Medicare program. The changes, part of the...more
The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series detailing the history...more
On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more
The Situation: FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided recent clarifications, regulatory questions remain. The...more