Medical Device Legal News with Sam Bernstein: Episode 11
Over the last few years, the Federal Risk and Authorization Management Program (“FedRAMP”) Program Management Office (“PMO”) has released two draft guidance documents related to defining the applicable boundary for security...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations and...more
The U.S. Food and Drug Administration (FDA) recently published revisions to its multichapter draft guidance for industry on Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food (the Draft Guidance). 89...more
After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more
In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more
DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more
In the medical device industry, there exists a longstanding divide between device manufacturers (i.e., those who design, manufacture, fabricate, or process a finished device) and the third-party entities that service the...more
On November 23, 2021, the Massachusetts Cannabis Control Commission (CCC) released Draft Guidance on Hemp (Draft Guidance). Pursuant to a 2020 amendment, adult-use cannabis establishments licensed by the CCC are permitted...more
The European Commission announced on 22 January 2020 that it is looking for feedback on draft guidelines on the implementation of Article 4 of the Market Surveillance Regulation (EU) 2019/1020 (the "Regulation"). ...more
In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more
On September 26, 2019, FDA released a suite of revised digital health guidances, which includes the following: - Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act...more
• The FDA recently issued six guidance documents that further clarify the agency’s interpretation of the 21st Century Cures Act’s software exemptions. • The revised draft guidance on CDS further elaborates on how to make CDS...more
The U.S. Food and Drug Administration (FDA) continues advancing regulatory policies tailored to the digital health community. On September 26, 2019, the agency issued a series of guidance documents that interpret several of...more
Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more
The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule....more
On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market....more
On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more
Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more
Seyfarth Synopsis: In compliance with the New York State Anti-Sexual Harassment legislation passed earlier this year, the Office of Governor Andrew M. Cuomo has released drafts of the model sexual harassment policy, training...more