Subscribe to Anisa Mohanty's Posts
Anisa Mohanty advises life sciences companies on regulatory, compliance, enforcement, policy, and legislative matters arising under the Federal Food, Drug, and Cosmetic Act (FDCA). She counsels pharmaceutical, medical device, and consumer product companies on premarket pathways, advertising and promotion, and current Good Manufacturing Practice (cGMP) and Quality System requirements. Read Anisa Mohanty's full bio.
FDA Issues Artificial Intelligence/Machine Learning Action Plan
By Vernessa T. Pollard and Anisa Mohanty on Jan 20, 2021
Posted In Big Data
On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan outlines five actions that FDA intends to take to further its oversight of AI/ML-based SaMD: Further develop the proposed regulatory framework, including through draft guidance on a...
Is Your Software a Medical Device? FDA Issues Six Digital Health Guidance Documents
By Anisa Mohanty, Michael W. Ryan and Vernessa T. Pollard on Oct 4, 2019
Posted In General Interest, Mobile Apps
The 21st Century Cures Act, enacted in December 2016, amended the definition of “medical device” in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FDCA) to exclude five distinct categories of software or digital health products. In response, the US Food and Drug Administration (FDA) issued new digital health guidance and revised several pre-existing medical...
Reviewing Key Principles from FDA’s Artificial Intelligence White Paper
By Anisa Mohanty and Vernessa T. Pollard on Aug 28, 2019
Posted In General Interest
In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,” announcing steps to consider a new regulatory framework to promote the development of safe and effective medical devices that use advanced AI algorithms. AI, and specifically...
FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers
By Anisa Mohanty and Vernessa T. Pollard on Jul 24, 2019
Posted In General Interest
As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In...
Order now: The Law of Digital Health Book
By Marshall E. Jackson, Jr., Michael W. Ryan, Ryan S. Higgins, Scott Weinstein, Vanessa K. Burrows, McDermott Will & Emery, Amanda Enyeart, Anisa Mohanty, Amy C. Pimentel, Bernadette M. Broccolo, Dale C. Van Demark, Jiayan Chen and Lisa Mazur on Mar 20, 2018
Posted In Big Data, Cloud, Consumer Protection, Data Privacy, General Interest, Telehealth
Designed to provide business leaders and their key advisors with the knowledge and insight they need to grow and sustain successful digital health initiatives, we are pleased to present The Law of Digital Health, a new book edited and authored by McDermott’s team of distinguished digital health lawyers, and published by AHLA. Visit www.mwe.com/lawofdigitalhealth to order this...