As the Covington team discussed in a recent article, use of AI models in biopharma is on the rise, with use cases spanning the life cycle of drugs and biologics, including product development, manufacturing, and pharmacovigilance. Recently, FDA announced its own intentions to aggressively scale the use of AI
Continue Reading Could FDA Model Master Files Facilitate Use of Third-Party AI Models in the Drug Life Cycle?
Amy Leiser
Amy advises medical technology and life science companies bringing novel device, digital health and diagnostic solutions to market. She specializes in providing practical advice consistent with the Food, Drug & Cosmetic Act (FDCA), the Clinical Laboratory Improvement Amendments (CLIA), and related state laws to support clients in developing their regulatory and commercial strategies.
Amy counsels clients throughout the product and service lifecycle, from research and development through applicable regulatory authorizations and postmarket compliance. She also frequently supports cross-industry collaborations among pharmaceutical, biotechnology, medical device, clinical laboratory, and traditional technology companies.
Additionally, Amy has supported the day-to-day legal operations of device clients through in-house secondments during periods of transition or particularly high demand on their legal resources.
Amy was named a Rising Star in Food and Drug Law by Washington DC Super Lawyers for 2019-2020 and by Northern California Super Lawyers for 2022-2025. She speaks regularly at conferences on the regulation of devices and diagnostics.
CMS & HHS Health IT Office Issue Request for Information on Digital Health Products and Health Technology Infrastructure
On May 13, 2025, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) announced a request for information seeking stakeholder input on the market of digital…
Continue Reading CMS & HHS Health IT Office Issue Request for Information on Digital Health Products and Health Technology InfrastructureFDA Issues Final Guidance on Multiple Function Digital Health Software and Other Devices
On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software.
The concept of “multiple function” products was introduced by the 21st Century Cures Act…
Continue Reading FDA Issues Final Guidance on Multiple Function Digital Health Software and Other Devices
Client Alert: FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH
The following guidance could be relevant to manufacturers of software as a medical device (SaMD). The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of…
Continue Reading Client Alert: FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH