Medical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus – FDA Watch
In this first part of our series in collaboration with Covington, Wayne chats with Amy Leiser, Special Counsel at Covington; Scott Danzis, Partner at Covington; and Susan Van Meter, President of the American Clinical Laboratory Association (ACLA). Together, they discuss the history of laboratory developed test (LDT) regulation; ACLA engagement with FDA and Congress on potential diagnostics reform legislation; FDA’s subsequent LDT regulation and ACLA’s decision to initiate litigation; current issues facing laboratories and in vitro diagnostics manufacturers; how the rise of AI is impacting diagnostics; the potential for Congress to reengage on diagnostics regulation moving forward; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Amy Leiser
Amy Leiser 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.
Scott Danzis
Scott Danzis is a partner in Covington’s Food, Drug, and Device Practice Group and chairs the Firm’s Medical Device Industry Group. Scott is a leading expert on the regulation of medical devices, diagnostics, and digital health. He regularly helps clients navigate their most complex regulatory challenges, including strategies for premarket review, postmarket compliance, and enforcement actions. Scott counsels many of the world’s preeminent medical device companies on a range of matters, including advertising and promotion, recalls, quality system issues, medical device reporting, clinical and non-clinical testing, FDA inspections, and other regulatory matters.
Scott previously served in FDA’s Office of the Chief Counsel where he served as the Special Assistant to the Chief Counsel of FDA. At FDA, Scott was involved in a wide range of legal and regulatory matters, including significant rulemaking, enforcement actions, and legislative initiatives.
Scott speaks regularly at conferences regarding FDA regulation of devices and diagnostics, and since 2010 serves as an Adjunct Professor of Law at the Georgetown University Law Center, where he teaches a course on FDA law.
Scott is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of Coif. He also holds a Master’s Degree from George Washington University and a Bachelor of Science from Cornell University.
Susan Van Meter
Susan Van Meter was named ACLA President in March 2022. She previously served as Executive Director of AdvaMedDx where she directed the policy, advocacy, communications, regulatory, payment and legislative strategy and operations of the association, which represents manufacturers of in vitro diagnostic (IVD) clinical tests in the U.S. and abroad. In this role, she also developed the association’s robust response to the COVID-19 pandemic and ongoing advocacy efforts.
Prior to her role at AdvaMedDx, Van Meter served as the Senior Vice President of Federal Relations at the Healthcare Association of New York State (HANYS), where she was responsible for developing their priorities and strategies to further the interests of their hospital and health system members. She also previously worked in the Centers for Medicare & Medicaid Services’ (CMS) Office of Legislation.
Van Meter holds undergraduate and graduate degrees from Villanova University and Boston University, respectively.
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