Amy Leiser assists medical device, clinical laboratory, pharmaceutical, and biotechnology clients to operate within a complex, highly regulated area in a way that supports achieving their business goals while minimizing regulatory and litigation risks.

With a focus on medical device, digital health, and diagnostic products and laboratory services, Amy regularly advises clients on a variety of regulatory, legislative, and compliance matters, including under the Federal Food, Drug & Cosmetic Act (FDCA), Clinical Laboratory Improvement Amendments (CLIA), and state clinical laboratory laws.

In her work with both new and established companies, Amy regularly:

• Counsels clients on development and marketing pathways for new products and services, including considerations relating to:     
  • The scope of FDA’s medical device jurisdiction as it relates to digital health tools and laboratory testing services;
  • Issues surrounding classification, clearance, and approval of new devices; and
  • Issues uniquely impacting combination products.

• Assists clients in advocating for legislative and regulatory policies that will support innovation and access to diagnostics and therapeutic products, including by commenting on proposed legislation, rules, and guidance documents.
• Advises clients on compliance with medical device postmarketing requirements, including reporting of medical device reports and corrections & removals.
• Supports clients in responding to domestic and international enforcement actions, including:
  • Providing regulatory support for Department of Justice investigations;
  • Drafting responses to FDA warning letters and international regulatory enforcement letters; and
  • Advising on FDA 483 responses to manufacturing inspection observations.
• Supports life science transactions by:
  • Evaluating regulatory compliance of companies; and
  • Advising on collaboration and commercial agreements, as well as quality agreements that support manufacturing and related services.

Amy has also 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.

Prior to joining Covington, Amy was an Associate Specialist in Engineering within the Merck Manufacturing Development Program at Merck & Co., where she supported vaccine manufacturing operations and clinical trial services.

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 2022-2024.