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Amy Leiser

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.

Contact:Read more about Amy LeiserEmail

On January 19, 2018, FDA announced the availability of a new draft guidance, titled “Material Threat Medical Countermeasure Priority Review Vouchers.” FDA’s publication of the draft guidance, which was issued by FDA’s Office of Counterterrorism and Emerging Threats (OCET) without a statutory mandate – reflects the commitment of FDA leadership to the development and approval of medical countermeasures (MCMs). In a question and answer format, FDA provides details about the Agency’s interpretation and implementation of the MCM priority review voucher (PRV) program, which was established in December 2016 by the 21st Century Cures Act (Section 565A of the Federal Food Drug, and Cosmetic Act (FD&C Act)). That provision, intended to incentivize the development of MCMs, requires FDA to award a PRV to the sponsor of a successful marketing application that meets certain statutory criteria.
Continue Reading FDA Commitment to MCM Development Reflected in New Draft Guidance on Medical Countermeasure Priority Review Vouchers