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Amy Leiser

Special Counsel

San Francisco +1 415 591 7069

  • About
  • Representative Matters
  • Credentials
  • About

    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.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Assisted a leading laboratory trade organization in developing comments on legislative proposals for diagnostic reform and FDA proposed rulemaking to regulate laboratory-developed tests (LDTs).
    • Represented drug company in negotiation of companion diagnostic development and commercialization agreement.
    • Represented sponsors of device and combination products in appealing FDA review decisions, including drafting requests for internal review and preparation for formal meetings with FDA.
    • Advised companies on regulation of digital health products, including software functions regulated as medical devices by FDA.
    • Advised an international medical device manufacturer on development of procedures to facilitate complaint handling and adverse event reporting.
    • Coordinated international surveys to support global marketing and distribution plans for medical device companies.
    • Drafted requests for designation (RFD) for new products at the boundaries of FDA’s drug and device jurisdictions.
    • Prepared and conducted trainings for in-house attorneys on several topics, including:
      • Regulation of medical devices and non-device digital health products;
      • Regulation of diagnostics and companion diagnostics; and
      • Requirements and best practices for complaint handling and medical device reporting.

    Areas of Expertise

  • Credentials
    Education
    • Georgetown University Law Center, J.D., 2016
        • Order of the Coif
        • magna cum laude
        • Georgetown Law Journal, Communications Editor
        • ABA/BNA Award for Excellence in Health Care Law
    • University of Texas, B.S., 2012
        • Human Biology (Genetics and Biotechnology)
        • Highest Honors
        • Phi Beta Kappa
    Bar Admissions
    • California
    Pro Bono
    • Represented Federally Qualified Health Center (FQHC) in preparing public comments concerning FDA blood donation guidelines.
    • Advised non-profit organization on redistricting laws and procedures in various states.
    • Conducted survey of state Medicaid and prescriptive authority laws for health care non-profit.
    • Represented national advocacy organization in judicial vetting matter.
    • Represented individual seeking criminal record expunction in Maryland.
    • Advised DC arts non-profit on corporate compliance.
    Accolades
    • Washington DC Super Lawyers Rising Star, Food and Drug (2019-2020)
    • Northern California Super Lawyers Rising Star, Food and Drug (2022-2024)
    Previous Experience
    • Merck & Co. Inc., Associate Specialist, Engineering (2012-2013)

    Areas of Expertise

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