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Amy Leiser

Special Counsel

San Francisco +1 415 591 7069

  • About
  • Representative Matters
  • Credentials
  • About

    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.

    Areas of Expertise

  • Practices and Industries
  • Representative Matters
    • Advised a leading laboratory trade organization on FDA regulation, including challenge of FDA’s rule seeking to regulate laboratory developed testing services (LDTs) as medical devices.
    • Represented drug and diagnostic companies in negotiation of companion diagnostic development and commercialization agreements.
    • Advised consumer technology company on health product development and FDA regulatory implications.
    • Represented sponsor of drug-device combination product in successfully appealing FDA Complete Response Letter issued on the basis of device review.
    • Advised international medical device manufacturer on establishment of postmarket compliance program.

    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 (2022-2025)
    Previous Experience
    • Merck & Co. Inc., Associate Specialist, Engineering (2012-2013)

    Areas of Expertise

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