Michael M. Gaba

Michael M. Gaba


Polsinelli PC

Recognized since 2014

Washington, District of Columbia

Practice Areas

Health Care Law

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Michael M. Gaba is a partner in the Washington, D.C., office of Holland & Knight where he is the federal policy leader of the firm’s national Healthcare & Life Sciences Team. His regulatory and legislative life sciences practice includes counseling and representing medical device and biotech companies before the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the U.S. Congress. Mr. Gaba advises clients on a wide range of regulatory issues related to FDA reform and efficiency, with an emphasis on proper implementation of FDAMA, FDAAA, and FDASIA. He also provides pre-market strategic counseling and post-market surveillance and enforcement advice, with a particular focus on combination product approval, labeling and promotion. Helping clients get to market and stay there, Mr. Gaba counsels medical device and biotech companies on coverage, coding and reimbursement strategies before CMS to enhance patient access to innovative technologies.

Mr. Gaba writes extensively and lectures on a numerous regulatory issues, including comparative effectiveness, interagency coordination and its impact in the post-market context, defending FDA enforcement actions, as well as coverage, coding and reimbursement strategies for medical device manufacturers.

Prior to joining Holland & Knight, Mr. Gaba worked on Capitol Hill in the personal offices of Congressman Robert Garcia (D-NY) and Senator Bill Bradley (D-NJ), and on the Labor and Human Resources Committee for Senator Edward Kennedy (D-MA).

Contact & Links

Location

  • 1401 Eye ("I") Street, NW, Suite 800
    Washington, DC 20005

Bar Admissions

  • Maryland, Maryland State Bar Association
  • District of Columbia, The District of Columbia Bar

Affiliations

  • American Health Lawyers Association - Member
  • District of Columbia Bar Association - Member
  • Maryland Bar Association - Member

Polsinelli PC
Headquarters: Kansas City, Missouri

216 The Best Lawyers in America® awards

90 Best Lawyers: Ones to Watch in America awards

Best Law Firms Badge Full Firm Profile

Recognized in The Best Lawyers in America® 2023 for work in:

  • Health Care Law

Awards:

  • Food & Drug Law Institute, H. Thomas Austern Writing Awards Committee, 2006-2010
  • Bloomberg BNA Medical Devices Law & Industry Report - Advisory Board, 2007-present
  • Food & Drug Law Institute, Food & Drug Law Journal Editorial Advisory Board, 2009-2013
  • Chambers USA – America's Leading Business Lawyers guide, Healthcare: Pharmaceutical/Medical Products Regulatory, 2007-2013

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