• vcard
D 202.772.8496
F 202.783.3535
  • Education
    • J.D., George Washington University Law School, 1986
    • B.A., Franklin & Marshall College, 1983, Government
  • Court Admissions
    • U.S. District Court for the District of Columbia, 1988
    • State of Maryland, 1987
Michael Gaba provides strategic FDA regulatory, Medicare reimbursement, and public policy counsel to medical device and biotech companies. His primary goal is to bring companies to market and then help them remain there in the most efficient, effective manner possible. 

Working as an extension of each company’s legal and business teams, Michael draws on a 20+ year history to navigate the FDA pre-market regulatory pathways, counsel companies on FDA post-market compliance matters, and resolve Medicare coverage, coding, and reimbursement disputes with the Centers for Medicare and Medicaid Services. By using his FDA and CMS experience during the product development phase, Michael is able to help maximize companies’ opportunities to be appropriately compensated in the proper treatment venues, whether it's the physician's office, the hospital outpatient department or home care. 

Recognizing that there are times when federally-regulated life science companies would benefit from changes to public policy, Michael works with members of Congress and Executive Branch officials to help modify or create the necessary policies that not only redound to the benefit of life science companies, but also to the patients they serve.
 
  • Obtained release of detained diagnostic test kit tools from China intended for use during the COVID-19 pandemic by successfully negotiating with the FDA that the product was eligible for entry pursuant to the agency’s enforcement policy.
  • Advised several clients producing Personal Protective Equipment for use during the COVID-19 pandemic on how to do so by either obtaining an Emergency Use Authorization or complying with enforcement policies.
  • Negotiated a 510(k) pathway with the FDA for a first of its kind medical device, avoiding the de novo process, resulting in the company receiving a 510(k) clearance.
  • Appealed an FDA rejection of a clinical trial design for a PMA supplement to enable the medical device company to embark upon its study, leading the FDA to issue guidance to redefine the proper balance between pre-market and post-market data requirements.
  • Resolved a coverage and coding dispute with Medicare contractors to “level the playing field” between competitors in the marketplace, utilizing support from Capitol Hill.
  • Produced appropriate Medicare coverage and reimbursement results by leveraging and explaining FDA requirements to CMS.
  • Counseled a medical device manufacturer on how to become compliant with the FDA’s Quality System Regulation, which resulted in the company being removed from an Import Alert.
  • Advised a biotech company to successfully amend state law to eliminate unnecessary regulation of its customers as tissue banks.
  • Led a team of advocates on behalf of a diagnostics company to successfully modify Medicaid coverage policies in several states.
webinar Webinars
October 29, 2020
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Co-Host, In-House Influence Podcast, Washington, D.C.
2016 - Present
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FDA 101: What Start Ups Should Know About Bringing Med Tech to Market
Speaker, Swissnex Start Up Bootcamp Series
October 15, 2020
eAlerts Updates
October 1, 2020
webinar Webinars
June 3, 2020
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FDA 101: What Inventors Should Know About Bringing Med Tech to Market
Presenter, UT Southwestern Spring Seminar Series on Entrepreneurship
May 14, 2020
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Author, COVID-19 Blog
March 17, 2020
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De Novo Program
Speaker, MDMA's 2020 FDA Forum: PMA/510(k) Workshop, Palo Alto, CA
March 12, 2020
eAlerts Updates
March 4, 2020
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Speaker, ACC National Capital Region
January 9, 2020