• 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 policy, and federal relations counsel to an array of companies developing a variety of products in the life sciences space, whether traditional medical devices, digital health-based products, biotechnologies, biologic-device combinations, or pharmaceuticals. His primary goal is to bring companies to market and then help them remain there in the most efficient and effective manner possible. 

Working as an extension of each company’s legal and business teams, Michael draws on more than 25 years of experience 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 a physician's office, hospital outpatient or inpatient departments, ambulatory surgical centers or home care. 

During the COVID-19 pandemic, Michael continues to provide strategic FDA counsel to many medical device and diagnostic companies, including several first-time entrants to the medical device space, assisting them in obtaining emergency use authorizations from the FDA, and advising them on how to comply with FDA’s pandemic-focused enforcement discretion policies. 

There are times when federally-regulated life science companies and the patients they serve would benefit from changes to public policy, Michael works with members of Congress and Executive Branch officials to develop, enact and implement these policy changes.

 
  • Obtained release of detained imported VTM test kits intended for use during the COVID-19 pandemic by persuading FDA that the product was eligible for entry under the agency’s enforcement policy.
  • Negotiated a rapid medical device review with the FDA resulting in the clearance of an amendment to a 510(k) and a follow-on Special 510(k) within 80 days of starting the project.
  • Advised clients producing Personal Protective Equipment for use during the COVID-19 pandemic on how to obtain an Emergency Use Authorization or comply with FDA enforcement policies.
  • Negotiated a 510(k) pathway with the FDA for a first of its kind medical device, avoiding the de novo process, and resulting in a 510(k) clearance.
  • Successfully 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.
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Speaker, Health Care Private Equity Basic Training: Digital Health M+A
September 28, 2021
webinar Webinars
September-October 2021
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The Washington Campus MBA Health 3: Strategically Managing Health Care Policy: The Food and Drug Administration: Policy and Process
Presenter
August 17, 2021
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Boost your Medical Technology IQ to Accelerate your Commercial Success, An Introduction to US Medical Device Regulation
Presenter
June 16, 2021
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Boost your BioPharm and Medical Technology IQ to Accelerate your Commercial Success in the US, An Introduction to US Medical Device Regulation
Presenter
May 13, 2021
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Speaker, CSSi LifeSciences and Polsinelli EUA Transition Webinar
April 27, 2021
webinar Webinars
October 29, 2020
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Co-Host, In-House Influence Podcast, Washington, D.C.
December 2020
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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
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