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 nearly 30 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 provided strategic FDA counsel to many medical device and diagnostic companies, including several first-time entrants to the medical device space, helping them obtain emergency use authorizations from the FDA, and advising them on how to comply with FDA’s pandemic-focused enforcement discretion policies. Michael continues to advise these companies on transitioning to full FDA compliance in the post-pandemic environment.

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.