Heather M. Pearson provides healthcare regulatory counsel on various FDA and life science topics, including medical devices; software as a medical device (SaMD); artificial intelligence and machine learning (AI/ML) in medical devices and products; diagnostic tests; and the regulation of human cells, tissues, and cellular products (HCT/Ps). She also provides transactional counsel as it relates to compliance, operational matters, and mergers and acquisitions in the medical device, healthcare IT, veterinary, and blood and biological product spaces.
Before law school, Heather was a public health analyst at RTI International, focusing on program evaluation and health system financing for the Centers for Medicare & Medicaid Services (CMS). During law school, she summered at the Center for Health Law & Policy Innovation at Harvard Law School and in the Office of the Chief Counsel at the Food & Drug Administration (FDA). Before joining the firm, she served as a term law clerk for the Honorable Damon R. Leichty of the United States District Court for the Northern District of Indiana and the Honorable Carol Hooten of the Minnesota Court of Appeals. Heather earned a law degree from the University of Notre Dame Law School and an undergraduate degree in biomedical anthropology from Wellesley College.
