Ana Loloei Marsal

Ana Loloei provides counsel to clients regarding issues associated with medical devices, in vitro diagnostics, and combination products on a broad range of matters under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Ana leverages her extensive experience and familiarity with these types of technologies, acquired during her tenure at the Food and Drug Administration (FDA) in various roles, to guide clients through complex premarket and postmarket regulatory requirements and to assist with the management of total product life-cycle matters.  Ana’s deep knowledge includes the requirements for advertising and promotion of FDA-regulated products, and she advises clients on matters regarding product marketing, labeling, promotion, and advertising.

Prior to joining the firm, Ana served in various roles at FDA for nearly 14 years, including as a Senior Policy Advisor in FDA’s Center for Devices and Radiological Health (CDRH) and as a Special Advisor in the Office of the Commissioner.  Most recently Ana served as a Senior Regulatory Counsel in the Office of Policy at CDRH, where she tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products, including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions.  During her tenure at FDA, Ana also worked closely with Congress, the Department of Health and Human Services, the National Institutes of Health (NIH), and the Centers for Medicare & Medicaid Services (CMS) on the development of numerous guidance documents, rulemakings, and policy and legislative initiatives.

Prior to entering the legal field, Ana served as a biomedical/electrical engineer at an engineering firm involved in the design and development of radio frequency (RF) distribution systems from initial market and data preparation through testing and troubleshooting of these products.