The Secretary of HHS issued a public health emergency declaration, effective February 4, 2020, regarding COVID-19. The impact of that declaration is to trigger certain targeted liability immunity provisions under the Public Readiness and Emergency Preparedness Act (PREP Act). Under those provisions, qualified pandemic products are “immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure if a Declaration has been issued with respect to such countermeasure.” PREP Act liability immunity is not dependent on other emergency declarations; however, products that are not currently approved or cleared or that are seeking label expansions still have to go through the regulatory process in order to fit within the PREP Act provisions.