In response to the Coronavirus Disease-2019 (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) used its emergency authority through Emergency Use Authorizations (EUAs) to make COVID-19 in vitro diagnostic tests widely available to both diagnose active infection and help identify individuals with an adaptive immune response indicating recent or prior infection. Hundreds of innovative tests were quickly developed under Section IV.D. of FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019. National reimbursement guidance through Centers for Medicare & Medicaid Services (CMS) provided significant financial incentives to track the endemic and enable healthcare workers and others get back to work more quickly. The US market for tests grew rapidly and the now exceeds $15 billion. However, many issues regarding product quality and availability have plagued the industry and called into question FDA’s policy and regulatory framework for allowing these tests to be commercially available. This paper analyzes the development of COVID-19 in vitro assays and the lessons learned for innovation during a public health crisis.
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