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  • Feature ArticlesFeature Articles

    Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers

    This article summarizes FDA enforcement policy during the early months of the COVID-19 public health emergency and outlines the regulatory considerations for temporary enforcement discretions. The authors emphasize the importance of routine and scientific communication between the FDA, industry, and providers to facilitate the long-term directions of these technologies.   Introduction Historically, the US Food and Drug Administration (FDA) has played an important rol...
  • Feature ArticlesFeature Articles

    Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers

    This article examines regulatory considerations for emergency use authorizations for medical device manufacturers in response to the COVID-19 pandemic. The authors summarize the four phases of issuance as:  phase 1 ‒ in vitro diagnostic products; phase 2 ‒ personal protective equipment; phase 3 ‒ ventilators and components; and phase 4 ‒ other relevant medical devices. They emphasize the EUA is subject to statutory limits tied to the end of the public health emergency and ...