COVID-19 Medical Products Supply Chain Week in Review – June 2021 #4

Alston & Bird

Last week, President Biden announced a new milestone of 300 million COVID-19 vaccine doses administered. In addition, the FDA issued a draft guidance to distinguish between “remanufacturing” and “servicing” of medical devices. Please see details for these and other supply chain developments below:

  • On June 17, the White House COVID-19 Response Team announced that more than 175 million Americans had received at least one shot of vaccine, including nearly 2 out of 3 of all adult Americans.
  • On June 17, the White House COVID-19 Response Team announced that the U.S. had started shipping the initial 80 million doses of vaccines to support foreign countries. Mexico and Canada had received doses. 
  • On June 17, the FDA issued Draft Guidance: Remanufacturing of Medical Devices, soliciting public comments until August 17, 2021. The draft guidance intends to clarify the distinction between “remanufacturing” and “servicing” of medical devices, each with different regulatory requirements. The agency also issued a discussion paper outlining cybersecurity challenges and opportunities associated with the servicing of medical devices. 
  • On June 18, President Biden announced that 300 million COVID-19 vaccine doses had been administered in the U.S.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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