COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time.

In Tuesday's Report: FDA explains how EUA medical devices can electronically comply with adverse event reporting rules, claims of meddling in U.S. CDC scientific reports, and other Congressional updates.

Tuesday, 15 September 2020

  • On 9 September, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents,” explaining how a manufacturer distributing medical devices under an EUA or following a COVID-19-related enforcement policy guidance document can satisfy its associated adverse event (AE) reporting obligations. In general, each EUA or device-specific enforcement policy guidance document issued in response to the COVID-19 pandemic specifies the AE reporting requirements for manufacturers, and often user facilities, of the device(s) it covers. These requirements typically follow the standard medical device reporting (MDR) requirements established in 21 CFR Part 803, including the criteria for when an AE or malfunction is reportable and the timelines for reporting. Read more here. (Authored by Michael Heyl and Jodi Scott)

  • The Hogan Lovells Government Relations and Public Affairs group is tracking all of the latest developments in the U.S. Congress and relevant news stories. The House of Representatives returns from recess this week to join the Senate colleagues for the final work period before they adjourn in mid-October for the November elections. President Trump’s appointees interfered with the Centers for Disease Control and Prevention’s (CDC) weekly scientific reports on COVID-19. Reports of the meddling provoked outrage among health experts, Democrats, and some Republicans. Democrats are initiating an investigation into the scope of political interference and demanding that HHS Secretary Alex Azar brief them immediately. HHS Assistant Secretary for Public Affairs Michael Caputo defended his moves claiming that the CDC has a “resistance unit” aimed at undermining Trump. AstraZeneca announced it will resume its coronavirus vaccine trial in the UK, but not in the U.S. after it paused its trials last week when a participant developed a neurological illness. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, warned Americans that they need to prepare for a second wave of COVID-19 infections as flu season approaches. Read about these and other updates online here. (Authored by Ivan Zapien)

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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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