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COVID-19: FDA Withdraws Guidance, Ends Surgical Mask EUA

The Food and Drug Administration (FDA) announced on March 10 plans to withdraw several COVID-19 guidance documents, most of which were set to remain effective only for the duration of the COVID-19 public health emergency (PHE) declaration, which ends May 11.

Withdrawn guidance includes:

  • Policies that allowed outsourcing facilities and pharmacies to compound certain drugs used to treat patients hospitalized with COVID-19.
  • Exemptions and exclusions from certain requirements of the Drug Supply Chain Security Act.
  • Temporary Prescription Drug Marketing Act requirements.

To provide a transition period for stakeholders, the agency also designated certain policies, mostly regarding device enforcement, to expire 180 days after the PHE ends, on Nov. 7.

The future of additional guidance documents regarding emergency use authorizations (EUAs) for COVID-19 vaccines; the development of monoclonal antibody products that target SARS-CoV-2, the virus that causes COVID-19; and the enforcement of face masks and other barrier face coverings, among others, remains unclear. These policies will remain in effect for 180 days following the termination of the PHE but also face possible revision.

The agency states that the withdrawal and revision of COVID-19 policies reflect the changed circumstances surrounding COVID-19.

FDA No Longer Authorizing Surgical Masks under Umbrella EUA

Ahead of the PHE ending, the agency also announced March 6 it no longer will authorize disposable surgical masks under its umbrella EUA policy, first established in August 2020.

The revision authorizes emergency use of only those surgical masks listed in the EUA’s Appendix A as of March 6, and no additional surgical masks will be added to Appendix A.

The FDA says the decision was based on the totality of scientific evidence available, including information regarding supply, demand, and distribution, as well as information compiled from requests for additions of surgical masks to Appendix A.

The agency also urges manufacturers seeking to introduce new surgical masks to the market to follow traditional premarket pathways, such as a premarket notification, or 510(k).

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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