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FDA Updates Convalescent Plasma Guidelines to Announce Temporary Enforcement Discretion for Testing

FDA maze of regulations

Updates to FDA guidelines include enforcement discretion, allowing three months of testing flexibility for convalescent plasma as laboratories develop collection procedures

On Sept. 2, 2020, the US Food and Drug Administration (FDA) announced updates to initial convalescent plasma guidelines that became available when the emergency use authorization (EUA) for convalescent plasma was first announced. These guidelines detail temporary enforcement discretion addressing convalescent plasma that was collected prior to the issuance of the EUA. Also addressed with the update is the collection of plasma by those who are not yet able to establish the necessary operating procedures due to the time it takes to develop these procedures.

The FDA updated guidelines state, “Considering these issues and recognizing the immediate need for convalescent plasma to treat hospitalized patients with COVID-19, we intend to exercise temporary enforcement discretion regarding the [investigational new drug application] IND requirements for the use of investigational convalescent plasma.” The FDA sets forth circumstances that must be met for eligibility for temporary enforcement discretion, including:

  • The convalescent plasma is intended to treat hospitalized COVID-19 patients.
  • Informed consent must be obtained before administering investigational convalescent plasma. The FDA specifies, “Informed consent should include, at a minimum, a statement that the use of convalescent plasma is investigational and a discussion of its potential risks and benefits.”
  • The investigational convalescent plasma must be collected by registered blood establishments from donors who meet all eligibility requirements and qualifications of the FDA guidance.
  • The container label of investigational convalescent plasma must include specific language detailed in the guidance.

Enforcement discretion will be exercised for 90 days following the issuance of the updated guidance, according to the FDA. Clinical laboratory leaders wanting to learn more should read the full text of the updated guidance here.

Related Resources:

Investigational COVID-19 Convalescent Plasma: Guidance for Industry

FDA: Recommendations for Investigational COVID-19 Convalescent Plasma