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Investigational COVID-19 Convalescent Plasma Guidance for Industry January 2022

Docket Number:
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

FDA plays a critical role in protecting the United States (U.S.) from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic.  FDA is committed to providing timely guidance to support response efforts to this pandemic.  

FDA is issuing this guidance to provide recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the public health emergency.  The guidance also provides recommendations to blood establishments on collection.  This document supersedes the guidance of the same title issued in February 2021 (previous versions January 2021, November 2020, September 2020, May 2020, and April 2020).  We have revised the guidance to reflect that the EUA authorizes COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting.   In addition, we have revised certain recommendations pertaining to COVID-19 convalescent plasma donors.  In sections III.B.1 and III.C.1, we now recommend that individuals qualify as COVID-19 convalescent plasma donors 10 days following complete resolution of symptoms.  We also have revised the recommendations in section III.B.1 that address when individuals who have received an investigational COVID-19 vaccine as a participant in a clinical trial or received an authorized or licensed COVID-19 vaccine, qualify as convalescent plasma donors.  Also, the section on FDA’s interim compliance and enforcement policy regarding the IND requirements for the use of investigational convalescent plasma has been removed because the period of enforcement discretion ended on May 31, 2021.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1825.


Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
[email protected]
(800) 835-4709
(240) 402-8010
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