The FDA is working to address the coronavirus disease (COVID-19) outbreak and keep you and your family informed on the latest developments. Here are answers to some frequently asked questions from consumers about convalescent plasma, personal protective equipment (PPE), and medical products:
Q: What is convalescent plasma and why is it being investigated to treat COVID-19?
A: Convalescent plasma is the liquid part of blood that is collected from patients who have recovered from the novel coronavirus disease, COVID-19, caused by the virus SARS-CoV-2. If you have fully recovered from COVID-19, you may be able to help patients currently fighting the infection by donating your plasma. Learn more about donating from this video.
COVID-19 patients develop antibodies in the blood against the virus. Antibodies are proteins that might help fight the infection. Convalescent plasma is being investigated for the treatment of COVID-19 because there is no approved treatment for this disease and there is some information that suggests it might help some patients recover from COVID-19. Further investigation is still necessary to determine if convalescent plasma might shorten the duration of illness, reduce morbidity, or prevent death associated with COVID-19.
Q. Can 3D printing be used to make PPE?
A. Personal protective equipment (PPE) includes protective clothing, gowns, gloves, face shields, goggles, face masks, and respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness. While it is possible to use 3D printing to make certain PPE, there are technical challenges. 3D-printed PPE may provide a physical barrier, but 3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators. The CDC has recommendations for how to optimize the supply of face masks. Find more information in the FDA FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic.
Q: Who should I contact if I have questions about medical devices or need more information?
A: Please contact the FDA’s Center for Devices and Radiological Health (CDRH)’s Division of Industry and Consumer Education (DICE) for general questions and information.
If you need additional information completing the diagnostic EUA template or wish to consider use of an alternative specimen type, please contact the Division of Microbiology Devices at (301) 348-1778 or email CDRH-EUA-Templates@fda.
If you have questions about the EUA for personal respiratory protective devices, including N95 respirators, please email CDRH-NonDiagnosticEUA-
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