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  1. Emergency Situations (Medical Devices)

Coronavirus (COVID-19) and Medical Devices

Emergency Use Authorizations (EUAs) for Medical Devices During COVID-19

EUAs for in vitro diagnostic tests, personal protective equipment (PPE), and more.

Contacts for Medical Devices During COVID-19

Industry hotline and email addresses for EUAs, device availability, enforcement policies, and more.

 


In Vitro Diagnostic Tests: COVID-19 Tests, Including Antibody Tests

Laboratory technician wearing personal protective equipment prepares COVID-19 samples for testing

For general information:

For test developers (laboratories and manufacturers):

For health care providers and clinical laboratory staff:

Information on antibody (serology) tests:

Guidances:


Masks and Respirators

Health care staff wearing PPE: masks, gloves, gowns, head coverings.

For general information:

Flowcharts:

Information on respirator EUAs

Information on respirators for health care professionals:

Other information for health care professionals:

Guidance:


Gloves, Gowns, and Other Personal Protective Equipment (PPE)

Gloves

For general information:

For health care professionals:

Guidance:


Ventilators and Ventilator Accessories

Patient in hospital bed on a ventilator

For general information:

For health care professionals:

Guidance:


Other Medical Devices and Topics



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