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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.

CDRH's Response to COVID-19 Infographic

Data visualization for January 1-December 28, 2020


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 respirators and 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

Device or Topic Information
3D printing of medical devices FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic
Adverse event reporting for medical devices Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents
Bioburden reduction systems Bioburden Reduction Systems Frequently Asked Questions
Digital health Digital Health Policies and Public Health Solutions for COVID-19
Glucose meters FAQs on Home-use Blood Glucose Meters Utilized Within Hospitals During the COVID-19 Pandemic
Hospital beds, stretchers, and mattresses Hospital Beds, Stretchers, and Mattresses During the COVID-19 Pandemic
Importing medical devices
Medical device manufacturing personnel Protecting the Health and Safety of Medical Device Manufacturing Personnel During COVID-19
Medical device shortages
Registration and listing Registration and Listing of Medical Devices during the COVID-19 Pandemic
Supply chain notifications
Temperature measuring devices Non-contact Temperature Assessment Devices During the COVID-19 Pandemic
Ultraviolet (UV) lamps UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection, and Coronavirus



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