During the COVID-19 public health emergency, the FDA has used its emergency use authorization to allow the use of unapproved medical devices or unapproved uses of authorized medical devices to combat the virus.
Here are 11 medical devices the FDA has granted emergency use authorization for since March 28:
1. Imported, non-National Institutes of Occupational Safety and Health-approved disposable filtering facepiece respirators to prevent user exposure to airborne pathogenic particles.
2. NIOSH-approved air purifying respirators for use in healthcare settings to prevent user exposure to airborne pathogenic particles.
3. Battelle Critical Care Decontamination System for sterilizing compatible N95 or N95-equivalent respirators.
4. Non-NIOSH-approved disposable filtering facepiece respirators made in China; the FFR prevents user exposure to airborne pathogenic particles.
5. Face shields for healthcare workers to use as personal protective equipment to cover the front and sides of the face to protect from COVID-19 exposure.
6. Steris V-Pro 1 plus, maX and maX2 Low Temperature Sterilization systems for use in decontaminating N95 or N95-equivalent respirators for individual reuse by healthcare workers.
7. Advanced Sterilization Products' Sterrad 100S, NX and 100NX sterilization systems for decontaminating N95 or N95-equivalent respirators for individual reuse by healthcare workers.
8. Stryker's Sterizone VP4 Sterilizer for N95 respirator decontamination cycle for sterilizing N95 or N95 equivalent respirators for individual reuse by healthcare workers.
9. Sterilucent HC 80TT Hydrogen Peroxide Sterilizer for decontaminating N95 or N95 equivalent respirators for individual reuse by healthcare workers.
10. Protective barrier enclosures for healthcare workers to use when caring for patients who are confirmed or suspected to have COVID-19 to prevent exposure.
11. Durham, N.C.-based Duke University Health System's decontamination system for sterilizing N95 or N95 equivalent respirators for reuse by healthcare workers.