COVID Emergency Guidance from the FDA: Sterilizer, Disinfectant, and Air Purifying Devices

During the declared public health emergency, FDA does not intend to object to the distribution and use of sterilizers, disinfectant devices, and air purifiers that are intended to be effective at killing the SARS-CoV-2 virus but do not already have FDA marketing authorization, without compliance with the following regulatory requirements where such devices do not create an undue risk in light of the public health emergency: prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81 or submission of a PMA Supplement under section 515 of the FD&C Act and 21 CFR 814.39, Registration and Listing requirements in 21 CFR 807, and Unique Device Identification requirements in 21 CFR 830 and 21 CFR 801.20. FDA believes such devices will not create such an undue risk where the performance and labeling elements in Sections IV.A and IV.B, respectively, are met. As an example, this would apply to a manufacturer of a new medical air purifier that has not been approved or cleared and that is effective in filtering out dust particles and bacteria, where the manufacturer would like to modify the filter mesh size in order to filter out viruses, including the SARS-CoV-2 virus.