The U.S. FDA posted a guidance for emergency use authorizations for decontamination and bioburden reduction of surgical masks and respirators, which supersedes some of the content of the April enforcement policy for masks and respirators. The policy, driven by the COVID-19 pandemic, will require that the sponsor list the surgical masks and/or respirators deemed compatible with the decontamination or bioburden reduction system, and the number of cycles a mask or respirator can withstand in that unit. The guidance also recommends the sponsor provide a hierarchy of pathogen susceptibility to the decontamination or sterilization method, and recommends the sponsor provide information such as validation data and information on material compatibility. The agency also posted a revised edition of the enforcement policy.
The FDA posted a list of respirator masks that no longer enjoy emergency use authorization (EUA) for the COVID-19 pandemic, a list of roughly six dozen masks that the agency said no longer meet the eligibility criteria. The removed masks can win a renewed EUA status if the sponsors meet NIOSH filtration standards within 45 days of the May 7 de-listing date, although masks removed after May 7 will not be eligible for reentry under the third criterion for N95 masks as seen in the agency’s May 7 letter to manufacturers and users. The agency also posted an advisory regarding the use of Sterrad sterilization systems for N95 and N95-equivalent respirators, stating that these sterilizers must be used in conformance with recommended decontamination cycles.
India’s National Pharmaceutical Pricing Authority said it has received reports of hoarding and “differential higher pricing” of N95 masks, which are both offenses under the Essential Commodities Act of 1955. NPPA said N95 masks had already been deemed an essential commodity, and that prices had already been fixed in March along with prices for articles such as surgical gloves and hand sanitizers. Manufacturers and distributors of these articles are directed to ensure availability of the affected products at the listed prices.
Australia’s Therapeutic Goods Administration added two antibody tests to the list of tests authorized for distribution in Australia for the COVID-19 pandemic, including the rapid immunoglobulin G/ immunoglobulin M (IgG/IgM) test by Nantong Egens Biotechnology Co. Ltd., of Nantong, China. TGA said the rapid IgG/IgM test by Ntbio Diagnostics Inc., of Surrey, Canada, is also available for distribution.