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Vetted Domestic PPE Manufacturers
Supply chain teams across the U.S. continue to face supply shortages.
FDA approves COVID-19 antigen test, first chikungunya vaccine
The Food and Drug Administration Nov. 9 cleared for marketing the Flowflex COVID-19 Antigen Home Test, the first COVID-19 antigen test and second COVID-19 at-home test to successfully complete traditional premarket review.
HHS awards $600M to make COVID-19 tests; public can order 4 more free
The Department of Health and Human Services’ Administration for Strategic Preparedness and Response yesterday awarded $600 million for 12 domestic COVID-19 test manufacturers to expand capacity.
NIOSH revokes respirators temporarily approved for COVID-19 PHE
The National Institute for Occupational Safety and Health this week revoked eight N95 filtering facepiece respirator approvals and four powered air-purifying respirator approvals issued for the COVID-19 public health emergency that ended May 11, meaning health care providers may no longer use them.
FDA updates use recommendations for Halyard surgical N95 respirator
In response to questions from AHA and others and informed by testing results, the Food and Drug Administration April 21 announced that health care providers without alternative options may continue to use a certain version of the O&M Halyard FLUIDSHIELD Surgical N95 Respirator Mask for fluid barrier protection if they wear a face shield over the respirator.
FDA: Don’t use certain N95 respirators and masks made by O&M Halyard
Health care providers and consumers should not use certain N95 respirators made by O&M Halyard because they do not meet quality and performance expectations, and should not use certain surgical masks and pediatric face masks made by the company for fluid barrier protection, the Food and Drug Administration announced today.
HHS: FDA COVID-19 emergency use authorizations remain in effect
Health and Human Services Secretary Xavier Becerra this week amended the February 2020 COVID-19 emergency use authorization declaration so that the Food and Drug Administration’s emergency use authorizations for COVID-19 diagnostics, personal protective equipment, other medical devices, and drug and biological products will remain in effect until there is no longer a “significant potential” for a COVID-19 public health emergency or the authorized devices or products have been approved.
NIOSH rescinds approval for Pacific PPE respirators
The National Institute for Occupational Safety and Health recently rescinded all respirator approvals issued to Pacific PPE Corp. at the company’s request.
Report calls for federal, other action to prevent medical supply shortages
A new congressionally mandated report from the National Academies of Sciences, Engineering, and Medicine recommends actions to help prevent medical product shortages and ensure access to essential drugs and devices.
Company alerts providers to potential for certain ventilators to stop working
Vyaire Medical recently a