EUAs for Certain Respirators Revoked as N95 Access Increases
Jun 30 - FDA recommends using only FDA-cleared or NIOSH-approved respirators, including N95s, in health care settings.
Medical Devices
Topic Paragraphs
Coronavirus (COVID-19) and Medical Devices
Learn more about devices such as diagnostic tests, ventilators, and personal protective equipment (PPE)—including surgical masks, face shields, respirators, gowns, and gloves.
Learn MoreCOVID-19 Updates
South Korea’s Response to COVID-19: FDA Issues Report
The report describes the response strategy used by the South Korean government to “flatten the curve” of COVID-19.
Emergency Use Authorizations (EUAs) for COVID-19
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
Medical Device Updates
Imported BD Sodium Citrate Blood Specimen Collection Tubes
Jul 22 – FDA issued an emergency use authorization for imported BD “light blue top” blood specimen collection tubes.
Potential Concerns with NuVasive MAGEC System Implants
Jul 15 – Potential mechanical failures, concerns about tissue incompatibility (biocompatibility) associated with MAGEC.
Diagnostic Aid for Autism Spectrum Disorder (ASD) Authorized
Jun 2 – FDA authorizes machine learning-based software to help diagnose ASD in children 18 months-5 years of age.
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Center for Devices and Radiological Health
Food and Drug Administration
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Silver Spring, MD 20993
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Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.