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.
Save the Date: 2021 PEAC Meeting on Medical Device Recalls
On Oct 6, the Patient Engagement Advisory Committee meets to discuss device recalls. The meeting is open to the public.
Contact Us
Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993
(800) 638-2041
(301) 796-7100
Hours Available
Office of Communication and Education
@FDADeviceInfo
Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.