Omicron Variant: COVID Molecular Tests That May Be Impacted
Dec 28 – The performance of certain EUA-authorized molecular tests may be impacted by mutations in the omicron variant.
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
Policies to Help Ensure COVID-19 Test Accuracy, Reliability
Nov 15 – FDA updates test policies to help ensure accuracy & reliability of tests, increase access to at-home tests.
Emergency Use Authorizations (EUAs) for COVID-19
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
Medical Device Updates
First Laser-Based Device for IVC Filter Removal Authorized
Dec 21 – An IVC filter is a small cage-like device inserted into the interior vena cava (IVC) to capture blood clots.
Virtual Reality System for Chronic Pain Reduction Authorized
Nov 16 – FDA authorized marketing of EaseVRx to help with pain reduction in adults with chronic lower back pain.
Updated Safety Communication on Philips Resperonics Recall
Nov 12 – Update provides additional info on the recall of ventilators, BiPAP, CPAP machines, recommendations for users.
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.