First Molecular Non-Prescription, At-Home Test for COVID-19
New EUA for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use; for use in adults or children age 2 or older.
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
New COVID-19 Antigen Test for Prescription Home Use
New EUA for the Quidel QuickVue At-Home COVID-19 Test; individuals can rapidly collect and test their sample at home.
Emergency Use Authorizations (EUAs) for COVID-19
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
Medical Device Updates
Robotically-Assisted Device for Transvaginal Hysterectomy
Mar 1 - New surgical device provides a minimally invasive gynecologic surgical option for non-cancerous conditions.
New Device Helps Protect Athletes’ Brains During Head Impacts
Feb 26 - The FDA authorized marketing of a non-invasive medical device that athletes can wear when playing sports.
First-of-Its-Kind Implant for Treating Rare Bone Disease
Feb 17 - The FDA approved a 3D-printed implant, made for each patient individually, to replace the talus bone in the ankle.
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.