Pulse Oximeter Accuracy and Limitations: Recommendations
The COVID-19 pandemic has caused an increase in the use of pulse oximeters, which have limitations.
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
COVID-19 Tests and Collection Kits Authorized by the FDA
The FDA has authorized over 300 tests and sample collection devices, including a wide variety of tests for use in a range of settings.
Emergency Use Authorizations (EUAs) for COVID-19
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
Medical Device Updates
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.
New Device to Reduce Snoring and Mild Sleep Apnea
Feb 5 - New prescription-only device is the first device used while awake that is intended to improve tongue muscle function.
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.