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.
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
Antibody Tests and Immunity After COVID-19 Vaccination
Antibody tests should NOT be used to determine protection against COVID-19, especially after COVID-19 vaccination.
Emergency Use Authorizations (EUAs) for COVID-19
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
Medical Device Updates
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.
Stop Using Certain Syringes, Needles Manufactured by HAIOU
May 20 - Failures reported for two syringe and needle configurations from Guangdong Haiou Medical Apparatus (HAIOU).
Attend the Devices Track at the REdI Conference: July 21-22
The conference is free, registration is required. Topics include regulatory science tools, 510(k), Q-Sub, and more.
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.