Serological (Antibody) Tests for COVID-19: Revised Policy
FDA outlines expectations for antibody test manufacturers, creates streamlined processes for independent validation.
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
Emergency Use Authorizations (EUAs) for COVID-19
EUAs make available diagnostic tests, respirators, ventilators, and related devices for COVID-19.
COVID-19 Diagnostic Test Accuracy and Availability
FDA has been proactive and supportive of test development to speed development and quickly authorize tests that science supports.
COVID-19 Info for Health Care Providers
Surgical Gowns and Masks: Conservation Strategies
Recommended conservation strategies for surgical masks, surgical and isolation gowns, and surgical suits (scrubs).
Medical Glove Conservation Strategies
Recommended conservation strategies for surgeon’s gloves and patient examination gloves.
Ventilator Supply Mitigation Strategies
Recommendations for the use of ventilators, ventilator accessories, and other respiratory devices.
Devices Track: August 27-28, 2020
Register today to attend the Devices Track during the Regulatory Education for Industry (REdI) Annual Conference.
Meeting Information and Registration
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.