Monkeypox and Medical Devices
The FDA issued a policy for monkeypox tests to address the public health emergency.
Medical Devices
Topic Paragraphs
Medical Device Updates
FAQs on Philips Respironics Ventilator, BiPAP, and CPAP Recalls
Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall.
FDA Finalizes Rule to Facilitate Access to OTC Hearing Aids
This action enables consumers with perceived mild to moderate hearing impairment to purchase hearing aids from retailers without the need for a medical exam, prescription, or a fitting.
COVID-19 Updates
At-Home COVID-19 Antigen Tests- Take Steps to Reduce Your Risk of False Negative
The FDA recommends repeat testing following a negative result whether or not you have COVID-19 symptoms.
At-Home OTC COVID-19 Diagnostic Tests
List of authorized at-home OTC COVID-19 diagnostic tests and expiration date information.
Use and Store At-Home COVID-19 Tests Properly
FDA issued a safety communication to use and store at-home COVID-19 tests properly to avoid potential harm.
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.