Medical Devices

Emergency Use Authorizations (EUAs) for COVID-19 Diagnostic Tests, Ventilators, and Respirators

Mar 25 - EUAs make available diagnostic and therapeutic medical devices to diagnose and respond to the COVID-19 public health emergency.

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Medical Gloves: Conservation Strategies

Mar 20 – Recommended conservation strategies for surgeon’s gloves and patient examination gloves.

Woman wearing surgical mask and gown. Conservation Strategies.

Surgical Gowns and Masks: Conservation Strategies

Mar 11 - Recommended conservation strategies for health care providers and facilities.

N95 Respirators for Health Care Providers

Mar 3 - Authorization to allow health care personnel to use certain industrial respirators during the COVID-19 outbreak.

Device Advice

Information, education, and support for industry

Medical Device Safety

Safety Communications, Recalls, Letters to Health Care Providers, Reporting Adverse Events (MDR and MedSun)

Products and Medical Procedures

Approvals and clearances, information on medical devices by type

Digital Health

Cybersecurity, mobile medical applications, wireless medical devices, Software as Medical Device (SaMD)

Science and Research

CDRH research programs, epidemiology, medical device development tools (MDDT)

International Programs

International Medical Device Regulators Forum, Medical Device Single Audit Program (MDSAP)

News & Events

CDRHNew daily updates, webinars, meetings, workshops, conferences

Resources for You

Information for consumers and health care providers, letters to industry

510(k) Premarket Notification Database

Device Registration and Listing Database

Product Code Classification Database

MAUDE (Manufacturer and User Facility Device Experience) Database

Premarket Approvals (PMA) Database

All Medical Device Databases

Classify a Medical Device

Register and List a Device

Label a Device

Submit Adverse Event and Problem Reports (MDR)

Study and Market a Device

Find Device Approvals and Clearances

Find Device Recalls

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Final Guidances

Draft Guidances

Search for Guidances

About the Center for Devices and Radiological Health

CDRH Management Directory by Organization

CDRHNew Daily Updates

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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

DICE@fda.hhs.gov

(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.