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In this section: Medical Devices

Medical Devices

Topic Paragraphs

Test plan for the digital health software precertification program

Test Plan for the Digital Health Software Precertification Program

Companies who plan in the next year to submit a premarket application for software as a medical device (SaMD) may participate.

Photo of person using glucose meter and smartphone

Devices for Diabetes Management: FDA Safety Communication

The FDA warns against the use of devices for diabetes management not authorized for sale in the U.S.

Diagram showing machine learning, artificial intelligence, pattern recognition, neural networks, automation, algorithm, data mining, and problem solving

Artificial Intelligence and Machine Learning in Software

Read the new discussion paper on Artificial Intelligence and Machine Learning-Based Software as a Medical Device.

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

Watch Webinars

Final Guidances

Draft Guidances

Search for Guidances

About the Center for Devices and Radiological Health

CDRH Management Directory by Organization

CDRHNew Daily Updates

Sign Up for Emails

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.