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Cybersecurity Vulnerabilities in Certain GE Healthcare Central Stations and Telemetry Servers

Jan 23 - The FDA is raising awareness among health care providers and facility staff that these cybersecurity vulnerabilities may introduce risks to patients while being monitored.

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Featured Content

ISPOR FDA Summit 2020

Public Workshop - Using Patient Preference Information (PPI)

Feb 19 - Register for this one-day workshop: Using PPI in Medical Device Regulatory Decisions - Benefit-Risk and Beyond.
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Communications About Device Safety - Public Meeting - April 1

Jan 28 - Register by March 18, 2020 to attend the meeting or make oral presentations at the meeting.
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Table of Pharmaceogenetic Associations Evaluated by FDA

Feb 20 - New collaboration provides the FDA's view of the state of the current science in pharmacogenetics.

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Medical Device Safety

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

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

Search Medical Device Databases

more: Search Medical Device Databases

How Do I

Find Guidance Documents

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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.