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Medical Device Updates

Man using a CPAP machine

Update: Recalled Philips Ventilators, BiPAP Machines, and CPAP Machines

As part of FDA's continued efforts to ensure consumers have the latest information on the Philips' recall, the FDA published a new online resource, including a comprehensive timeline of FDA activities related to the June 2021 recall.
Breakthrough Devices Feature Graphic

Updated Final Guidance for Breakthrough Devices Program

The updates align with the actions outlined in CDRH’s Strategic Priorities to Advance Health Equity by supporting innovation of new and existing technologies that address health inequities.
Ultraviolet (UV) wand

Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation

The FDA updated the list of UV wand products that may present a potential risk of injury. The FDA recommendations have not changed.
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CDRHNew

Comprehensive List of Latest CDRH Updates

Science and Research

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

International Affairs

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

Resources for You

Information for consumers and health care providers, letters to industry

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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

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