Medical Extended Reality Public Workshop - March 5
Jan 16 – Topic: Evaluation needs, gaps, and approaches for medical XR. Register by February 28.
Medical Devices
Topic Paragraphs
Quality Issues with Cardinal Health Surgical Gowns
Jan 16 - Cardinal Health has alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contain the gowns. Customers should immediately discontinue use of affected surgical gowns and procedural packs.
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Update: Essure Discontinuation, Ongoing Postmarket Activities
Jan 10 - Update on postmarket safety monitoring, all unused devices should have been returned by December 31, 2019.
New CDRH Learn Modules for Industry
Jan 13 - New educational modules on Quality Systems, Importing Devices, and Electronic Product Certification.
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.