Medical Devices
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News & Events (Medical Devices)
Press releases, meetings, conferences, and other announcements to keep the public apprised of significant news and activities related to medical devices.
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News Items
- Use expanded for FilmArray Respiratory Panel
FDA issues alert on potential dangers of unproven treatment for multiple sclerosis - Proposal aims to help reduce unnecessary radiation exposure for children
FDA announces plans to pilot end-stage kidney disease technology in new program FDA to discuss risks and benefits of metal-on-metal hip replacements New FDA guidance on considerations used in device approval, de novo decisions FDA approves LINX Reflux Management System to treat gastroesophageal reflux disease FDA proposes lower risk classification for certain tuberculosis tests - New silicone gel-filled breast implant approved
FDA reaches $1 million settlement with Pennsylvania medical device firm New Jersey company agrees to halt production of unapproved dental devices FDA and industry reach agreement in principle on medical device user fees
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Contact FDA
1-800-638-2041
301-796-7100
Fax:301-847-8149
CDRH-Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
WO66-4621
Silver Spring, MD 20993
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