Breast Implant Labeling
Read the draft guidance, Certain Labeling Recommendations for Breast Implants - Considerations to Improve Patient Communication.
Medical Devices
Topic Paragraphs
The FDA warns that biotin may interfere with certain lab tests
Biotin, also called vitamin B7 and found in many dietary supplements, can significantly interfere with certain lab tests and cause incorrect results that may go undetected.
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Metal Implants and Dental Amalgam: Public Meeting and Papers
Read about our ongoing efforts to evaluate materials in medical devices to address potential safety questions.
CDRH Industry Basics Workshop - November 5, 2019
Join FDA experts for a live workshop and Q&A about 513(g) Request for Information and Custom Device Exemption on November 5, 2019.
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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
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
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Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.