Home » Breast Implant Makers May Need Larger Postapproval Studies, FDA says
Breast Implant Makers May Need Larger Postapproval Studies, FDA says
Manufacturers of breast implants may have to perform larger and longer post-approval studies in the future as a condition of FDA market approval. That assertion came from CDRH Director Jeffery Shuren during a press call Wednesday over concerns that silicone breast implants may lead to increased risk of some cancers and other health issues.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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