The FDA July 14 will hold a public meeting of the "Ophthalmic Devices Panel of the Medical Devices Advisory Committee."
FDA
Simplifying Global Compliance
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FDA Issues Warning Over Unapproved Breast Implant Device
The FDA said that the surgeon has been advertising the unapproved device on his web site.
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Regulators on both sides of the Atlantic are optimistic they’ll meet the deadline, which they hope will allow them to direct more inspection resources elsewhere.
