The Ombu Library, in the Medical Device Regulations aisle, has an article on the use of “FDA Approved”. In conjunction with a 510(k) device, it renders the device misbranded. There is a similar prohibition against the phrase “FDA Registered”.
The Ombu Library, in the Medical Device Regulations aisle, has an article on the use of “FDA Approved”. In conjunction with a 510(k) device, it renders the device misbranded. There is a similar prohibition against the phrase “FDA Registered”.
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