A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?
FDA Law Blog
NOVEMBER 1, 2023
However, FDA states that this exemption does not apply to corporate or hospital laboratories that employ licensed practitioners, and the agency says FD&C Act otherwise contains no exception or limitation for devices manufactured by laboratories. FDA’s position is, however, only one side of the story. This comparison is misplaced.
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