On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's current views on software regulation following the changes implemented in the 21st...more
On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program.
...more
This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational...more
7/26/2019
/ Clinical Trials ,
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Investigational Device Exemptions ,
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New Guidance ,
Pharmaceutical Industry ,
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Regulatory Requirements ,
Reviewability Determinations