News & Analysis as of

IRB Investigational Device Exemptions

Bass, Berry & Sims PLC

Research Using De-Identified Specimens: A Reminder from FDA

Bass, Berry & Sims PLC on

On October 18, the Food and Drug Administration (FDA) issued a letter reminding developers of in vitro diagnostics (IVDs) that institutional review board (IRB) approval is required before initiating a clinical investigation...more

Hogan Lovells

FDA details recommendations for live case presentations during medical device clinical trials in final guidance

Hogan Lovells on

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

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