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Life Sciences › Investigational Device Exemptions

Hogan Lovells

U.S. Congress embraces FDA’s approach to clinical trial diversity in new Omnibus legislation

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In the waning days of 2022, Congress passed the omnibus spending legislation to provide funding for the federal government through September 2023. The legislation contains numerous reforms focused on FDA bundled under Title...more

Bass, Berry & Sims PLC

Research Using De-Identified Specimens: A Reminder from FDA

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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 warns over use of robotically-assisted surgical devices

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Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in...more

Hogan Lovells

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

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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

Robinson+Cole Health Law Diagnosis

FDA Amends Regulations For Data From Foreign And Domestic Investigation For Medical Devices

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On February 21, 2018, the Food and Drug Administration (FDA) published a Final Rule, amending its regulations on acceptance of data from investigations for medical devices that are performed outside of the United States as...more

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