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Tag: investigational device exemptions

> investigational device exemptions
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FDA proposes new rules to harmonize with Common Rule (Part II: protection of human subjects and IRBs) by Elisa A. Hurley, PRIM&R executive director

(PRIM&R) Public Responsibility in Medicine and Research

On September 28, the US Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRMs) to harmonize the…

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Navigating FDA-Regulated Research as an IRB

(PRIM&R) Public Responsibility in Medicine and Research

On May 3, 2022, PRIM&R hosted a webinar, Un-Common Rules: Navigating FDA-Regulated Research and the IRB. During the webinar, Belinda…

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Establishing a Clear Pathway for IRB Review of Artificial Intelligence/Machine Learning in AI Human Subject Research That Involves Software as a Medical Device

(PRIM&R) Public Responsibility in Medicine and Research

In the not-so-distant past, IRBs reviewing artificial intelligence and machine learning (AI/ML) protocols were quick to give not-human subject research…

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AER19 Blog Squad: The Confusion of Mobile Medical Devices

(PRIM&R) Public Responsibility in Medicine and Research

Back in 2004, before I started working for the Emory University IRB, I was working as a research coordinator in…

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PRIM&R advances the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building.