Must an IRB review a study conducted after submission of 510(k) to FDA but prior to FDA’s decision on the submission?

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Yes. During FDA’s review of the premarket notification submission, the device remains an investigational product. Therefore, the human subject protection (informed consent and additional safeguards for children in research), IRB, and IDE regulations apply. The device may not be distributed, except for investigational use, unless FDA clears the device for marketing.

About the Author
Proxima CRO Team
Taylor Lunsford
Regulatory Affairs Associate

Taylor Lunsford is a Regulatory Affairs Associate from Houston, Texas and holds degrees from the University of Houston and the Defense Language Institute. Before working with Proxima, he served in the Army as a Mandarin Chinese translator and intelligence analyst.

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