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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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About the Author
Proxima CRO Team
Taylor Lunsford, MGA
Regulatory Associate II
Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.

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.

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