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Medical Device Knowledgebase

FDA Clinical Related Questions

• I have a device that has not been cleared for marketing in the US – but I have to do a clinical evaluation

• What is an Institutional Review Board (IRB)?

• What does the FDA mean by an Investigational Device?

• What is an Investigational device exemptions (IDE)?

• Who does the FDA allow to act as a monitor for clinical trials?

• What is a Significant Risk Device (SR) as defined by the FDA?

• Who is a Sponsor (as defined by the FDA) for an IDE?