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U.S. Department of Health and Human Services

Medical Devices

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Blue Book Memos - ODE Guidance Memoranda

One of the responsibilities of the Office of Device Evaluation (ODE) is to develop and interpret regulations and guidelines regarding premarket notification submissions (510(k)s), premarket approval applications (PMAs), product development protocols (PDPs), device classifications, and investigational device exemptions (IDEs). The ODE guidance memoranda, affectionately referred to as "Blue Book Memos", clarify these guidelines and will be added to this list as they become available. We hope you find these Blue Book Memos helpful in your understanding of ODE policies and procedures.


510(k) Memoranda


General Program Memoranda