Category: IDE

  • Does My Study Require An IDE?

    Does My Study Require An IDE?

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    by

    Lori
    in

    To launch a US medical device study, an approved Investigational Device Exemption (IDE)  may be required. 21CFR 812 is part of the Code of Federal Regulations (CFR) containing the procedures and requirements governing the conduct of clinical research of devices. If needed, FDA clearly describes the IDE application format. According to the regulations of 21 CFR 812,…