Evaluation of Medical Devices in the US

An evaluation plan stating in particular the purpose, scientific, technical or medical grounds, scope of the evaluation and number of devices concerned 

The list of laboratories or other institutions taking part in the evaluation study 

The starting date and scheduled duration for the evaluations and, in the case of devices for self-testing, the location and number of lay persons involved 

A statement that the device in question conforms to the requirements of the Directive, apart from the aspects covered by the evaluation and apart from those specifically itemised in the statement, and that every precaution has been taken to protect the health and safety of the patient, user and other persons 

The conduct of studies of medical devices in the US that have not been cleared/ approved by the FDA is regulated via Investigational Device Exemption (IDE) regulations set out in 21 CFR Part 812. Considering the type of device and the level of associated risk involved, investigations maybe conducted as IDE-exempted studies. Abbreviated requirement studies, or studies subject to full IDE requirements. 

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