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Question

Before a significant risk medical mobile app (MMA) study can commence, what does the sponsor need to do

1 Answer

  • Based on operational standards, before a significant risk medical mobile app (MMA) study can commence, the sponsor "must have an approved IDE from FDA."

    What are IDE and FDA?

    IDE is the acronym of Investigational Device Exemption. Approval of IDE validates the investigational device to be utilized in medical research to obtain safety and efficacy data.

    Similarly, FDA is the acronym of Food and Drug Administration. The responsibility of the FDA is to ensure there is safety and security of human and veterinary commodities, including drugs, biological products, and medical devices, among others.

    Hence, in this case, it is concluded that the correct answer is that the sponsor "must have an approved IDE from FDA."

    Learn more about the FDA here: https://brainly.com/question/14164603

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