SOCRA CCRP Practice Exam

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What makes a device study exempt from IDE regulations?

In distribution before May 1976
Exclusive use in veterinary medicine
Used in significant risk research
Both A and B

The correct answer is: Both A and B

An investigational device exemption (IDE) allows for the investigational device to be used in a clinical study to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to FDA. Both options A and B would exempt a device from IDE regulations. Option A refers to devices that were already in distribution before May 1976, which was the date of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Option B refers to devices exclusively used in veterinary medicine, which are regulated separately from human-use medical devices. Option C, used in significant risk research, does not exempt a device from IDE regulations as it involves potentially high-risk studies. Therefore, options A, B, and C are incorrect in terms of exempting a device from IDE regulations.