SOCRA CCRP Practice Exam

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Which studies require submission of an IDE application?

All clinical device studies
Device studies not intended for human use
Studies supporting premarket approval and some 510(k) notifications
In-vitro diagnostics studies only

The correct answer is: Studies supporting premarket approval and some 510(k) notifications

Studies requiring submission of an IDE application include those that support premarket approval and some 510(k) notifications. Option A is incorrect because not all clinical device studies require an IDE application. Option B is incorrect because even if a device is not intended for human use, if it supports premarket approval or a 510(k) notification, an IDE application is still required. And option D is incorrect because in-vitro diagnostics studies do not require an IDE application unless they also support premarket approval or a 510(k) notification.