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SOCRA CCRP Exam - Topic 2 Question 18 Discussion

Actual exam question for SOCRA's CCRP exam

Question #: 18
Topic #: 2

[All CCRP Questions]

An approved investigational device exemption (IDE) permits a device to be:

AShipped lawfully for the purpose of conducting a clinical study

BSold and marketed for profit

CUsed on a patient who is not enrolled on a clinical study

DMarketed as a humanitarian device

Show Suggested Answer

Suggested Answer: A

An Investigational Device Exemption (IDE) allows an unapproved medical device to be used in a clinical investigation.

21 CFR 812.1(a): ''An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act that would otherwise apply.''

It does not allow commercial sale (B), non-study clinical use (C), or marketing as a humanitarian device (D).

Thus, the correct answer is A (Shipped lawfully for clinical study).

21 CFR 812.1(a) (IDE exemption provisions).

by Gregoria at Jul 01, 2026, 04:10 PM

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