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SOCRA CCRP Exam - Topic 2 Question 18 Discussion

An approved investigational device exemption (IDE) permits a device to be:
A) Shipped lawfully for the purpose of conducting a clinical study
B) Sold and marketed for profit
C) Used on a patient who is not enrolled on a clinical study
D) Marketed as a humanitarian device

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:

Show Suggested Answer Hide 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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Lou
3 days ago
B is wrong. Selling isn't allowed yet.
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Merri
8 days ago
Agreed, A is correct. It allows testing safely.
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Eun
14 days ago
I think it's A. It makes sense for clinical studies.
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Paulina
19 days ago
Humanitarian device marketing? Seems sketchy to me.
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Brandon
24 days ago
B is definitely wrong, can't sell it yet!
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Gerald
29 days ago
Wait, can it really be used on patients not in a study? Sounds risky.
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Simona
1 month ago
Totally agree, that's the main point of an IDE!
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Jacquelyne
1 month ago
A) Shipped lawfully for the purpose of conducting a clinical study.
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Kati
1 month ago
I’m hesitant about A, but I think it’s the only option that makes sense. The others seem off, especially selling or marketing the device.
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Isaac
2 months ago
I feel like I've seen a question like this before, and it was definitely about shipping devices for studies. A is probably correct, but I could be wrong.
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Tuyet
2 months ago
I remember something about IDEs being related to clinical trials, so A seems right. I just hope I don't confuse it with other regulations.
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Adrianna
2 months ago
I think an IDE allows a device to be shipped for clinical studies, so I would go with A. But I'm not entirely sure.
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