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An approved investigational device exemption (IDE) permits a device to be:
Suggested Answer: A
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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).
21 comments · newest first
AF
Afton
2 days ago
A is crucial for testing new devices.
MA
Marget
7 days ago
I agree, A is the right choice. Safety first!
SA
Sabrina
12 days ago
A makes sense. Can't sell or market yet.
IV
Ivory
18 days ago
Definitely A. It allows lawful shipping for studies.
LU
Luz
23 days ago
I think it's A. Clinical studies need IDE approval.
TH
Thaddeus
28 days ago
Definitely A. Compliance is key for studies.
ON
Onita
1 month ago
A is the best choice. It’s all about research.
GW
Gwenn
1 month ago
D is misleading. Humanitarian devices have different rules.
NI
Nickolas
1 month ago
C is risky. Patients should be enrolled.
LO
Lou
2 months ago
B is wrong. Selling isn't allowed yet.
ME
Merri
2 months ago
Agreed, A is correct. It allows testing safely.
EU
Eun
2 months ago
I think it's A. It makes sense for clinical studies.
PA
Paulina
2 months ago
Humanitarian device marketing? Seems sketchy to me.
BR
Brandon
2 months ago
B is definitely wrong, can't sell it yet!
GE
Gerald
2 months ago
Wait, can it really be used on patients not in a study? Sounds risky.
SI
Simona
3 months ago
Totally agree, that's the main point of an IDE!
JA
Jacquelyne
3 months ago
A) Shipped lawfully for the purpose of conducting a clinical study.
KA
Kati
3 months 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.
IS
Isaac
3 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.
TU
Tuyet
3 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.
AD
Adrianna
4 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.