AnInvestigational Device Exemption (IDE)allows an unapproved medical device to be used in aclinical 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 isA (Shipped lawfully for clinical study).
References:
21 CFR 812.1(a) (IDE exemption provisions).