Question

A manufacturer which of the following must file an IDE before conducting a human clinical study?

A. A device in commercial distribution before 28 May 1976 when used or investigated in
accordance with its indications in labeling in effect at that time
B. A device intended solely for veterinary use
C. A custom device being studied for safety and effectiveness in support of commercial
marketing
D. A device in commercial distribution before 28 May 1976 when used or investigated in
accordance with its indications in labeling in effect at that time and intended solely for
veterinary use

Answer 1

Manufacturers must file an IDE for custom devices being studied for safety and effectiveness in support of commercial marketing before conducting human clinical studies.

Step-by-step explanation:

A manufacturer must file an Investigational Device Exemption (IDE) before conducting a human clinical study if the device is a custom device being studied for safety and effectiveness in support of commercial marketing. Devices in commercial distribution prior to May 28, 1976, used or investigated in accordance with their original labeling, and devices intended solely for veterinary use do not require an IDE for human clinical studies.

The Center for Devices and Radiological Health (CDRH) is a branch of the FDA which oversees the premarket approval of medical devices. Therefore, option "C", concerning a custom device being studied for commercial marketing, requires an IDE because it involves human clinical trials and must be regulated to ensure the device's safety and effectiveness.If a manufacturer intends to conduct a human clinical study, they must file an Investigational Device Exemption (IDE) with the FDA. The IDE is required for devices that are either in commercial distribution before 28 May 1976 or intended solely for veterinary use. For custom devices being studied for safety and effectiveness in support of commercial marketing, an IDE is also necessary. Therefore, the correct option is C.