Which of the following would come under the purview of the Medicinal Device Amendment to the FDCA?
A) a new oral medication for depression
B) a new range of cosmetics to reduce signs of aging
C) a new and compact heart pacemaker
D) a revolutionary drug therapy for cancer

Question

Quizplus · Accepted Answer

The Medicinal Device Amendment to the FDCA specifically regulates medical devices, which include any apparatus, machine, implant, or other similar item intended for use in the diagnosis, treatment, or prevention of disease or other medical conditions. A heart pacemaker falls under this category and would come under the purview of this amendment.

Option A (oral medication for depression) and Option D (drug therapy for cancer) would come under the regulatory purview of the Food, Drug, and Cosmetic Act (FDCA) without the need for the Medical Device Amendments.

Option B (cosmetics to reduce signs of aging) would not come under the purview of either the FDCA or the Medical Device Amendments, as cosmetics are regulated separately.

Which of the Following Would Come Under the Purview of the Medicinal