Which of the following is true about class I medical devices:
A) the makers are registered with the FDA
B) the goods must be properly manufactured
C) the goods must be properly labeled
D) the goods are not subject to extensive controls
E) all of the other specific choices are correct

Question

Quizplus · Accepted Answer

All of the other specific choices are correct. Class I medical devices are low-risk devices and are subject to general controls, which include registration of the manufacturer with the FDA, proper manufacturing, proper labeling, and adherence to applicable FDA regulations. While they are not subject to extensive controls, they must still meet certain requirements to ensure their safety and effectiveness.

Which of the Following Is True About Class I Medical