Of what clinical significance is the imposition of the FDA's safety and efficacy standard on the introduction of new devices into the physical therapy marketplace?
A)This standard ensures that the manufacturer has paid the necessary fees to the FDA to market and label the device.
B)This standard ensures that the device, when marketed, is safe for use on human subjects.
C)This standard ensures that when a device is labeled for a specific indication, it has been proven in clinical studies to treat that indication.
D)Both B and C

Question

Quizplus · Accepted Answer

The FDA's safety and efficacy standard is crucial because it ensures that devices are safe for human use (B) and that they have been clinically proven to treat the conditions they are marketed for (C). This helps protect patients from ineffective or dangerous treatments.

Of What Clinical Significance Is the Imposition of the FDA's