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

question 10

Multiple Choice

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

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