Question

Which of the following is NOT true of the regulation of medical devices?

		In response to deaths attributed to the Dalkon Shield, in the 1970s the FDA's authority was expanded to include premarket review of medical devices.
		Initially, the jurisdiction of the FDA was limited to the sale of products believed to be unsafe or that made misleading claims of effectiveness.
		Under the Safe Medical Devices Act of 1990, health care providers are legally required to report injuries and deaths caused by medical devices.
		Under FDA regulations, Class III devices are those which pose the lowest risk and are generally simple in design.

Answer 1

Correct Answer - Under FDA regulations, Class III devices are those which pose the lowest risk and are generally simple in design

In contrast to what is being mentioned in the question, Class I devices are the simplest device and comes with the lowest risk to the patient followed by Class II device. Class III medical devices are the most complicated medical devices and pose high risk to the client. They are generally used for sustaining or supporting life and only comprises of 10% of medical that FDA regulates.