Pharmacy Technician PTCB Practice Test

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Medical device safety alerts are issued by the FDA when a device:

  1. may present an unreasonable risk of substantial harm

  2. is used by a person for whom it was not prescribed

  3. is superseded by a newer device for the same purpose

  4. has not been patented prior to manufacturing

The correct answer is: may present an unreasonable risk of substantial harm

Medical device safety alerts are issued by the FDA when a device may present an unreasonable risk of substantial harm. This means that there is a potential for the device to cause harm or injury to the patient. The other options are incorrect because B: Using a device for someone who it was not prescribed for may lead to risks or complications, but it does not directly address the safety of the device itself. C: A newer device being available does not necessarily indicate that the older device is unsafe. D: A patent does not guarantee the safety of a medical device. The FDA evaluates the safety and effectiveness of a device through their own standards and regulations.

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