Under the official definition of a "device", which of the following is NOT considered a device?

Prepare for the RAC Medical Devices Exam. Study with flashcards and multiple choice questions, each question has hints and explanations. Get ready for your exam!

The definition of a "device" within regulatory contexts, such as those established by the FDA, typically encompasses instruments, apparatus, machines, or contrivances intended for use in the diagnosis, treatment, or prevention of diseases or conditions, or for use in the restoration, correction, or modification of the anatomy or a physiological process.

Sterilizers used for device manufacturing operate as equipment necessary for preparing devices for safe use rather than being considered devices themselves. They serve a crucial role in the manufacturing process by ensuring that devices are free from contaminants, but they do not directly diagnose, treat, or affect any patient outside of this context. In contrast, the other options are all involved directly in patient care and treatment: X-ray film is utilized in diagnostic imaging, eyeglass lenses and frames assist in vision correction, and in vitro diagnostic kits are used to test biological samples for health conditions.

Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy