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1. Which of the following products ARE FDA regulated medical devices?
a. Examination gloves
b. Software to run an MRI machine
c. Home pregnancy kit
d. All of the above
2. Which of the following is NOT true about the premarket review of medical devices?
a. Clinical studies must be conducted if the manufacturer files a premarket approval application to market a device
b. The premarket review process guarantees the safety and effectiveness of medical devices
c. The manufacturer must develop good testing and manufacturing practices prior to marketing a device
d. A premarket notification can be filed by a manufacturer who can demonstrate the similarity of the new device with those already on the market
3. Which of the following statements emphasizes the importance of post market surveillance by healthcare professionals?
a. Problems related to durability of a device will only be seen upon actual use in patients
b. The majority of medical devices do not undergo clinical trials
c. Premarket testing cannot detect problems with devices that may occur in certain clinical situations
d. All the above statements are true
4. Which of the following is NOT considered one of the three broad categories of medical device adverse events?
a. Use Problems
b. Clinical Problems
c. Labeling Problems
d. Device Problems
5. Which of the following is NOT a device user facility?
a. An oral surgeons office
b. A home healthcare agency
c. A diagnostic laboratory
d. A nursing home
6. Which of the following is NOT a reportable event under MDR?
a. Device user error resulting in the death of a hospital patient
b. A life-threatening device-related event which occurred in an a ambulance
c. Death of a patient due to a medical device which occurred in a physicians office
d. A serious injury to a patient which occurred in an outpatient mammography unit
7. Which of the following IS true for healthcare professionals working in a device user facility?
a. Health professionals are responsible for determining if a device-related event is reportable under MDR
b. Health professionals must report device-related events according to their facilities procedures
c. The responsibility for reporting device-related death or serious injury events rests ultimately with the health professional
d. Healthcare professionals should not play any role in helping their facilities identify device-related events
8. Which of the following incidents must be reported by the user facility under MDR?
a. The serious illness of a patient in a hospital which might have been caused by a drug
b. Confusing instructions about the operation of a medical device
c. Serious injury to a patient possibly caused by a medical device in a nurse practitioners office
d. A device malfunction in a same-day surgical facility which results in the death of a patient
9. Which of the following device reports would NOT be of interest to FDA?
a. Problems noted during the maintenance or servicing of a device which could affect the safe use of the device
b. Serious injury as a result of a rented hospital bed to a patient under the care of a home health agency
c. A health professionals individual preference for a particular device
d. User error caused by confusing device instructions
10. Which of the following statements is NOT true?
a. Reports from health professionals and other sources provide valuable information about device problems
b. To ensure the safety of medical devices, FDA can utilize mechanisms such as relabeling, Public Health Advisories, Safety Alerts, and recalls
c. Manufacturers are not required to investigate, evaluate, and identify the underlying causes of device adverse events reported to them.
d. If a product is not a medication (drug or biologic) and it is used for treatment or diagnosis, it is probably a medical device

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