US Medical Device Regulations Quiz!

30 Questions | Total Attempts: 489

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Medical Quizzes & Trivia

Questions and Answers
  • 1. 
    A company wants to modify its device such that there is a major change to the fundamental scientific technology of the device. The FDA has published a guidance on this technology and special controls have been established. This change would be best filed as a(n):
    • A. 

      Special 510(k)

    • B. 

      Abbreviated 510(k)

    • C. 

      Traditional 510(k)

    • D. 

      PMA

  • 2. 
    A defective product was released into distribution and has caused patient injuries. The patients were treated in a local hospital and may suffer further reversible medical consequences as a result of the defective product. If this product is recalled from the market, which of the following recall classifications would most likely be assigned?
    • A. 

      Class I

    • B. 

      Class II

    • C. 

      Class III

    • D. 

      Class IV

  • 3. 
    A legally marketed device to which equivalence is drawn in a premarketing submission is known as the:
    • A. 

      Market comparator device

    • B. 

      Placebo device

    • C. 

      Predicate device

    • D. 

      Substantially equivalent device

  • 4. 
    A company's competitor is marketing a Class II suture which dissolves during the third week of use. The company's current product has to be removed by a physician. However, a change in weaving configuration gives this product the same dissolving time as the competitor's. When can the company's new suture be marketed?
    • A. 

      This requires a new 510(k) since significant change in product instructions might effect efficacy

    • B. 

      After submission in a periodic report

    • C. 

      After reporting clinical studies in an annual report

    • D. 

      After submission of labeling change

  • 5. 
    What does the 510(k) number, such as K130001, mean, and what does it encode?
  • 6. 
    What offices in the CDRH review 510(k) applications?
  • 7. 
    During the substantive review, what day should you expect to hear back from the FDA?
  • 8. 
    If your 510(k) is in interactive review (the clock has not stopped), to whom can you send your communications?
  • 9. 
    How often does the FDA update the 510(k) database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm)?
  • 10. 
    If the FDA meets all of its performance goals, what is the (theoretical) longest time a submission could take to get through the process?
  • 11. 
    Which of the following phrases describes a device that is not regulated as a medical device by FDA?  A device that:
    • A. 

      Affects the structure of the human body.

    • B. 

      Cures or prevents disease in humans or animals.

    • C. 

      Achieves its effect through chemical action on the human body.

    • D. 

      Is recognized by the United States Pharmacopoeia.

  • 12. 
    Which of the following is included in the “General Controls” provisions by FDA?
    • A. 

      FDA guidance documents

    • B. 

      Patient registries

    • C. 

      Misbranding

    • D. 

      Performance standards

  • 13. 
    All of the following regulations were  authorized by the Medical Device Amendments of 1976 except:
    • A. 

      Good manufacturing practices

    • B. 

      Substantial equivalence

    • C. 

      Clinical study requirements

    • D. 

      Design controls

  • 14. 
    Which of the following descriptors is most helpful in narrowing a search for a known device using FDA’s classification database?
    • A. 

      Regulation number

    • B. 

      Product code

    • C. 

      Classification

    • D. 

      Submission type (regulatory pathway)

  • 15. 
    Which of the following statements is true about FDA premarket submissions?
    • A. 

      FDA usually inspects a manufacturer’s facility prior to granting 510(k) clearance.

    • B. 

      FDA requires clinical data with all 510(k) submissions.

    • C. 

      All class II devices require 510(k) clearance.

    • D. 

      The de novo pathway provides a route to 510(k) clearance for low and moderate risk new devices.

  • 16. 
    During which phase of the medical device life cycle are clinical studies typically conducted to generate data to support premarket submissions?
    • A. 

      Feasibility

    • B. 

      Product Development

    • C. 

      Product Validation

    • D. 

      Product Verification

  • 17. 
    Which of the following is not true about the Quality System Regulation?
    • A. 

      Design reviews and/or phase reviews are required prior to market launch.

    • B. 

      Manufactures must monitor the performance of their devices following market launch and make corrections as needed.

    • C. 

      Changes to design input after market launch require FDA approval.

    • D. 

      Clinical studies should be conducted with prototypes manufactured using methods and procedures expected to be used for ongoing production.

  • 18. 
    Name four subsystems of the Quality System Regulation that FDA inspectors usually examine closely during inspection of a device manufacturer.
  • 19. 
    Which of the following options can reduce the time required to obtain FDA clearance or approval?
    • A. 

      Pay FDA a User fee.

    • B. 

      Submit a 510(k) application to a third party reviewer.

    • C. 

      Complete the facility registration and device listing prior to 510(k) submission.

    • D. 

      Include a cost-effectiveness analysis with the 510(k) submission.

  • 20. 
    Which of the following descriptions best describes a Class 2 device?  Devices that:
    • A. 

      Are used in sustaining or supporting human life.

    • B. 

      Pose a moderate risk of injury or illness.

    • C. 

      Are of substantial importance in preventing impairment of human health.

    • D. 

      Are expected to be reasonably safe and effective using general controls.

  • 21. 
    Which of the following is not required by FDA prior to conducting a nonsignificant risk clinical study?
    • A. 

      Study protocol

    • B. 

      Investigational Device Exemption approval

    • C. 

      Informed consent

    • D. 

      Institutional Review Board approval

  • 22. 
    Under the Quality System Regulation, management is responsible for all of the following activities except:
    • A. 

      Establishing a quality policy for the company

    • B. 

      Periodically reviewing quality control procedures

    • C. 

      Providing IRB approval

    • D. 

      Hiring and training necessary quality assurance staff

  • 23. 
    Which of the following activities is regulated by FDA during the Feasibility Phase?
    • A. 

      Conducting laboratory studies to understand new technologies

    • B. 

      Changing design input requirements

    • C. 

      Building non-clinical prototype devices

    • D. 

      Collecting human study data

  • 24. 
    Product development projects should follow Design Controls procedures in all of the following situations except:
    • A. 

      During testing in support of future human studies

    • B. 

      Upon deciding to develop a commercial product and approving product requirements (design input)

    • C. 

      During studies to demonstrate proof of concept

    • D. 

      While validating a manufacturing process

  • 25. 
    Which of the following does FDA consider to be one of the most important Design Controls related activities?
    • A. 

      Risk analysis

    • B. 

      Validation testing

    • C. 

      Design reviews

    • D. 

      Design input

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