US Medical Device Regulations Quiz

20 Questions | By CERSI | Last updated: Oct 26, 2022 | Total Attempts: 957

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US Medical Device Regulations Quiz - Quiz

Do you live in the US and are related to the medical field? If yes, this US medical device regulations quiz will be very helpful to you. The Medical Device Regulation (MDR) works on the legal framework for medical devices and introduces new principal and supportive responsibilities in the assessment of certain categories of products. These questions will expand your knowledge in terms of medical device regulations and how they work. Let's go!

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 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.

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.
5.

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
6.

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
7.

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)
8.

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.
9.

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
10.

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.
  
  Manufacturers must monitor the performance of their devices following the 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.
11.

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.
12.

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
13.

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
14.

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
15.

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
16.

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
17.

The Design History File is used for all of the following purposes, except:
- A.
  
  Providing evidence that the Design Controls procedures were followed
- B.
  
  Recording results of clinical trials
- C.
  
  Archiving results of customer complaints
- D.
  
  Documenting verification of sterilization testing
18.

Which of the following statements is false about clinical studies involving investigational devices?
- A.
  
  Study results can be used to establish device safety.
- B.
  
  Institutional Review Board approval is required before starting a study.
- C.
  
  Studies can be used to evaluate device concepts and refine a study protocol.
- D.
  
  Study data can be used to manage patient care.
19.

Which of the following activities may not be required for design changes to an FDA-cleared or approved device?
- A.
  
  Document the change in the Device Master Record
- B.
  
  Obtain FDA approval before implementing the change
- C.
  
  Verify or validate the change before implementing
- D.
  
  Review and approve the change according to an established design change procedure
20.

Which of the following is false regarding Corrective and Preventive Action procedures:
- A.
  
  Corrective and Preventive Action procedures are used during clinical studies to collect adverse effects information.
- B.
  
  Corrective and Preventive Action deficiencies are one of the most frequently cited problems in FDA warning letters to manufacturers.
- C.
  
  Corrective and Preventive Action procedures involve investigating potential product quality problems.
- D.
  
  Changes identified as part of the Corrective and Preventive Action procedures should be verified or validated before implementation.