US Medical Device Regulations Quiz!
- 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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