RAC Medical Devices Exam Questions and Answers With Complete Solutions

RAC Medical Devices Exam Questions and Answers With Complete Solutions

A Special 510(k) relies on the following information:

a) Design control documentation

b) Guidance documents

c) Consensus standards

d) All of the above

[Ans: - d) All of the above

A Special 510(k) verifies and validates that a device meets Design Controls by all of the following EXCEPT:

A. Ensuring that design outputs meet design inputs

B. Ensuring that devices conform to defined user needs and intended uses

C. Conforming to the QS Regulation, CFR Part 820

D. Claiming substantial equivalence to a competitor device

[Ans: - D. Claiming substantial equivalence to a competitor device

(For a Special 510(k), you must claim equivalence to the applicant's own marketed device).

A design or labeling change to an existing device (including certain changes to the indications for use) may be appropriate for a Special 510(k) when:

A. The proposed change is submitted by the manufacturer legally authorized to market the existing device,

B. Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change, and

C. All performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format

D. All of the above

[Ans: - D. All of the above

FDA believes that well-established methods for a Special 510(k) may include which of the following:

A. Lesser-known test methods that can be proven effective by the manufacturer

B. Methods found in an FDA-recognized voluntary consensus standard or FDA guidance document

C. Full test reports including methods

D. Methods found acceptable by FDA through a competitor's 510(k)-clearance or premarket application (PMA) approval

[Ans: - B. Methods found in an FDA-recognized voluntary consensus standard or FDA guidance document

Device manufacturers may choose to submit an Abbreviated 510(k) when the submission relies on any of the following EXCEPT:

A. FDA guidance document(s)

B. Design Control validation and verification

C. Demonstration of compliance with special controls for the device type, either in a device-specific classification regulation or a special controls guidance document

D. Voluntary consensus standard(s)

[Ans: - B. Design Control validation and verification

If you are submitting a 510(k) to FDA that includes a summary of compliance with special controls, you are submitting a:

A. Special 510(k)

B. Traditional 510(k)

C. Abbreviated 510(k)

D. de novo 510(k)

[Ans: - C. Abbreviated 510(k)

(an Abbreviated 510(k) includes a summary report illustrating compliance to special controls or alignment with guidance documents or voluntary consensus standards)