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Regulatory Affairs Certification (RAC) Global

Scope
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Sample Questions
Question No 1:
510(k. Premarket Notifications for all of the following medical devices would be
reviewed by CDRH's Office of Device Evaluation except:
A.
B.
C.
D.

High Flux Hemodialyzer

Blood specimen collection device
Piston syringe
Cardiopulmonary bypass blood tubing

Answer: B
Question No 2:
The Quality System Regulation (QSR. for medical devices) (21CFR 820. pertains
to the manufacturing of which of the following)?
A.
B.
C.
D.

Finished devices, but not accessories

Finished devices and components of finished devices
Finished devices and accessories to finished devices
Finished devices, components, and accessories to finished devices

Answer: C
Question No 3:
The Quality System Regulation for Class III devices applies to the following
except?
A. Critical component manufacturers
B. Operations done by the manufacturer at facilities located in the United
States
C. Research on investigational devices tested outside of the United States
D. Contract Sterilizers

Answer: A

Question No 4:
The Quality System Regulation (QSR. for medical devices (21CFR 820. requires
all of the following except?
A.
B.
C.
D.

Management to make a commitment to quality

A Quality Plan that defines how quality will be met
Management must review the Quality System at least quarterly
A Quality representative must be identified and documented

Answer: C
Question No 5:
The Quality System Regulation (QSR. for medical devices regarding Design
Controls require which of the following)?
A. Documentation of early research of the design
B. Design and development plans address how design inputs and
requirements are managed
C. A product design can be outsourced by a manufacturer so they do not have
to maintain the documentation
D. Design activities are only required for Class III Investigational devices

Answer: B
Question No 6:
Design Control "verification" requires which of the following?
A.
B.
C.
D.

The product design meets the users needs

The process produces a product that meets predetermined specifications
The product design meets specified requirements
The product design meets the intended use requirements

Answer: C

Question No 7:
According to the QSR, Design Inputs are best described by the following?
A.
B.
C.
D.

The Operator's Manual and instructions on how to use the device

The Instructions for Use (IFU. of the device
Marketing claims and features that are required for the device
The performance requirements that the product must meet

Answer: D
Question No 8:
According to the QSR, Design Outputs contain the following?
A. The Device Master Record (DMR.
B. The documentation from the last phase of the complete Design Control
process
C. The test reports that support that the Design Inputs have been met
D. All of the packaging and labeling associated with the finished device
E. A and D above

Answer: E
Question No 9:
According to the QSR, Quality Audits must accomplish the following?
A.
B.
C.
D.
E.
F.

Meet the same requirements of the original GMP

Evaluate if the Quality System is in compliance with the QSR
Determine the effectiveness of the Quality System
Focus on Design Controls and the CAPA system
B and C above
A and D above

Answer: B, C, E

Question No 10:
According to the QSR, personnel involved in the design, manufacture,
distribution, servicing, and reporting must?
A. Must hold a Master's degree or higher
B. At a minimum receive procedure training once per year in their area of
responsibility
C. Be able to recite the Quality Policy, if asked
D. Be made aware of defects which may occur if they do not perform their job
correctly

Answer: D
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