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RAC Practice Exam Questions and Answers A+ Graded
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RAC Practice Exam Questions andAnswers A+ Graded
All of the following are goals of PIC/S EXCEPT:
o A) Mutual recognition of inspections
o B) Publication of aide-memories for medical device inspections
o C) Harmonization of GMP requirements
o D) Training of inspectors - -Answer: Publication of aide-memories for
medical devices inspections
The PIC scheme does not cover medical devices. Regulatory Reference: PIC/S
1/95 (Rev. 4)
-According to GHTF, key definitions and concepts for clinical evidence
including the following, EXCEPT:
o A) Clinical investigation is any systematic investigation or study in or on
one or more human subjects, undertaken to assess the safety and/or
performance of a medical device
o B) A clinical investigation does not include feasibility studies and is limited
to studies conducted for the purpose of gaining market approval or
investigations conducted following marketing approval.
o C) Clinical data are defined as "safety and/or performance information that
are generated from the clinical use of a medical device."
o D) Clinical evaluation is defined as "the assessment and analysis of clinical
data pertaining to a medical device to verify the clinical safety and
performance of the device when used as intended by the manufacturer." - -
Answer: A clinical investigation does not include feasibility studies and is
limited to studies conducted for the purpose of gaining market approval or
investigations conducted following marketing approval.
Routine post market surveillance does not support innovative technology
without precedents (or predictive device) in the clinical investigation period
(no comparable device exists). A clinical investigation can include feasibility
studies and those conducted for the purpose of gaining market approval or
investigations conducted following marketing approval. Regulatory
reference: Clinical Evidence- Key definitions and concepts GHTF/SG5/N1R8:
in the definitions chapter.
-GHTF guidelines for Adverse Event Reporting for medical devices
recommend that a trend report:
o A) Be submitted when there has been no change in the number or rate of
reportable events.
o B) Be submitted when there is a significant increase in the rate of already
reportable events.
o C) Be submitted based on the requirements of the GHTF
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