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RAPS Practice Test – Questions & Answers
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RAPS Practice Test – Questions & Answers
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RAPS Practice Test – Questions & AnswersA company is performing routine site monitoring of its pivotal clinical study
for a blood sugar meter and finds one site has not consented 1/3 of its
subjects properly. What is the FIRST thing the company needs to do?
A. Stop the entire study
B. Inform FDA and ask for guidance
C. Re-train the study staff, including the principle investigator at that site on
GCP
D. Re-consent all improperly consented subjects ✔ Ans - D. Re-consent all
improperly consented subjects
The quality assurance manager of a small company with 12 employees is the
company's only internal auditor and has been performing all internal quality
system audits for three years. This does not meet the requirements for
performing internal quality systems audits because:
A. Auditor independence has not been ensured
B. There is no one in the company qualified to train the quality assurance
manager in quality auditing principles
C. Quality system audits cannot be performed by the same auditor for more
than two audits in a row
D. The Audit Reports need to be approved by a second internal auditor not
involved with the specific audit ✔ Ans - A. Auditor independence has not
been ensured
A medical device company is developing a product with drug, biologic and
device components. The product and indication have not been classified
previously by FDA. What is the most appropriate regulatory pathway?
A. An IDE and PMA should be submitted to CDRH, as the company is a medical
device company and is most familiar with medical device application
regulations
B. A Request for Designation (RFD) should be sent to Office of Combination
Products (OCP) at FDA to determine primary mode of action (PMOA) and
assign center with primary jurisdiction
C. An IND and NDA should be submitted to CBER because this is the strictest
regulatory pathway
D. The company should submit a marketing application to the appropriate
FDA center based on the company's determination of primary mode of action
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(PMOA) ✔ Ans - B. A Request for Designation (RFD) should be sent to
Office of Combination Products (OCP) at FDA to determine primary mode of
action (PMOA) and assign center with primary jurisdiction
When multiple facilities are involved in a Class III device's design, assembly or
processing, the PMA holder should do all of the following EXCEPT:
A. Ensure the quality systems in all facilities are in compliance with 21 CFR
820 regulations, as applicable
B. Include in the PMA submission a complete description of the device's
manufacturing, processing, packing, storage and installation methods
C. Provide written authorization to reference the Device Master File
information from a contracted facility
D. Submit quality system information only for the facility involved in the
design of the device ✔ Ans - D. Submit quality system information only for
the facility involved in the design of the device
A company is submitting a PMA for a permanent implant. The company has
performed biocompatibility testing based on ISO requirements and believes
the package is complete. Which of the following testing does the company
absolutely need to demonstrate long-term safety of its device:
A. Intracutaneous irritation
B. Genotoxicity
C. Acute toxicity
D. Carcinogenicity ✔ Ans - D. Carcinogenicity
A device that has just received marketing approval outside the US is to be
shipped from the US to a foreign distributor of Company XYZ. Company XYZ
contacts the foreign distributor, who confirms the product has not yet been
shipped and is still at its warehouse. Company XYZ requests the foreign
distributor return the device immediately. This activity described is an
example of a:
A. Market withdrawal
B. Stock recovery
C. Class I recall
D. Class III recall ✔ Ans - B. Stock recovery
All of the following are considered raw data in a preclinical study EXCEPT:
A. Final Pathology Report
B. Records of quarantine and animal receipt
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C. Animal data entered into animal chart
D. Computer printout derived from data transferred to computer media from
lab data sheets ✔ Ans - D. Computer printout derived from data
transferred to computer media from lab data sheets
Your Notified Body is classifying your device differently from you assessment.
After reviewing the classification rules, you are certain your classification is
correct; however, the Notified Body is not willing to reconsider. What is the
BEST strategy to resolve this situation?
A. Change Notified Body
B. Discuss with the Notified Body the reasons for your opinion
C. Ask the Notified Body to get an opinion from its Competent Authority
D. Sign the Declaration of Conformity and CE mark your device ✔ Ans - C.
Ask the Notified Body to get an opinion from its Competent Authority
The Clinical Investigation Plan (CIP) must include:
A. A clinical investigator's brochure
B. A clinical investigation protocol
C. The clinical investigator's qualifications
D. A copy of the informed consent form ✔ Ans - B. A clinical investigation
protocol
The marketing department asks your opinion regarding shelf-life labelling for
a new medical device to be able to place it on the market as soon as possible.
Which of the following should you advise the marketing department to do?
A. Do not put a "use-by" date on the device
B. Perform prospective accelerated aging studies for the minimum time
periods customers will accept
C. Label as they see fit, to be followed by retrospective studies using real time
experience
D. Find out what shelf life is used by the competition ✔ Ans - B. Perform
prospective accelerated aging studies for the minimum time periods
customers will accept
A clinical trial of a medical device can begin how many days after notification
is sent to the Competent Authority?
A. 30 days
B. 45 days
C. 60 daysPowered by TCPDF (www.tcpdf.org)
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