RAPS Practice Test Questions and
answers graded A+ passed
D. Re-consent all improperly consented subjects - correct answer ✔✔ A 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
A. Auditor independence has not been ensured - correct answer ✔✔ 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
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 -
correct answer ✔✔ 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 (PMOA)
D. Submit quality system information only for the facility involved in the design of the device -
correct answer ✔✔ 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
D. Carcinogenicity - correct answer ✔✔ 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
B. Stock recovery - correct answer ✔✔ 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
D. Computer printout derived from data transferred to computer media from lab data sheets -
correct answer ✔✔ All of the following are considered raw data in a preclinical study EXCEPT:
A. Final Pathology Report
B. Records of quarantine and animal receipt
C. Animal data entered into animal chart
D. Computer printout derived from data transferred to computer media from lab data sheets
C. Ask the Notified Body to get an opinion from its Competent Authority - correct answer ✔✔
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
B. A clinical investigation protocol - correct answer ✔✔ The Clinical Investigation Plan (CIP) must
include:
A. A clinical investigator's brochure
B. A clinical investigation protocol
answers graded A+ passed
D. Re-consent all improperly consented subjects - correct answer ✔✔ A 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
A. Auditor independence has not been ensured - correct answer ✔✔ 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
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 -
correct answer ✔✔ 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 (PMOA)
D. Submit quality system information only for the facility involved in the design of the device -
correct answer ✔✔ 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
D. Carcinogenicity - correct answer ✔✔ 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
B. Stock recovery - correct answer ✔✔ 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
D. Computer printout derived from data transferred to computer media from lab data sheets -
correct answer ✔✔ All of the following are considered raw data in a preclinical study EXCEPT:
A. Final Pathology Report
B. Records of quarantine and animal receipt
C. Animal data entered into animal chart
D. Computer printout derived from data transferred to computer media from lab data sheets
C. Ask the Notified Body to get an opinion from its Competent Authority - correct answer ✔✔
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
B. A clinical investigation protocol - correct answer ✔✔ The Clinical Investigation Plan (CIP) must
include:
A. A clinical investigator's brochure
B. A clinical investigation protocol
