RAPS RAC EXAM |ACTUAL QUESTIONS AND
VERIFIED ANSWERS|BRAND NEW 2026-2027
UPDATE|GRADED A+
Question 1
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
CORRECT ANSWER
D. Re-consent all improperly consented subjects
Question 2
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
CORRECT ANSWER
A. Auditor independence has not been ensured
1
,Question 3
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)
CORRECT ANSWER
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
Question 4
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
2
,CORRECT ANSWER
D. Submit quality system information only for the facility involved in the design of the
device
Question 5
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
CORRECT ANSWER
D. Carcinogenicity
Question 6
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
CORRECT ANSWER
B. Stock recovery
3
, Question 7
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
CORRECT ANSWER
D. Computer printout derived from data transferred to computer media from lab data
sheets
Question 8
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
CORRECT ANSWER
C. Ask the Notified Body to get an opinion from its Competent Authority
Question 9
The Clinical Investigation Plan (CIP) must include:
4
VERIFIED ANSWERS|BRAND NEW 2026-2027
UPDATE|GRADED A+
Question 1
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
CORRECT ANSWER
D. Re-consent all improperly consented subjects
Question 2
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
CORRECT ANSWER
A. Auditor independence has not been ensured
1
,Question 3
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)
CORRECT ANSWER
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
Question 4
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
2
,CORRECT ANSWER
D. Submit quality system information only for the facility involved in the design of the
device
Question 5
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
CORRECT ANSWER
D. Carcinogenicity
Question 6
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
CORRECT ANSWER
B. Stock recovery
3
, Question 7
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
CORRECT ANSWER
D. Computer printout derived from data transferred to computer media from lab data
sheets
Question 8
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
CORRECT ANSWER
C. Ask the Notified Body to get an opinion from its Competent Authority
Question 9
The Clinical Investigation Plan (CIP) must include:
4
