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NEW MODIFIED RAPS PRACTICE TEST
ACTUAL QUESTIONS AND ANSWERS
NEWLY MODIFIED GRADED A+
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 -- ANSWER--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?
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, Page 2
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) -- 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
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
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, Page 3
D. Submit quality system information only for the facility involved in the
design of the device -- ANSWER--D. Submit quality system information only
for the facility involved in the design of the device
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 -- ANSWER--B. A clinical
investigation protocol
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 -- ANSWER--D. Carcinogenicity
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, Page 4
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 -- ANSWER--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
C. Animal data entered into animal chart
D. Computer printout derived from data transferred to computer media from lab
data sheets -- ANSWER--D. Computer printout derived from data
transferred to computer media from lab data sheets
Page 4 of 49
NEW MODIFIED RAPS PRACTICE TEST
ACTUAL QUESTIONS AND ANSWERS
NEWLY MODIFIED GRADED A+
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 -- ANSWER--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?
Page 1 of 49
, Page 2
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) -- 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
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
Page 2 of 49
, Page 3
D. Submit quality system information only for the facility involved in the
design of the device -- ANSWER--D. Submit quality system information only
for the facility involved in the design of the device
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 -- ANSWER--B. A clinical
investigation protocol
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 -- ANSWER--D. Carcinogenicity
Page 3 of 49
, Page 4
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 -- ANSWER--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
C. Animal data entered into animal chart
D. Computer printout derived from data transferred to computer media from lab
data sheets -- ANSWER--D. Computer printout derived from data
transferred to computer media from lab data sheets
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