RAPS Practice Test Questions
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 -
☑️ 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 -
☑️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 (PMOA) -
☑️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 -
☑️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 -
☑️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 -
☑️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 -
☑️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 -
☑️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 -
☑️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 -
☑️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 days
D. As soon as Ethical Committee approval is received -
☑️C. 60 days
A US manufacturer CE marks its Class IIa medical device and labels it in English, French, German,
Italian and Spanish. A French based distributor has a contract with the company to distribute, market
and supply the product in the UK, France, Germany, Italy and Spain. A hospital in Sweden calls the
distributor requesting a regular supply of the product. The distributor should:
A. Notify the manufacturer and request the label be changed to include Swedish.
B. Supply the product as labelled since English is understood in Sweden.
C. Not supply into Sweden until a local distributor is appointed.
D. Translate the label into Swedish and ship the product. -
☑️A. Notify the manufacturer and request the label be changed to include Swedish.
A company is planning to launch its new List B (Annex II) IVD. Which of the following actions should
the regulatory professional recommend to the company?
A. Obtain Notified Body approval of the technical documentation and the quality system
B. CE mark the device using the "self-certification" route
C. Ensure that the Notified Body conducts batch release and examination of the dossier design
D. Conduct performance evaluation in accordance with common technical specifications -
☑️A. Obtain Notified Body approval of the technical documentation and the quality system
Which of the following BEST demonstrates conformance with the Essential Requirements for a Class
IIa device?
A. Test lab results that are authorised by the state Competent Authority
B. Testing conducted by the manufacturer showing conformance to harmonised standards
C. It is not necessary to show conformance through testing because application of standards is
voluntary
D. Testing conducted by the manufacturer showing conformance to international or national standards.
-
☑️B. Testing conducted by the manufacturer showing conformance to harmonised standards
A mfger of a permanently implanted active device is seeking guidance on conformance to Essential
Requirements. What advice would you give?
A. Conformance to 90/385/EEC is needed
B. Conformance to 93/42/EEC is needed
C. Conformance to 98/79/EC is needed
D. For active implantable devices, CE Mark is not required -
☑️A. Conformance to 90/385/EEC is necessary
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 -
☑️ 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 -
☑️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 (PMOA) -
☑️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 -
☑️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 -
☑️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 -
☑️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 -
☑️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 -
☑️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 -
☑️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 -
☑️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 days
D. As soon as Ethical Committee approval is received -
☑️C. 60 days
A US manufacturer CE marks its Class IIa medical device and labels it in English, French, German,
Italian and Spanish. A French based distributor has a contract with the company to distribute, market
and supply the product in the UK, France, Germany, Italy and Spain. A hospital in Sweden calls the
distributor requesting a regular supply of the product. The distributor should:
A. Notify the manufacturer and request the label be changed to include Swedish.
B. Supply the product as labelled since English is understood in Sweden.
C. Not supply into Sweden until a local distributor is appointed.
D. Translate the label into Swedish and ship the product. -
☑️A. Notify the manufacturer and request the label be changed to include Swedish.
A company is planning to launch its new List B (Annex II) IVD. Which of the following actions should
the regulatory professional recommend to the company?
A. Obtain Notified Body approval of the technical documentation and the quality system
B. CE mark the device using the "self-certification" route
C. Ensure that the Notified Body conducts batch release and examination of the dossier design
D. Conduct performance evaluation in accordance with common technical specifications -
☑️A. Obtain Notified Body approval of the technical documentation and the quality system
Which of the following BEST demonstrates conformance with the Essential Requirements for a Class
IIa device?
A. Test lab results that are authorised by the state Competent Authority
B. Testing conducted by the manufacturer showing conformance to harmonised standards
C. It is not necessary to show conformance through testing because application of standards is
voluntary
D. Testing conducted by the manufacturer showing conformance to international or national standards.
-
☑️B. Testing conducted by the manufacturer showing conformance to harmonised standards
A mfger of a permanently implanted active device is seeking guidance on conformance to Essential
Requirements. What advice would you give?
A. Conformance to 90/385/EEC is needed
B. Conformance to 93/42/EEC is needed
C. Conformance to 98/79/EC is needed
D. For active implantable devices, CE Mark is not required -
☑️A. Conformance to 90/385/EEC is necessary
