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 - Answers -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 - Answers -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) - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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. - Answers -A. Notify the
manufacturer and request the label be changed to include Swedish.
A manufacturer is developing bioresorbable plug and delivery devices sold together as
a single kit. The bioresorbable plug is placed in the femoral artery to close a puncture
site after an angioplasty procedure. The manufacturer has determined through testing
the plug is resorbed after 90 days. What is the device's classification?
A. Class IIb device per Annex IX, Rule 6 as it is "wholly or mainly absorbed"
B. Class IIa device per Annex IX, Rule 6 as the device is used for transient use and is
not used in the central
circulatory system
C. Class III device per Annex IX, Rule 8 as it is "wholly or mainly absorbed"
D. Class III device per Annex IX, Rule 7 as it is "wholly or mainly absorbed" - Answers -
C. Class III device per Annex IX, Rule 8 as it is "wholly or mainly absorbed"
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 - Answers -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 - Answers -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) - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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 - Answers -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. - Answers -A. Notify the
manufacturer and request the label be changed to include Swedish.
A manufacturer is developing bioresorbable plug and delivery devices sold together as
a single kit. The bioresorbable plug is placed in the femoral artery to close a puncture
site after an angioplasty procedure. The manufacturer has determined through testing
the plug is resorbed after 90 days. What is the device's classification?
A. Class IIb device per Annex IX, Rule 6 as it is "wholly or mainly absorbed"
B. Class IIa device per Annex IX, Rule 6 as the device is used for transient use and is
not used in the central
circulatory system
C. Class III device per Annex IX, Rule 8 as it is "wholly or mainly absorbed"
D. Class III device per Annex IX, Rule 7 as it is "wholly or mainly absorbed" - Answers -
C. Class III device per Annex IX, Rule 8 as it is "wholly or mainly absorbed"
