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Recent Exam Actual Complete Real Exam Questions
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Released 2026-2027
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
Recent Exam Actual Complete Real Exam Questions
And Correct Answers (Verified Answers) Already
Graded A+ | Guaranteed Success!! Newest Exam | Just
Released 2026-2027
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
