DEVICE RAC ACTUAL EXAM PAPER 2026
QUESTIONS WITH ANSWERS GRADED A+
◍ A GMP audit/inspection against the requirements of 21 CFR 2 10/211 may
include auditing of all of the following EXCEPT:
A. Complaint files
B. Qualifications of consultants
C. Pre-clinical laboratory(ies)
D. SOPs.
Answer: B?
◍ 510(k) requirements.
Answer: Criteria that must be met to demonstrate that a medical device is
substantially equivalent to a legally marketed device.
◍ IVD devices.
Answer: IVD devices are included in the types of products covered by
GHTF's guidance on labeling.
◍ ISO 13485, ISO 14971.
Answer: Standards widely used by international regulatory agencies as the
foundation for assessing a company's ability to manufacture medical
devices.
◍ Clinical trial notification.
Answer: A clinical trial of a medical device can begin 60 days after
notification is sent to the Competent Authority.
◍ Risk analysis.
Answer: Risk analysis, where applicable.
◍ A company's supplier of the active drug substance for the company's OTC
drug product informs the company that the supplier will be moving their
, production of the drug substance from the current plant to a new
manufacturing plant in another state in 6 months. The supplier states that all
manufacturing processes will remain the same and the specificationswill not
change. The company intends to qualify the change suitably. How should
the company report the change to FDA?
A. The change only needs to be reported in an annual report because the
company will qualify the change and the supplier said the process and
specification won't change
B. The change should be reported in a pre-approval supplement (e.g., CBE,
CBE-30 or full pre-approval supplement) because it is a change to the drug
substance manufacturing location
C. The change does not have to be reported because it is an OTC drug
D. Not enough information.
Answer: B?
◍ Subacute toxicity testing should be performed:
A. In two rodent species
B. In one rodent and one non-rodent species
C. For a minimum of two weeks
D. For a minimum of six months.
Answer: C?
◍ Legacy device.
Answer: A device that was designed and developed prior to a company's
implementation of cybersecurity policies and cannot be reasonably protected
against current cybersecurity threats.
◍ Compare the approved text with the product label.
Answer: Check the product label against the officially approved text for
discrepancies.
◍ According to the QSR, Quality Audits must accomplish the following:A)
Meet the same requirements of the original GMP B) Evaluate if the Quality
System is in compliance with the QSRC) Determine the effectiveness of the
Quality SystemD) Focus on Design Controls and the CAPA systemE) B and
, C aboveF) A and D above.
Answer: E
◍ While examining complaint files, a quality assurance practitioner notices
that there are several complaints of microbial contamination of one product
lot. To determine the possible source of the problem, what records should be
examined first?
A. Sterilization and water system validations
B. Environmental monitoring
C. Raw material/supplier records
D. Batch or product history record.
Answer: A?
◍ During a monitoring visit, the sponsor discovers that an investigator had
used a device in a clinical investigation without obtaining informed consent
from the subject. Which of the following should the regulatory affairs
professional do?
A. Predate the informed consent with a memo to the site file
B. Contact the patient to obtain the informed consent immediately
C. Ensure that the study director from the sponsor discusses the issue with
the investigator
D. Report the protocol deviation to the IRB.
Answer: C?
◍ From a pre-clinical viewpoint, which of the following constitute pre-clinical
activities in medical device development?A) Animal use testing to validate
the design of your deviceB) Bench testing to verify that your design
performs as designedC) Biocompatibility/Toxicity testingD)
Functional/Safety/Performance testingE) All of the above.
Answer: E
◍ A company wants to modify its device such that there is a major change to
the fundamental scientific technology of the device. The FDA has published
a guidance on this technology and special controls have been established.
This change would be best filed as a(n):
QUESTIONS WITH ANSWERS GRADED A+
◍ A GMP audit/inspection against the requirements of 21 CFR 2 10/211 may
include auditing of all of the following EXCEPT:
A. Complaint files
B. Qualifications of consultants
C. Pre-clinical laboratory(ies)
D. SOPs.
Answer: B?
◍ 510(k) requirements.
Answer: Criteria that must be met to demonstrate that a medical device is
substantially equivalent to a legally marketed device.
◍ IVD devices.
Answer: IVD devices are included in the types of products covered by
GHTF's guidance on labeling.
◍ ISO 13485, ISO 14971.
Answer: Standards widely used by international regulatory agencies as the
foundation for assessing a company's ability to manufacture medical
devices.
◍ Clinical trial notification.
Answer: A clinical trial of a medical device can begin 60 days after
notification is sent to the Competent Authority.
◍ Risk analysis.
Answer: Risk analysis, where applicable.
◍ A company's supplier of the active drug substance for the company's OTC
drug product informs the company that the supplier will be moving their
, production of the drug substance from the current plant to a new
manufacturing plant in another state in 6 months. The supplier states that all
manufacturing processes will remain the same and the specificationswill not
change. The company intends to qualify the change suitably. How should
the company report the change to FDA?
A. The change only needs to be reported in an annual report because the
company will qualify the change and the supplier said the process and
specification won't change
B. The change should be reported in a pre-approval supplement (e.g., CBE,
CBE-30 or full pre-approval supplement) because it is a change to the drug
substance manufacturing location
C. The change does not have to be reported because it is an OTC drug
D. Not enough information.
Answer: B?
◍ Subacute toxicity testing should be performed:
A. In two rodent species
B. In one rodent and one non-rodent species
C. For a minimum of two weeks
D. For a minimum of six months.
Answer: C?
◍ Legacy device.
Answer: A device that was designed and developed prior to a company's
implementation of cybersecurity policies and cannot be reasonably protected
against current cybersecurity threats.
◍ Compare the approved text with the product label.
Answer: Check the product label against the officially approved text for
discrepancies.
◍ According to the QSR, Quality Audits must accomplish the following:A)
Meet the same requirements of the original GMP B) Evaluate if the Quality
System is in compliance with the QSRC) Determine the effectiveness of the
Quality SystemD) Focus on Design Controls and the CAPA systemE) B and
, C aboveF) A and D above.
Answer: E
◍ While examining complaint files, a quality assurance practitioner notices
that there are several complaints of microbial contamination of one product
lot. To determine the possible source of the problem, what records should be
examined first?
A. Sterilization and water system validations
B. Environmental monitoring
C. Raw material/supplier records
D. Batch or product history record.
Answer: A?
◍ During a monitoring visit, the sponsor discovers that an investigator had
used a device in a clinical investigation without obtaining informed consent
from the subject. Which of the following should the regulatory affairs
professional do?
A. Predate the informed consent with a memo to the site file
B. Contact the patient to obtain the informed consent immediately
C. Ensure that the study director from the sponsor discusses the issue with
the investigator
D. Report the protocol deviation to the IRB.
Answer: C?
◍ From a pre-clinical viewpoint, which of the following constitute pre-clinical
activities in medical device development?A) Animal use testing to validate
the design of your deviceB) Bench testing to verify that your design
performs as designedC) Biocompatibility/Toxicity testingD)
Functional/Safety/Performance testingE) All of the above.
Answer: E
◍ A company wants to modify its device such that there is a major change to
the fundamental scientific technology of the device. The FDA has published
a guidance on this technology and special controls have been established.
This change would be best filed as a(n):
