RAC FINAL PAPER 2026 QUESTIONS WITH FULL
ANSWERS
◉ 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 for the sponsor discusses the issue
with the investigator
D. Report the protocol deviation to the IRB. Answer: C
◉ The regulatory affairs professional should perform all of the
following prior to submitting a PMA to FDA EXCEPT:
A. Prepare criteria for the MDR report
B. Prepare a brief statement of reasons for noncompliance with
regulation
C. Identify all omissions in PMA content
D. Review, organize and check adequacy of data pertaining to safety
and efficacy
evaluation. Answer: A
,◉ All Class I medical devices are subject to the following
requirements EXCEPT:
A. Device Master File (DMF)
B. Design History File (DHF)
C. Device History Record (DHR)
D. Medical Device Reporting (MDR). Answer: B
◉ MDUFMA authorizes FDA-accredited persons to inspect qualified
manufacturers of:
A. Class I and II devices
B. Class I devices only
C. Class II devices only
D. Class II and III device. Answer: D
◉ MDUFMA authorized 3rd party establishment inspections under
carefully prescribed conditions. All the following prescribed
conditions about 3rd party establishment inspections are true
EXCEPT:
A. The establishment must market at least one device in the US and
must market a device
"in one or more foreign countries."
B. Manufactures of class III devices are not eligible for 3rd party
inspections.
, C. In order to be eligible, an establishment's most recent inspection
must be NAI or VAI.
D. Establishments are required to notify FDA of the person it intends
to use and FDA
must agree to the selection.. Answer: B
◉ FDA has sent a warning letter citing mislabeling of a small
manufacturer's
artificial knee device. The regulatory affairs professional should first
contact the:
A. Compliance Branch in their district
B. Orthopedic Branch Chief in the CDRH Office of Device Evaluation
C. Division of Small Manufacturers, International and Consumer
Assistance (DSMICA)
in CDRH.
D. CDRH Ombudsman. Answer: A
◉ Inspections of device components received from a supplier may
frequently reveal product quality deficiencies. To avoid these
instances, the supplier should first have:
A. Expert GMP knowledge
B. Clear and precise specifications from the manufacturer
C. Detailed knowledge of the manufacturer's operations
ANSWERS
◉ 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 for the sponsor discusses the issue
with the investigator
D. Report the protocol deviation to the IRB. Answer: C
◉ The regulatory affairs professional should perform all of the
following prior to submitting a PMA to FDA EXCEPT:
A. Prepare criteria for the MDR report
B. Prepare a brief statement of reasons for noncompliance with
regulation
C. Identify all omissions in PMA content
D. Review, organize and check adequacy of data pertaining to safety
and efficacy
evaluation. Answer: A
,◉ All Class I medical devices are subject to the following
requirements EXCEPT:
A. Device Master File (DMF)
B. Design History File (DHF)
C. Device History Record (DHR)
D. Medical Device Reporting (MDR). Answer: B
◉ MDUFMA authorizes FDA-accredited persons to inspect qualified
manufacturers of:
A. Class I and II devices
B. Class I devices only
C. Class II devices only
D. Class II and III device. Answer: D
◉ MDUFMA authorized 3rd party establishment inspections under
carefully prescribed conditions. All the following prescribed
conditions about 3rd party establishment inspections are true
EXCEPT:
A. The establishment must market at least one device in the US and
must market a device
"in one or more foreign countries."
B. Manufactures of class III devices are not eligible for 3rd party
inspections.
, C. In order to be eligible, an establishment's most recent inspection
must be NAI or VAI.
D. Establishments are required to notify FDA of the person it intends
to use and FDA
must agree to the selection.. Answer: B
◉ FDA has sent a warning letter citing mislabeling of a small
manufacturer's
artificial knee device. The regulatory affairs professional should first
contact the:
A. Compliance Branch in their district
B. Orthopedic Branch Chief in the CDRH Office of Device Evaluation
C. Division of Small Manufacturers, International and Consumer
Assistance (DSMICA)
in CDRH.
D. CDRH Ombudsman. Answer: A
◉ Inspections of device components received from a supplier may
frequently reveal product quality deficiencies. To avoid these
instances, the supplier should first have:
A. Expert GMP knowledge
B. Clear and precise specifications from the manufacturer
C. Detailed knowledge of the manufacturer's operations
