DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH GUARANTEED PASS 2024 LATEST UPDATE
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Course
DEVICE RAC
Institution
DEVICE RAC
DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH GUARANTEED PASS 2024 LATEST UPDATE
The initial importer of a medical device MUST:
A. Report incidents in which a device may have caused or contributed to a death or serious injury
B. Maintain quality assurance files
C. Share responsibility for submi...
DEVICE RAC EXAM QUESTIONS AND
ANSWERS WITH GUARANTEED PASS
2024 LATEST UPDATE
The initial importer of a medical device MUST:
A. Report incidents in which a device may have caused or contributed to a death or
serious injury
B. Maintain quality assurance files
C. Share responsibility for submittals with other distributors
D. Report device malfunctions in an annual report - 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 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
D. An internal audit program - Answer ✔ B
A legally marketed device to which equivalence is drawn in a premarketing submission
is known as the:
A. Comparator device
B. Predecessor device
C. Predicate device
D. Substantially equivalent device - Answer ✔ C
A humanitarian device exemption differs from a traditional PMA in that:
A. It does not require compliance with QSR.
B. Non-clinical data are not required.
C. Effectiveness data are not required. - Answer ✔ C
Removal of a distributed product for a reason NOT subject to legal action by FDA is
known as:
A. Product recall
B. Stock recovery
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