DEVICE RAC EXAM 2
QUESTIONS AND VERIFIED
CORRECT ANSWERS
GRADED A+ [LATEST] 100%
GUARANTEED PASS
Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE?
A. An investigator shall report to the sponsor within 5 working days a withdrawal of approval by
the IRB.
B. The investigator shall report device use without obtaining informed consent to the sponsor
and the reviewing IRB within 10 working days after the use occurs.
C. The sponsor shall notify FDA within 30 working days of the completion or
termination of an investigation for a significant risk device.
D. An investigator shall submit to the sponsor and IRB a report of any unanticipated
adverse device effect within 10 working days after the investigator first learns of the
effect. - CORRECT ANSWER-B
When design validation activities are being performed by a manufacturer, which element is NOT
included as a requirement under device design validation section of the QSR?
A. Conformance to defined user needs and intended uses
B. Testing of production units under actual or simulated use conditions
C. Software validation
,D. Translation of device design into production specifications - CORRECT ANSWER-D
A manufacturer of which of the following must file an IDE before conducting a human clinical
study?
A. A device in commercial distribution before 28 May 1976 when used or investigated in
accordance with its indications in labeling in effect at that time
B. A device intended solely for veterinary use
C. A custom device being studied for safety and effectiveness in support of commercial
marketing
D. A device in commercial distribution before 28 May 1976 when used or investigated in
accordance with its indications in labeling in effect at that time and intended solely for
veterinary use - CORRECT ANSWER-C
Which one of the following statements is NOT true with respect to both INDs and IDEs for
significant-risk products?
A. The investigational product must be manufactured in full compliance with cGMP.
B. Clinical studies must be reviewed and approved by an Institutional Review Board.
C. The IND or IDE goes into effect 30 days after FDA receives the application, unless
FDA notifies the sponsor otherwise.
D. The application must include an environmental impact statement that contains a claim
for categorical exclusion or an environmental assessment. - CORRECT ANSWER-A
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 - CORRECT 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 - CORRECT 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 - CORRECT 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) - CORRECT 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 - CORRECT 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. - CORRECT 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 - CORRECT 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
QUESTIONS AND VERIFIED
CORRECT ANSWERS
GRADED A+ [LATEST] 100%
GUARANTEED PASS
Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE?
A. An investigator shall report to the sponsor within 5 working days a withdrawal of approval by
the IRB.
B. The investigator shall report device use without obtaining informed consent to the sponsor
and the reviewing IRB within 10 working days after the use occurs.
C. The sponsor shall notify FDA within 30 working days of the completion or
termination of an investigation for a significant risk device.
D. An investigator shall submit to the sponsor and IRB a report of any unanticipated
adverse device effect within 10 working days after the investigator first learns of the
effect. - CORRECT ANSWER-B
When design validation activities are being performed by a manufacturer, which element is NOT
included as a requirement under device design validation section of the QSR?
A. Conformance to defined user needs and intended uses
B. Testing of production units under actual or simulated use conditions
C. Software validation
,D. Translation of device design into production specifications - CORRECT ANSWER-D
A manufacturer of which of the following must file an IDE before conducting a human clinical
study?
A. A device in commercial distribution before 28 May 1976 when used or investigated in
accordance with its indications in labeling in effect at that time
B. A device intended solely for veterinary use
C. A custom device being studied for safety and effectiveness in support of commercial
marketing
D. A device in commercial distribution before 28 May 1976 when used or investigated in
accordance with its indications in labeling in effect at that time and intended solely for
veterinary use - CORRECT ANSWER-C
Which one of the following statements is NOT true with respect to both INDs and IDEs for
significant-risk products?
A. The investigational product must be manufactured in full compliance with cGMP.
B. Clinical studies must be reviewed and approved by an Institutional Review Board.
C. The IND or IDE goes into effect 30 days after FDA receives the application, unless
FDA notifies the sponsor otherwise.
D. The application must include an environmental impact statement that contains a claim
for categorical exclusion or an environmental assessment. - CORRECT ANSWER-A
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 - CORRECT 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 - CORRECT 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 - CORRECT 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) - CORRECT 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 - CORRECT 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. - CORRECT 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 - CORRECT 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
