FDA All Practice_2 Test Bank Final Exam Questions &
Answers || Most Recent Exam Actual Complete Real Exam
Questions And Correct Answers (Verified Answers) Already
Graded A+ | Guaranteed Success!! Newest Exam | Just
Released 2026-2027
Which of the following is true regarding
FDA's MDR program?
A. It is not a mandatory program for hospitals.
B. It requires the manufacturer to report deaths and serious injuries.
C. It does not require the report of serious injury due to malfunction.
D. It requires physicians to alert FDA of device malfunctions in their personal
practice.
B. It requires the manufacturer to report deaths and serious injuries
A. This is required by the MDR regulation. 21 CFR 803.30
B. Tills is the primary requirement of MDR 21 CFR 803.50
C. An MDR does require reporting to FDA of serious injuries resulting from
malfunctions. 21 CFR 803.50
D. An MDR does not require physicians to report device malfunctions in their
personal practice.
,A personal deodorant manufacturer is required to do all of the following
EXCEPT:
A. comply with GMP
B. state the place of business on the label.
C. list the quantity of contents on the label.
D. comply with export regulations when
exporting product.
A. comply with GMP
A. Compliance to GMP is recommended, but not required for cosmetics.
FD&C Act, Section 602(b)
B. This is required by the regulations. Fair Packaging and Labeling Act, Section
4(a)
C. An accurate statement of the quantity is required. Fair Packaging and
Labeling Act, Section 4(a)
D. The export regulations govern drug, devices and cosmetics. FD&C Act,
Section 801 (c)
,During an FDA post-submission meeting, the regulatory affairs practitioner
should attempt to accomplish all of the following EXCEPT:
A identify the individual with primary responsibility for the review.
B. attempt to reach agreement on acceptability of data.
C. limit the amount of additional study required.
D. provide testimonials from investigators.
D. provide testimonials from investigators.
A. Knowing the reviewer will help expedite responses to any inquiries for
additional information.
B. If more studies are needed, can expedite to provide data required.
C. If more studies are needed, have FDA agree on the minimum number.
D. FDA makes its approval decision on basis of adequate and well controlled
studies, not anecdotal statements. 21 CFR 314.126
, The regulatory affairs practitioner's company manufacturers a product which
requires a power source. All of the following US associations could assist in
obtaining the information necessary for compliance with European standards
EXCEPT the:
A. Advanced Medical Technology Association.
B. National Electrical Manufacturers Association.
C. American National Standards Institute.
D. American Society for Testing and Materials.
D. American Society for Testing and Materials.
A. This represents domestic manufacturers of medical devices and diagnostic
products; gathers and disseminates information concerning US and
international developments.
B. This represents manufacturers concerned with quality and reliability of
electrical products.
C. This serves as a clearinghouse for safety, engineering, electrical and
industrial standards, representing the US internationally.
D. This establishes voluntary standard testing methods for materials, products,
systems and services; electrical sources not involved.
Answers || Most Recent Exam Actual Complete Real Exam
Questions And Correct Answers (Verified Answers) Already
Graded A+ | Guaranteed Success!! Newest Exam | Just
Released 2026-2027
Which of the following is true regarding
FDA's MDR program?
A. It is not a mandatory program for hospitals.
B. It requires the manufacturer to report deaths and serious injuries.
C. It does not require the report of serious injury due to malfunction.
D. It requires physicians to alert FDA of device malfunctions in their personal
practice.
B. It requires the manufacturer to report deaths and serious injuries
A. This is required by the MDR regulation. 21 CFR 803.30
B. Tills is the primary requirement of MDR 21 CFR 803.50
C. An MDR does require reporting to FDA of serious injuries resulting from
malfunctions. 21 CFR 803.50
D. An MDR does not require physicians to report device malfunctions in their
personal practice.
,A personal deodorant manufacturer is required to do all of the following
EXCEPT:
A. comply with GMP
B. state the place of business on the label.
C. list the quantity of contents on the label.
D. comply with export regulations when
exporting product.
A. comply with GMP
A. Compliance to GMP is recommended, but not required for cosmetics.
FD&C Act, Section 602(b)
B. This is required by the regulations. Fair Packaging and Labeling Act, Section
4(a)
C. An accurate statement of the quantity is required. Fair Packaging and
Labeling Act, Section 4(a)
D. The export regulations govern drug, devices and cosmetics. FD&C Act,
Section 801 (c)
,During an FDA post-submission meeting, the regulatory affairs practitioner
should attempt to accomplish all of the following EXCEPT:
A identify the individual with primary responsibility for the review.
B. attempt to reach agreement on acceptability of data.
C. limit the amount of additional study required.
D. provide testimonials from investigators.
D. provide testimonials from investigators.
A. Knowing the reviewer will help expedite responses to any inquiries for
additional information.
B. If more studies are needed, can expedite to provide data required.
C. If more studies are needed, have FDA agree on the minimum number.
D. FDA makes its approval decision on basis of adequate and well controlled
studies, not anecdotal statements. 21 CFR 314.126
, The regulatory affairs practitioner's company manufacturers a product which
requires a power source. All of the following US associations could assist in
obtaining the information necessary for compliance with European standards
EXCEPT the:
A. Advanced Medical Technology Association.
B. National Electrical Manufacturers Association.
C. American National Standards Institute.
D. American Society for Testing and Materials.
D. American Society for Testing and Materials.
A. This represents domestic manufacturers of medical devices and diagnostic
products; gathers and disseminates information concerning US and
international developments.
B. This represents manufacturers concerned with quality and reliability of
electrical products.
C. This serves as a clearinghouse for safety, engineering, electrical and
industrial standards, representing the US internationally.
D. This establishes voluntary standard testing methods for materials, products,
systems and services; electrical sources not involved.
