QA/QUALITY CONTROL EXAM 1 QUIZZES 1-4
QUESTIONS AND ANSWERS
Which of the 8 components of design control involves demonstrating the ability to
translate manufacturing from small scale to larger manufacturing scale?
a. Design Changes
b. Design Output
c. Design transfer
d. Design Validation
e. Design and Development Planning - Answers - c. Design transfer
Which specific Act added the requirement for Design Controls to medical device
manufacturing?
a. Medical Devices Regulatory Act of 1976
b. Safe Medical Devices Act of 1990
c. Medical Design Amendment of 1976
d. Design Control Amendment of 1976
e. Medical Devices Amendment of 1976 to FFDCA - Answers - b. Safe Medical Devices
Act of 1990
Failure to comply with any applicable provisions of FDA's Quality Systems Regulation
renders a device adulterated and ______________________ is (are) subject to
regulatory action.
a. The device and person responsible
b. The code and person responsible
c. The person responsible
d. The device and the code
e. The device and the legislator - Answers - a. The device and person responsible
The first letters of the 8 components of Design Control are:
a. DIORCVOT
b. VICTORDD
c. VVICTTRD
d. VVICTORD
e. VICTORRD - Answers - d. VVICTORD
"cGMPs for pharmaceuticals are found in CFR21 part ___, while the equivalent quality
systems regulations for devices are in CFR21 part ____."
a. 211:620
b. 211:820
c. 210:600
d. 210:800
, e. 211:80 - Answers - b. 211:820
Which of these information will be found in both device history record and device master
record?
a. Quantity manufactured
b. Production flow diagram
c. Dates of manufacture
d. A sample label with the batch number indicated
e. Release documentation - Answers - b. Production flow diagram
"Of the main systems making up the quality systems that are the focus of an FDA's
CDRH compliance inspection, which occupies the central and most important position?"
a. Management
b. Data Controls
c. "Records, Documents,Change Control"
d. Facilities and Equipment
e. Production and Process - Answers - a. Management
Which device is least likely to be required to comply with quality systems regulations
during its development stage?
a. A heart pump
b. A pacemaker
c. A kit that uses a patient's urine to test for pregnancy
d. An artificial pancreas which dispenses insulin
e. A robot that performs surgery - Answers - c. A kit that uses a patient's urine to test for
pregnancy
A _______ filing is required if a new device is not substantially equivalent to other
devices that have been cleared through a ________ process.
a. pre-market notification:pre-market approval
b. 510k:520k
c. 510k:510k
d. pre-market approval:510k
e. 510k:pre-market approval - Answers - c. 510k:510k
What is not true of pre-market authorization?
a. required mostly of Class I medical devices
b. a pre-aproval inspection of the manufacturing facility is a requisite for approval
c. approval of PMA requires demonstration that device is safe and effective
d. methods for testing the device should be included in the marketing application
e. methods for building the device should be included in the marketing application -
Answers - a. required mostly of Class I medical devices
QUESTIONS AND ANSWERS
Which of the 8 components of design control involves demonstrating the ability to
translate manufacturing from small scale to larger manufacturing scale?
a. Design Changes
b. Design Output
c. Design transfer
d. Design Validation
e. Design and Development Planning - Answers - c. Design transfer
Which specific Act added the requirement for Design Controls to medical device
manufacturing?
a. Medical Devices Regulatory Act of 1976
b. Safe Medical Devices Act of 1990
c. Medical Design Amendment of 1976
d. Design Control Amendment of 1976
e. Medical Devices Amendment of 1976 to FFDCA - Answers - b. Safe Medical Devices
Act of 1990
Failure to comply with any applicable provisions of FDA's Quality Systems Regulation
renders a device adulterated and ______________________ is (are) subject to
regulatory action.
a. The device and person responsible
b. The code and person responsible
c. The person responsible
d. The device and the code
e. The device and the legislator - Answers - a. The device and person responsible
The first letters of the 8 components of Design Control are:
a. DIORCVOT
b. VICTORDD
c. VVICTTRD
d. VVICTORD
e. VICTORRD - Answers - d. VVICTORD
"cGMPs for pharmaceuticals are found in CFR21 part ___, while the equivalent quality
systems regulations for devices are in CFR21 part ____."
a. 211:620
b. 211:820
c. 210:600
d. 210:800
, e. 211:80 - Answers - b. 211:820
Which of these information will be found in both device history record and device master
record?
a. Quantity manufactured
b. Production flow diagram
c. Dates of manufacture
d. A sample label with the batch number indicated
e. Release documentation - Answers - b. Production flow diagram
"Of the main systems making up the quality systems that are the focus of an FDA's
CDRH compliance inspection, which occupies the central and most important position?"
a. Management
b. Data Controls
c. "Records, Documents,Change Control"
d. Facilities and Equipment
e. Production and Process - Answers - a. Management
Which device is least likely to be required to comply with quality systems regulations
during its development stage?
a. A heart pump
b. A pacemaker
c. A kit that uses a patient's urine to test for pregnancy
d. An artificial pancreas which dispenses insulin
e. A robot that performs surgery - Answers - c. A kit that uses a patient's urine to test for
pregnancy
A _______ filing is required if a new device is not substantially equivalent to other
devices that have been cleared through a ________ process.
a. pre-market notification:pre-market approval
b. 510k:520k
c. 510k:510k
d. pre-market approval:510k
e. 510k:pre-market approval - Answers - c. 510k:510k
What is not true of pre-market authorization?
a. required mostly of Class I medical devices
b. a pre-aproval inspection of the manufacturing facility is a requisite for approval
c. approval of PMA requires demonstration that device is safe and effective
d. methods for testing the device should be included in the marketing application
e. methods for building the device should be included in the marketing application -
Answers - a. required mostly of Class I medical devices
