RAC DEVICES QUESTIONS WITH COMPLETE
SOLUTIONS
1993 Masstricht Treaty Correct Answers Broadened public
health from the national domain to areas of competence under
the EU's mission, which was extended to ensure a high level of
protection for consumers' health, safety, and economic interests,
as well as public health.
A clinical trial of a medical device can begin how many days
after notification is sent to the Competent Authority?
30 days,
45 days,
60 days,
As soon as Ethical Committee approval is received Correct
Answers 60 days
A company currently sells the third version of a non-implantable
medical device, which was introduced four years ago. The
company wishes to destroy the records of the second version.
Which of the following is CORRECT?
0 All records can be destroyed.,
1 The manufacturing records can be destroyed.,
2The sales records can be destroyed.,
3 No records can be destroyed. Correct Answers No records
can be destroyed
A company establishes a new medical device indication for its
consumer disposable products. The regulatory affairs
,professional is asked to give a 30-minute training session on
these products to sales representatives. Which of the following
subjects is the MOST important to discuss?
0 Labeling,
1 Regulatory application summary,
2 Risk management process,
3 Safety-related reporting Correct Answers Labeling
A company is developing a new medical device using
innovative technology. Which of the following is MOST critical
in working with regulatory authorities?
0 Documented agreement,
1 Frequent communication,
2 Early collaboration,
3 Follow-up meeting after submission Correct Answers
Frequent communication
A company is performing routine site monitoring of its pivotal
clinical study for a blood sugar meter and finds one site has not
consented one-third of its subjects properly . What is the FIRST
thing the company needs to do?
A.Stop the entire study
B. Inform FDA and ask for guidance
C. Re-train the study staff, including the principle investigator
D. Re-consent all improperly consented subjects Correct
Answers D Re-consent all improperly consented subjects
, A company receives multiple complaints regarding the text
included on a recently launched product's label. What action
should the regulatory professional take FIRST?
0 Recommend an immediate product recall.,
1 Compare the approved text with the product label,
2 Notify the regulatory authority.,
3 Inform the production team. Correct Answers Compare the
approved text with the product label.
A company wishes to expand existing labeling for a medical
device to include a new indication for use. What action should
the regulatory professional take FIRST?
0 Contact the review division to determine the co,
1 Contact the review division to determine whether a 510(k) or
PMA should be prepared,
2 Prepare a 510(k) premarket notification claiming,
3 Prepare a 510(k) premarket notification claiming Correct
Answers 1 Contact the review division to determine whether a
510(k) or PMA should be prepared
A device is being used on a regular basis for an indication
outside of the labeling. Is there any sharing of liability by a
physician when a device is used off-label?
0 True, 1 False Correct Answers False
A manufacturer sells 1,500 medical devices in the two months
following launch. A user, but not a patient, is seriously injured
SOLUTIONS
1993 Masstricht Treaty Correct Answers Broadened public
health from the national domain to areas of competence under
the EU's mission, which was extended to ensure a high level of
protection for consumers' health, safety, and economic interests,
as well as public health.
A clinical trial of a medical device can begin how many days
after notification is sent to the Competent Authority?
30 days,
45 days,
60 days,
As soon as Ethical Committee approval is received Correct
Answers 60 days
A company currently sells the third version of a non-implantable
medical device, which was introduced four years ago. The
company wishes to destroy the records of the second version.
Which of the following is CORRECT?
0 All records can be destroyed.,
1 The manufacturing records can be destroyed.,
2The sales records can be destroyed.,
3 No records can be destroyed. Correct Answers No records
can be destroyed
A company establishes a new medical device indication for its
consumer disposable products. The regulatory affairs
,professional is asked to give a 30-minute training session on
these products to sales representatives. Which of the following
subjects is the MOST important to discuss?
0 Labeling,
1 Regulatory application summary,
2 Risk management process,
3 Safety-related reporting Correct Answers Labeling
A company is developing a new medical device using
innovative technology. Which of the following is MOST critical
in working with regulatory authorities?
0 Documented agreement,
1 Frequent communication,
2 Early collaboration,
3 Follow-up meeting after submission Correct Answers
Frequent communication
A company is performing routine site monitoring of its pivotal
clinical study for a blood sugar meter and finds one site has not
consented one-third of its subjects properly . What is the FIRST
thing the company needs to do?
A.Stop the entire study
B. Inform FDA and ask for guidance
C. Re-train the study staff, including the principle investigator
D. Re-consent all improperly consented subjects Correct
Answers D Re-consent all improperly consented subjects
, A company receives multiple complaints regarding the text
included on a recently launched product's label. What action
should the regulatory professional take FIRST?
0 Recommend an immediate product recall.,
1 Compare the approved text with the product label,
2 Notify the regulatory authority.,
3 Inform the production team. Correct Answers Compare the
approved text with the product label.
A company wishes to expand existing labeling for a medical
device to include a new indication for use. What action should
the regulatory professional take FIRST?
0 Contact the review division to determine the co,
1 Contact the review division to determine whether a 510(k) or
PMA should be prepared,
2 Prepare a 510(k) premarket notification claiming,
3 Prepare a 510(k) premarket notification claiming Correct
Answers 1 Contact the review division to determine whether a
510(k) or PMA should be prepared
A device is being used on a regular basis for an indication
outside of the labeling. Is there any sharing of liability by a
physician when a device is used off-label?
0 True, 1 False Correct Answers False
A manufacturer sells 1,500 medical devices in the two months
following launch. A user, but not a patient, is seriously injured
