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 - ✔✔1 Contact the
review division to determine whether a 510(k) or PMA should be prepared
,The Quality System Regulation calls for finished device manufacturers to carry
out all of the following
EXCEPT
0 Quality audits conducted by individuals who do ,
1 Annual audits of operations,
2 Documenting the dates and results of quality audit,
3 Having findings reviewed by management responsible - ✔✔Annual audits
of operations
What does the 510 (k) number, such as K130001, mean, and what does it encode?
A. The first two digits designate the calendar year the submission was received
B. The last four digits represent the submission number for the year
C. Designates the number of submissions made by a company - ✔✔A and B
,You are the regulatory compliance expert in the organization and are required to
suggest the mechanism to successfully achieve conformity to QMS, in regard to
identifying potential compliance issues. Which of the following is the LEAST
effective option?
0 Conducting internal audits against applicable re,
1 Regularly reviewing FDA Warnings Letters issued ,
2 Listening to podcasts on medical device industry compliance trends
3 Using a CAPA system, investigating potential int - ✔✔Listening to podcasts
on medical device industry compliance trends.
A regulatory professional is negotiating with the FDA on a product's final
labeling. The company's management is adamant about including a claim in the
labeling, while the FDA is proposing a more restrictive claim. What is the
regulatory professional's BEST course of action?
, 0 Accept the FDAs proposed labeling.,
1 Contact the centers director.,
2 Contact the ombudsman.,
3 Negotiate with the review division. - ✔✔3 Negotiate with the review division.
When a manufacturer is performing design validation activities, which element
is NOT included as a requirement under QSR's device design validation section?
0 Conformance to defined user needs and intended u,
1 Testing production units under actual or simula,
2 Software validation and risk analysis, where app,
3 Translation of device design into production specifications - ✔✔Translation
of device design into production specifications.
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?
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