RAC Devices Practice Exam Questions and Answers 100% Correct
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Course
RAC Devices
Institution
RAC Devices
RAC Devices Practice Exam Questions and Answers 100% CorrectRAC Devices Practice Exam Questions and Answers 100% CorrectRAC Devices Practice Exam Questions and Answers 100% CorrectRAC Devices Practice Exam Questions and Answers 100% Correctand Answers 100% Correct
A medical device manufacturer i...
A medical device manufacturer is preparing a submission that requires a
Declaration of Conformity with design control requirements. What type of
submission is the manufacturer preparing to submit to FDA?
0 A PMA
1 A Special 510(k),
2 An Individual Device Exemption (IDE),
3 An Annual Report for a PMA - ANSWER-A Special 510(k)
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? - ANSWER-Contact the review division to determine whether a 510(k)
or PMA should be prepared.
, A company is submitting a PMA for a permanent implant. The company has
performed biocompatibility testing based on ISO requirements and believes
the package is complete. Which of the following testing does the company
absolutely need to demonstrate long-term safety of its device:
0 Intracutaneous irritation,
1 Genotoxicity,
2 Acute toxicity,
3 Carcinogenicity - ANSWER-Carcinogenicity
If a device fails to comply with any paragraph of the QSR is it adulterated? -
ANSWER-Yes
What source should the regulatory professional consult to determine when a
product's patent and exclusivity will expire? - ANSWER-The Orange Book
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? - ANSWER-Negotiate with
the review division.
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