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RAC-US PDF DEMO:
QUESTION NO: 1
A company is developing a new medical device.
During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?
A. Concept development and validation
B. Concept development and early technical design
C. Early technical design and product release
D. Product release and validation
Answer: B
QUESTION NO: 2
Which of the following statements regarding export regulations for an approved product is
CORRECT?
A. The product must not be in accord with the specifications of the foreign purchaser.
B. The product must not be in conflict with the laws of the country to which it is intended for export.
C. The product must not be labeled on the outside of the shipping package that it is intended for export.
D. The product must not be sold or offered for sale in domestic commerce.
Answer: B
QUESTION NO: 3
A regulatory affairs professional has submitted a package for regulatory review.
According to the regulation, the regulatory authority will need to respond within 90 days of submission.
If there is no response after the deadline, what is the BEST approach?
A. Contact the regulatory authority, ask for clarification about the delay, and provide answers to any outstanding questions.
B. Contact the regulatory authority, ask for clarification about the delay, and demand a decision be made regarding the submission.
C. Contact the local political representative and ask for intervention with the regulatory authority to obtain a decision regarding the submission.
D. Contact the company legal representative in order to begin legal proceedings to enforce the regulatory authority's response time.
Answer: A
QUESTION NO: 4
During the review of a design dossier, the reviewer asks why the company has only carried out a top-down risk approach. The reviewer is referring to which of the following?
A. ISO 14971 risk analysis
B. Failure mode and effect analysis
C. Fault tree analysis
D. Hazard and operability study
Answer: A
QUESTION NO: 5
Who has the PRIMARY responsibility for recall of products with quality defects?
A. Consumer
B. Distributor
C. Manufacturer
D. Regulatory authority
Answer: C
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Updated: May 28, 2022