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NEW QUESTION 43
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?
Answer: B
NEW QUESTION 44
Under which of the following circumstances would a regulatory authority require a more detailed premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data than would normally apply to an IVD device of that risk class?
Answer: D
NEW QUESTION 45
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?
QC records for batch release.B. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product.C. Ask that the regulatory authority provide the actual product subject to the complaint.D. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product.
Answer: D
NEW QUESTION 46
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
Answer: D
NEW QUESTION 47
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
Answer: C
NEW QUESTION 48
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