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NEW QUESTION 45
A company is considering the development of a medical device similar to those already available. Which of the following should be evaluated FIRST when developing a clinical evaluation document?

• A. Literature search
• B. Clinical investigations
• C. Adverse event reports
• D. Clinical experience

Answer: B

NEW QUESTION 46
According to ICH, which of the following components of study information is NOT required in a clinical study report?

• A. Randomization scheme and codes
• B. Detailed CV of all investigators
• C. List of lECs or lRBs
• D. Protocol and protocol amendments

Answer: B

NEW QUESTION 47
Following the introduction of a new regulation, an evaluation of the company's products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

• A. Contact the trade association for advice.
• B. Request a permanent waiver from the new regulation.
• C. Prepare documents for the files.
• D. Communicate with the relevant internal departments.

Answer: D

NEW QUESTION 48
Which of the following statements regarding export regulations for an approved product is CORRECT?

• A. The product must not be sold or offered for sale in domestic commerce.
• 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 in accord with the specifications of the foreign purchaser.
• D. The product must not be labeled on the outside of the shipping package that it is intended for export.

Answer: B

NEW QUESTION 49
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