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NEW QUESTION 26 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 experience
• C. Adverse event reports
• D. Clinical investigations

Answer: D   NEW QUESTION 27 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?

• A. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
• B. The manufacturer's experience level with the type of IVD medical device is limited.
• C. The device incorporates well-established technology that is already present in the market.
• D. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.

Answer: B   NEW QUESTION 28 Which of the following situations does NOT require rapid communication to regulatory authorities?

• A. A major safety finding from a newly completed animal carcinogenicity study
• B. A lack of efficacy with a medicinal product used in treating a life-threatening disease
• C. A statistically significant increase in the number of deaths in an animal dose finding study
• D. A clinically important increase in the rate of occurrence of an "expected." but serious ADR

Answer: D   NEW QUESTION 29 ......