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
Which of the following criteria is MOST appropriate to define the animal species needed for the pre-clinical toxicity testing of a biotechnology product?
A. Proposed dose and volume of administration
B. Biological activity with species and/or tissue specificity
C. Immunochemical and functional tests
D. Proposed product route and frequency of administration
The requirements for document control are located in which of the following documents?
A. ICH guidelines
B. IEC 60601
C. ISO 13485
D. WHO guidelines
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
A. Plasma fractionation
B. Product distribution
C. Individual plasma donation
D. Plasma pooling
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
A. Perform either an identification study or a non-clinical qualification study.
B. Perform both identification and non-clinical qualification studies concurrently.
C. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
D. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
Which of the following double-blind clinical trial designs would be MOST appropriate for a Phase III study with a new product intended to treat an acute life-threatening disease with less than optimal available therapy?
A. Active-controlled
B. Cross-over
C. Dose-ranging
D. Placebo-controlled
A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?
A. Negotiate with colleagues and the authority to find a better time.
B. Insist that key personnel be available for the inspection.
C. Inform the authority that the time is not suitable and request a new time
D. Arrange for an inspection without all intended personnel.
A company is currently marketing an implantable orthopedic medical device. The RandD department is planning to change the material used for the implant. The RandD department states that the change does not impact the safety and effectiveness of the product.
What action should the regulatory affairs professional take FIRST?
A. No action is needed in this situation.
B. Prepare regulatory submissions that detail the medical device's change in materials.
C. Review the content of change and supporting data for the equivalency with the current material.
D. Write a memo to file since the change does not impact product safety and effectiveness.
A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?
A. In vitro studies show the product to be superior.
B. Government survey data indicate the product is superior.
C. Results of a three-year, post-market patient survey indicate the product is superior.
D. Results of adequate, well-controlled comparative clinical trial show the product is superior.
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. The device is an updated version of a compliant device from the same manufacturer and contains no substantive change.
B. Internationally recognized standards are available to cover the main aspects of the device and have been used by the manufacturer.
C. The manufacturer's experience level with the type of IVD medical device is limited.
D. The device incorporates well-established technology that is already present in the market.
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