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RAPS Regulatory Affairs Certification (RAC) US Sample Questions (Q31-Q36):

NEW QUESTION # 31
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

A. Examine decisions made about similar products in Country Y to propose the classification of the product.B. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.C. Submit the product for review as a pharmaceutical product in Country Y.D. Apply for review of the additional part of the product as a pharmaceutical product in Country

Answer: D


NEW QUESTION # 32
One month prior to the anticipated approval date for your product, the marketing application that you submitted to a major regulatory authority has become the subject of an advisory committee meeting of experts convened by the regulatory authority. The advisory committee members unanimously vote not to approve your product because of a safety concern. Two days after the advisory committee meeting, the regulatory authority requests additional information to support the safety of your product. Assuming you have no additional data to provide, which of the following would be your MOST appropriate response to the regulatory authority's request?

A. "We have no additional information to provide at this time because we have already provided everything needed to support our product's approval."B. "We disagree with the advisory committee's decision because the committee neglected the thorough safety analysis that we provided."C. "We have no additional information to provide at this time, but we can perform an additional analysis for a specific safety concern, if necessary."D. "Given the advisory committee's unanimous decision, we know that the product will not be approved, and additional data will not make any difference."

Answer: C


NEW QUESTION # 33
What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

A. Request documentation from the sub-contractor.B. Request an inspection from a regulatory authority.C. Document and perform audits.D. Ask the vendor to take responsibility.

Answer: C


NEW QUESTION # 34
A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D 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. Write a memo to file since the change does not impact product safety and effectiveness.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. No action is needed in this situation.

Answer: C


NEW QUESTION # 35
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

A. Malfunction protection operated correctlyB. Deficiency of a device found by the user prior to patient useC. Adverse event caused by patient conditionsD. Malfunction occurring before the end of service life of the medical device

Answer: C


NEW QUESTION # 36
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