최신 RAC-US 무료덤프 - RAPS Regulatory Affairs Certification (RAC) US
During a routine review of promotional materials for a product, a regulatory affairs professional discovers an off-label indication. Which of the following would be the FIRST follow-up action for the regulatory affairs professional to take?
정답: D
Which of the following is MOST appropriate for the purpose of lot release of biologics?
정답: A
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?
정답: B
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?
정답: B
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?
정답: D
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?
정답: A
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
정답: D
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?
정답: D
Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?
정답: A
In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?
정답: A