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.
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?
A. Fishbone analysis
B. Failure modes, effects, and criticality analysis
C. Fault tree analysis
D. Quality by design analysis
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation. However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
A. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
B. Inform the internal departments to redesign the product to comply with this requirement.
C. Inform the regulatory authority that such a requirement is not applicable to the product.
D. Notify senior management that the product cannot be registered.
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.
Which of the following statements regarding the off-label use of drugs is CORRECT?
A. Although the regulatory authority reviews and approves drugs for specific indications, theapproval does not limit the use of those drugs in clinical practice.
B. The regulatory authority does not restrict physician prescribing for off-label indications orregulate the manufacturer's promotion for such use.
C. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
D. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing accessto much needed drugs and devices.
GHTF recommends that the medical device manufacturer define the scope of the clinical evaluation based on which of the following?
A. Instructions for use
B. Risk analysis
C. Product literature
D. Essential principles
During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?
A. The minimum number of attendees necessary to address the issues
B. All senior management from the main office
C. As many as government attendees
D. As many as required by international standards
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 is NOT required to be included in a marketing application?
A. Final printed label
B. Quality, safety, and efficacy Information
C. Administrative forms
D. Evidence of fee payment
What is the LAST stage in the development of a quality risk management process for a medical device?
A. Risk analysis
B. Risk reduction
C. Risk acceptance
D. Risk evaluation
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