Online Access Free RAC-US Practice Test

What is the LAST stage in the development of a quality risk management process for a medical device?

• A.Risk reduction
• B.Risk analysis
• C.Risk acceptance
• D.Risk evaluation

A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

• A.Label the product for use in appropriate populations.
• B.Promote off-label use to a carefully selected patient population.
• C.Delay product launch until required studies are completed.
• D.Educate patients and healthcare providers on how to use the product

A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

• A.Until the product has been discontinued from marketing in all ICH regions
• B.For at least two years after the last approval of an application in an ICH region
• C.Three years after the last clinical study site was supplied with investigational drugs
• D.For a minimum of 10 years after completion of the clinical study

A company receives multiple complaints regarding the text included on a recently launched product's label. What action should the regulatory affairs professional take FIRST?

• A.Recommend an immediate product recall.
• B.Inform the production team.
• C.Compare the approved text with the product label
• D.Notify the regulatory authority.

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