Free RAPS RAC-GS Exam Dumps Questions & Answers

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.  Product literature
• C.  Essential principles
• D.  Risk analysis

The intermediate manufacturing process was changed during development of a pharmaceutical. The change may impact the API specification. Which functional area is responsible for the final approval of the change?

• A.  Regulatory
• B.  Quality
• C.  Production
• D.  Analytical

After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

• A.  Discontinue the project.
• B.  Redesign the device.
• C.  Perform another risk-benefit analysis.
• D.  Add a warning in the IFU.

As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?

• A.  Site license
• B.  Import license
• C.  Product license
• D.  Export license

Which of the following statements regarding export regulations for an approved product is CORRECT?

• A.  The product must not be in conflict with the laws of the country to which it is intended forexport.
• B.  The product must not be labeled on the outside of the shipping package that it is intendedfor export.
• C.  The product must not be sold or offered for sale in domestic commerce.
• D.  The product must not be in accord with the specifications of the foreign purchaser.