RAC Exam Questions and Answers (Graded A)RAC Exam Questions and Answers (Graded A)RAC Exam Questions and Answers (Graded A)RAC Exam Questions and Answers (Graded A)RAC Exam Questions and Answers (Graded A)
What source should the regulatory professional consult to determine when a product's patent ...
What source should the regulatory professional consult to determine when a
product's patent and exclusivity will expire?
A. Federal Register
B. The Orange Book
C. Patent and Trademark Office
D. Copyright Office - ANSWER-B. The Orange Book
An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
D. BLA or 510(k) - ANSWER-D. BLA or 510(k)
,If a device failure is occurring with greater than expected frequency and
investigation of the problem implicates improper use by the end user, which
of the following should occur?
A. The labeling is revised
B. The product is recalled
C. The product is redesigned
D. A dear Dr letter is issued - ANSWER-A. The labeling is revised
What class of medical devices has no regulatory qual system requirement?
A. Class I
B. Class II
C. Class III
D. Class IV - ANSWER-A. Class I
Which of the following is TRUE regarding an adulterated medical device?
A. The device fails to comply with any paragraph of the QSR
, B. The device has misleading or incorrect information
C. The device lists FDA approved on the cleared 510k
D. The device does not have a cleared 510k - ANSWER-A. The device fails to
comply with any paragraph of the QSR
Which of the following medical device entities is required to register its
establishment?
A. Contract packager
B. Domestic Distributer
C. Medical device salvager
D. Reprocessing facility - ANSWER-D. Reprocessing facility
When should the manufacturer of a Class III medical device expect to have
an FDA premarket approval Inspection?
A. Within IDE application
B. After IDE Study Phase II
C. Prior to PMA approval
D. Within 2 years following PMA approval - ANSWER-C. Prior to PMA approval
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