RAC EXAM |ACTUAL QUESTIONS AND VERIFIED
ANSWERS|BRAND NEW 2026-2027
UPDATE|GRADED A+
Question 1
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
CORRECT ANSWER
B. The Orange Book
Question 2
An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
D. BLA or 510(k)
CORRECT ANSWER
D. BLA or 510(k)
1
,Question 3
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
CORRECT ANSWER
A. The device fails to comply with any paragraph of the QSR
Question 4
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
CORRECT ANSWER
D. Reprocessing facility
Question 5
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
2
, C. Prior to PMA approval
D. Within 2 years following PMA approval
CORRECT ANSWER
C. Prior to PMA approval
Question 6
Devices exempt from premarket notification are:
A. All Class I devices
B. Some Class I devices
C. Most Class I devices and some Class II devices
D. All Class I devices and some Class II devices
CORRECT ANSWER
C. Most Class I devices and some Class II devices
Question 7
A company intends to add an indication for use to a 510k device that is currently being
marketed, but not yet distributed. What type of submission is most appropriate?
A. PMA
B. IDE
C. special 510k
D. Traditional or abbreviated
CORRECT ANSWER
D. Traditional or abbreviated
3
ANSWERS|BRAND NEW 2026-2027
UPDATE|GRADED A+
Question 1
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
CORRECT ANSWER
B. The Orange Book
Question 2
An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
D. BLA or 510(k)
CORRECT ANSWER
D. BLA or 510(k)
1
,Question 3
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
CORRECT ANSWER
A. The device fails to comply with any paragraph of the QSR
Question 4
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
CORRECT ANSWER
D. Reprocessing facility
Question 5
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
2
, C. Prior to PMA approval
D. Within 2 years following PMA approval
CORRECT ANSWER
C. Prior to PMA approval
Question 6
Devices exempt from premarket notification are:
A. All Class I devices
B. Some Class I devices
C. Most Class I devices and some Class II devices
D. All Class I devices and some Class II devices
CORRECT ANSWER
C. Most Class I devices and some Class II devices
Question 7
A company intends to add an indication for use to a 510k device that is currently being
marketed, but not yet distributed. What type of submission is most appropriate?
A. PMA
B. IDE
C. special 510k
D. Traditional or abbreviated
CORRECT ANSWER
D. Traditional or abbreviated
3
