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RAC Exam Questions and Answers
Latest 2026
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 Ans: 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) Ans: D. BLA or 510(k)
Which of the following is TRUE regarding an adulterated
medical device?
A. The device fails to comply with any paragraph of the
QSR
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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 Ans: 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 Ans: 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 Ans: C. Prior
to PMA approval
Devices exempt from premarket notification are:
© 2025 All rights reserved
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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 Ans: C.
Most Class I devices and some Class II devices
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 Ans: D. Traditional or
abbreviated
The quality assurance manager of a small company with
12 employees is the company's only internal auditor and
has been performing all internal quality system audits for
3 years. this does not meet requirements for performing
internal qual system audits because:
A. Auditor independence has not been ensured.
B. no one in the company qualified to train
© 2025 All rights reserved
RAC Exam Questions and Answers
Latest 2026
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 Ans: 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) Ans: D. BLA or 510(k)
Which of the following is TRUE regarding an adulterated
medical device?
A. The device fails to comply with any paragraph of the
QSR
© 2025 All rights reserved
, 2 | Page
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 Ans: 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 Ans: 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 Ans: C. Prior
to PMA approval
Devices exempt from premarket notification are:
© 2025 All rights reserved
, 3 | Page
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 Ans: C.
Most Class I devices and some Class II devices
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 Ans: D. Traditional or
abbreviated
The quality assurance manager of a small company with
12 employees is the company's only internal auditor and
has been performing all internal quality system audits for
3 years. this does not meet requirements for performing
internal qual system audits because:
A. Auditor independence has not been ensured.
B. no one in the company qualified to train
© 2025 All rights reserved
