RAC DEVICE CERTIFICATION REVIEW 2026
QUESTIONS WITH SOLUTIONS GRADED A+
●● A company wants to modify its legally marketed device such that the
modification does not affect the intended use or alter the fundamental
scientific technology of the device. If the design outputs of the modified
device meet the design input requirements, this change would be best
filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k). Answer: A
●● Under the statutory violations, failure to meet 510(k) requirements
for a device that is required to have a 510(k) and is in commercial
distribution is considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent. Answer: C
●● A company's competitor is marketing a Class II suture which
dissolves during the third week of use. The company's current product
has to be removed by a physician. However, a change in weaving
,configuration gives this product the same dissolving time as the
competitor's. When can the company's new suture be marketed?
A. This requires a new 510(k) since significant change in product
instructions might
affect efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change. Answer: A
●● Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers. Answer: D
●● A physician reports to a manufacturer that a patient was hospitalized
with acute sepsis after treatment with an approved device. This side
effect is not listed in the package insert. This event must be reported by
the manufacturer to FDA no later than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
,D. The next quarterly or annual report. Answer: C
●● 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 typically occurs?
A. The labeling is revised.
B. The product is recalled.
C. The product is redesigned.
D. A "Dear Doctor" letter is issued.. Answer: A
●● A handling and storage system for medical devices must always
include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for receipt and transfer of product
D. Environmentally controlled areas for products with shelf life.
Answer: C
●● You have modified your 510(k) cleared device with a special 510(k).
In which of the following cases would you need to create a new listing
for the device?
A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
, D. None of the above.. Answer: D
●● According to the QSR, when an investigation of a complaint is
conducted all of the following are requirements for inclusion in the
record of the investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant. Answer: C
●● The QSR calls for the manufacturer of finished devices to carry out
all of the following EXCEPT:
A. Conduct quality audits by individuals who do not have direct
responsibility for the operation being audited
B. Audit operations annually
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the matters
audited. Answer: B
●● Which of the following subsystems is NOT required by FDA in order
to implement and maintain a Quality System?
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
QUESTIONS WITH SOLUTIONS GRADED A+
●● A company wants to modify its legally marketed device such that the
modification does not affect the intended use or alter the fundamental
scientific technology of the device. If the design outputs of the modified
device meet the design input requirements, this change would be best
filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k). Answer: A
●● Under the statutory violations, failure to meet 510(k) requirements
for a device that is required to have a 510(k) and is in commercial
distribution is considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent. Answer: C
●● A company's competitor is marketing a Class II suture which
dissolves during the third week of use. The company's current product
has to be removed by a physician. However, a change in weaving
,configuration gives this product the same dissolving time as the
competitor's. When can the company's new suture be marketed?
A. This requires a new 510(k) since significant change in product
instructions might
affect efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change. Answer: A
●● Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers. Answer: D
●● A physician reports to a manufacturer that a patient was hospitalized
with acute sepsis after treatment with an approved device. This side
effect is not listed in the package insert. This event must be reported by
the manufacturer to FDA no later than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
,D. The next quarterly or annual report. Answer: C
●● 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 typically occurs?
A. The labeling is revised.
B. The product is recalled.
C. The product is redesigned.
D. A "Dear Doctor" letter is issued.. Answer: A
●● A handling and storage system for medical devices must always
include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for receipt and transfer of product
D. Environmentally controlled areas for products with shelf life.
Answer: C
●● You have modified your 510(k) cleared device with a special 510(k).
In which of the following cases would you need to create a new listing
for the device?
A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
, D. None of the above.. Answer: D
●● According to the QSR, when an investigation of a complaint is
conducted all of the following are requirements for inclusion in the
record of the investigation EXCEPT:
A. The dates and results of the investigation
B. The nature and details of the complaint
C. Changes in procedures correcting quality problems
D. Any reply to the complainant. Answer: C
●● The QSR calls for the manufacturer of finished devices to carry out
all of the following EXCEPT:
A. Conduct quality audits by individuals who do not have direct
responsibility for the operation being audited
B. Audit operations annually
C. Document the dates and results of quality audits and re-audits
D. Have findings reviewed by management responsible for the matters
audited. Answer: B
●● Which of the following subsystems is NOT required by FDA in order
to implement and maintain a Quality System?
A. Production and process controls
B. Test and control article characterization
C. Packaging and labeling controls
