DEVICE RAC EXAM QUESTIONS AND ANSWERS WITH
COMPLETE SOLUTION/ BRAND NEW 2024/ 100% PASS
GUARANTEED
1. Which division would have primary jurisdiction over a vascular graft with an antibiotic
based on primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP:
2. Premarket Notification is required of manufacturers when introducing:
A. New label size
B. New Class II devices
C. A change in product name
D. Additional manufacturing sites:
3. All of the following are considered General Controls under the FD&C Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device:
4. According to the QSR, suitable maintenance of equipment is necessary to ensure
that manufacturing specifications are met. All of the following are requirements for the
equipment EXCEPT:
A. A written maintenance schedule is required
B. Allowable tolerances are posted on or near the equipment
C. Maintenance must be performed at least annually
D. Inspections of equipment must be documented:
5. Which of the following devices would be regulated by CBER?
A) Warming device
B) Blood pressure cuff
C) HIV diagnostic test kit
D) Capillary blood collection tube:
6. For a medical Device, what is NOT a responsibility of the US Agent for a Foreign
Establishment?
,A) Report adverse events under the Medical Device Reporting regulation
B) Assisting FDA in communications with the foreign establishment,
C) Responding to questions concerning the foreign establishment's products that are
imported or offered for import into the United States, and
D) Assisting FDA in scheduling inspections of the foreign establishment.:
7. A company wants to modify its legally marketed device such that the mod- ification
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):
8. 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:
9. A company's competitor is marketing a Class II suture which dissolves dur- ing 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:
10. Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers:
, 11. 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:
12. 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.:
13. 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:
14. 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
15. 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 investi- gation 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
16. 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
COMPLETE SOLUTION/ BRAND NEW 2024/ 100% PASS
GUARANTEED
1. Which division would have primary jurisdiction over a vascular graft with an antibiotic
based on primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP:
2. Premarket Notification is required of manufacturers when introducing:
A. New label size
B. New Class II devices
C. A change in product name
D. Additional manufacturing sites:
3. All of the following are considered General Controls under the FD&C Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device:
4. According to the QSR, suitable maintenance of equipment is necessary to ensure
that manufacturing specifications are met. All of the following are requirements for the
equipment EXCEPT:
A. A written maintenance schedule is required
B. Allowable tolerances are posted on or near the equipment
C. Maintenance must be performed at least annually
D. Inspections of equipment must be documented:
5. Which of the following devices would be regulated by CBER?
A) Warming device
B) Blood pressure cuff
C) HIV diagnostic test kit
D) Capillary blood collection tube:
6. For a medical Device, what is NOT a responsibility of the US Agent for a Foreign
Establishment?
,A) Report adverse events under the Medical Device Reporting regulation
B) Assisting FDA in communications with the foreign establishment,
C) Responding to questions concerning the foreign establishment's products that are
imported or offered for import into the United States, and
D) Assisting FDA in scheduling inspections of the foreign establishment.:
7. A company wants to modify its legally marketed device such that the mod- ification
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):
8. 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:
9. A company's competitor is marketing a Class II suture which dissolves dur- ing 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:
10. Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers:
, 11. 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:
12. 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.:
13. 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:
14. 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
15. 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 investi- gation 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
16. 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
