Device RAC Exam UPDATED ACTUAL Questions and CORRECT Answers
Which division has primary jurisdiction over a vascular C. CDRH
graft with an antibiotic based on primary mode of action?
In this combination of a device and a drug, the primary mode of action is that of
A. CDER the vascular graft (device). The antibiotic is supportive in this case.
B. CBER
C. CDRH
D. OCP
A company wants to modify its legally marketed device A. Special 510(k)
such that the modification does not affect the intended
use or alter the fundamental scientific technology of the A Special 510(k) is allowed if a modification to the legally marketed device is
device. If the design outputs of the modified device meet being made that relies on compliance with design controls, including design
the design input requirements, this change would be best validation. The incentive provided for manufacturers to choose this option is that
filed as a(n): ODE intends to process special 510(k)s within 30 days of receipt. See the CDRH
guidance published in 1998 entitled The New 510(k) Paradigm - Alternate
A. Special 510(k) Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k)
Under the statutory violations, failure to meet 510(k) C. Misbranded
requirements for a device that is required to have a 510(k)
and is in commercial distribution is considered to be: A marketed device that needs a 510(k) for commercialization but failed to comply
with the requirements is considered to be Misbranded. See the FD&C Act, 502(o).
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent
A company's competitor is marketing a Class II suture A. This requires a new 510(k) since significant change in product instructions might
which dissolves during the third week of use. The affect efficacy.
company's current product has to be removed by a
physician. However, a change in weaving configuration A new intended use requires a 510(k) clearance.
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
,A physician reports to a manufacturer that a patient was C. 30 calendar days
hospitalized with acute sepsis after treatment with an
approved device. This side effect is not listed in the Serious injury must be reported within 30 days even if it is expected and stated in
package insert. This event must be reported by the the IFU
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
A handling and storage system for medical devices must C. Procedures for product receipt and transfer
always include:
Procedures for receipt and transfer of products are required; see 21 CFR
A. Procedures for rotation of stock 820.150(b).
B. Separate rooms or cages for release and quarantine
products
C. Procedures for product receipt and transfer
D. Environmentally controlled areas for products with
shelf life
You have modified your 510(k) cleared device with a D. None of the above.
special 510(k). In which of the following cases would you
need to create a new listing for the device? According to 21 CFR 807.22(b), a separate form FDA-2892 shall be submitted for
each device or device class listed with the FDA. Devices having variations in
A. You have added new sizes and shapes in the product physical characteristics such as size, package, shape, color or composition should
portfolio. be considered to be one device: Provided, The variation does not change the
B. You have changed the material composition of the function or intended use of the device.
device.
C. You have changed the package of the device.
D. None of the above.
Per the QSR, when an investigation of a complaint is C. Changes in procedures correcting quality problems
conducted, all of the following are requirements for
inclusion in investigation record EXCEPT: The requirement is for corrective and preventative action and only needed if
corrective action was taken per investigation. See Sec. 820.198. Complaint files.
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
The QSR calls for finished device mfgers to carry out all B. Annual audits of operations
of the following EXCEPT:
Under CFR 820.3(t), an audit must be performed at defined intervals and at
A. Quality audits conducted by individuals who don't sufficient frequency to determine that quality system activities comply with quality
have direct responsibility for operation being audited system procedures that these procedures are implemented effectively and that
B. Annual audits of operations procedures are suitable to achieve quality system objectives.
C. Document the dates and results of quality audits and
re-audits
D. Have findings reviewed by management responsible
for the matters audited
, According to the Quality System Regulations, re-testing A. Device history record
and re-evaluation of nonconforming devices after rework
activities must be documented in the: This contains the dates of manufacture, the quantity manufactured, the quantity
released for distribution, control numbers used and the acceptance records
A. Device history record which demonstrate the device is manufactured in accordance with the DMR. See
B. Device master record 21 CFR 820.184.
C. Quality manual
D. Design history file
Under 21 CFR 812, the IDE regulation, which of the B. Investigator shall report device use without informed consent to sponsor and
following statements is FALSE? IRB within 10 working days after use occurs.
A. Investigator shall report withdrawal of approval by the The investigator shall report device use without obtaining informed consent to the
IRB to sponsor within 5 working days. sponsor and the reviewing IRB within 5 working days after the use occurs. See 21
B. Investigator shall report device use without informed CFR 812.150(a)(5).
consent to sponsor and IRB within 10 working days after
use occurs.
C. The sponsor shall notify FDA within 30 working days of
the completion or termination of an investigation for a sig
risk device.
D. An investigator shall submit to the sponsor and IRB a
report of any unanticipated adverse device effect within
10 working days after the investigator first learns of the
effect.
When a manufacturer is performing design validation D. Translation of device design into production specifications
activities, which element is NOT included as a
requirement under device design validation section of the Translation of device design into production specifications is covered under
QSR? 820.30(h) Design transfer.
A. Conformance to defined user needs and intended
uses
B. Testing of production units under actual or simulated
use conditions
C. Software validation
D. Translation of device design into production
specifications
A manufacturer which of the following must file an IDE C. A custom device being studied for safety and effectiveness in support of
before conducting a human clinical study? commercial marketing
A. A device in commercial distribution before 28 May 1976 While a custom device may be studied in humans without an IDE, if its safety and
when used or investigated in accordance with its efficacy are being studied in support of commercial marketing, an IDE must be
indications in labeling in effect at that time filed; see 21 CFR 812.2(c)(7).
B. A device intended solely for veterinary use
C. A custom device being studied for safety and
effectiveness in support of commercial marketing
D. A device in commercial distribution before 28 May 1976
when used or investigated in accordance with its
indications in labeling in effect at that time and intended
solely for veterinary use
Which division has primary jurisdiction over a vascular C. CDRH
graft with an antibiotic based on primary mode of action?
In this combination of a device and a drug, the primary mode of action is that of
A. CDER the vascular graft (device). The antibiotic is supportive in this case.
B. CBER
C. CDRH
D. OCP
A company wants to modify its legally marketed device A. Special 510(k)
such that the modification does not affect the intended
use or alter the fundamental scientific technology of the A Special 510(k) is allowed if a modification to the legally marketed device is
device. If the design outputs of the modified device meet being made that relies on compliance with design controls, including design
the design input requirements, this change would be best validation. The incentive provided for manufacturers to choose this option is that
filed as a(n): ODE intends to process special 510(k)s within 30 days of receipt. See the CDRH
guidance published in 1998 entitled The New 510(k) Paradigm - Alternate
A. Special 510(k) Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k)
Under the statutory violations, failure to meet 510(k) C. Misbranded
requirements for a device that is required to have a 510(k)
and is in commercial distribution is considered to be: A marketed device that needs a 510(k) for commercialization but failed to comply
with the requirements is considered to be Misbranded. See the FD&C Act, 502(o).
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent
A company's competitor is marketing a Class II suture A. This requires a new 510(k) since significant change in product instructions might
which dissolves during the third week of use. The affect efficacy.
company's current product has to be removed by a
physician. However, a change in weaving configuration A new intended use requires a 510(k) clearance.
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
,A physician reports to a manufacturer that a patient was C. 30 calendar days
hospitalized with acute sepsis after treatment with an
approved device. This side effect is not listed in the Serious injury must be reported within 30 days even if it is expected and stated in
package insert. This event must be reported by the the IFU
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
A handling and storage system for medical devices must C. Procedures for product receipt and transfer
always include:
Procedures for receipt and transfer of products are required; see 21 CFR
A. Procedures for rotation of stock 820.150(b).
B. Separate rooms or cages for release and quarantine
products
C. Procedures for product receipt and transfer
D. Environmentally controlled areas for products with
shelf life
You have modified your 510(k) cleared device with a D. None of the above.
special 510(k). In which of the following cases would you
need to create a new listing for the device? According to 21 CFR 807.22(b), a separate form FDA-2892 shall be submitted for
each device or device class listed with the FDA. Devices having variations in
A. You have added new sizes and shapes in the product physical characteristics such as size, package, shape, color or composition should
portfolio. be considered to be one device: Provided, The variation does not change the
B. You have changed the material composition of the function or intended use of the device.
device.
C. You have changed the package of the device.
D. None of the above.
Per the QSR, when an investigation of a complaint is C. Changes in procedures correcting quality problems
conducted, all of the following are requirements for
inclusion in investigation record EXCEPT: The requirement is for corrective and preventative action and only needed if
corrective action was taken per investigation. See Sec. 820.198. Complaint files.
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
The QSR calls for finished device mfgers to carry out all B. Annual audits of operations
of the following EXCEPT:
Under CFR 820.3(t), an audit must be performed at defined intervals and at
A. Quality audits conducted by individuals who don't sufficient frequency to determine that quality system activities comply with quality
have direct responsibility for operation being audited system procedures that these procedures are implemented effectively and that
B. Annual audits of operations procedures are suitable to achieve quality system objectives.
C. Document the dates and results of quality audits and
re-audits
D. Have findings reviewed by management responsible
for the matters audited
, According to the Quality System Regulations, re-testing A. Device history record
and re-evaluation of nonconforming devices after rework
activities must be documented in the: This contains the dates of manufacture, the quantity manufactured, the quantity
released for distribution, control numbers used and the acceptance records
A. Device history record which demonstrate the device is manufactured in accordance with the DMR. See
B. Device master record 21 CFR 820.184.
C. Quality manual
D. Design history file
Under 21 CFR 812, the IDE regulation, which of the B. Investigator shall report device use without informed consent to sponsor and
following statements is FALSE? IRB within 10 working days after use occurs.
A. Investigator shall report withdrawal of approval by the The investigator shall report device use without obtaining informed consent to the
IRB to sponsor within 5 working days. sponsor and the reviewing IRB within 5 working days after the use occurs. See 21
B. Investigator shall report device use without informed CFR 812.150(a)(5).
consent to sponsor and IRB within 10 working days after
use occurs.
C. The sponsor shall notify FDA within 30 working days of
the completion or termination of an investigation for a sig
risk device.
D. An investigator shall submit to the sponsor and IRB a
report of any unanticipated adverse device effect within
10 working days after the investigator first learns of the
effect.
When a manufacturer is performing design validation D. Translation of device design into production specifications
activities, which element is NOT included as a
requirement under device design validation section of the Translation of device design into production specifications is covered under
QSR? 820.30(h) Design transfer.
A. Conformance to defined user needs and intended
uses
B. Testing of production units under actual or simulated
use conditions
C. Software validation
D. Translation of device design into production
specifications
A manufacturer which of the following must file an IDE C. A custom device being studied for safety and effectiveness in support of
before conducting a human clinical study? commercial marketing
A. A device in commercial distribution before 28 May 1976 While a custom device may be studied in humans without an IDE, if its safety and
when used or investigated in accordance with its efficacy are being studied in support of commercial marketing, an IDE must be
indications in labeling in effect at that time filed; see 21 CFR 812.2(c)(7).
B. A device intended solely for veterinary use
C. A custom device being studied for safety and
effectiveness in support of commercial marketing
D. A device in commercial distribution before 28 May 1976
when used or investigated in accordance with its
indications in labeling in effect at that time and intended
solely for veterinary use
