DEVICE RAC COMPREHENSIVE STUDY
GUIDE 2026 FULL QUESTIONS AND
SOLUTIONS GRADED A+
◍ Under EU MDR, which document defines the methodology and scope for
generating clinical evidence throughout the device lifecycle?
A. Clinical Investigation Plan (CIP)
B. Summary of Safety and Clinical Performance (SSCP)
C. Clinical Evaluation Plan (CEP)
D. Postmarket Clinical Follow-Up (PMCF) Plan.
Answer: C. Clinical Evaluation Plan (CEP)
◍ Which of the following is NOT part of the General Safety and Performance
Requirements (GSPR) under IVDR?
A. Risk control measures
B. Labeling requirements
C. Economic feasibility
D. Performance evaluation.
Answer: C. Economic feasibility
◍ 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. None of the above.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 physical characteristics such as
, size, package, shape, color or composition should be considered to be one
device: Provided, The variation does not change the function or intended use
of the device.
◍ Under EU MDR, what is the typical frequency of notified body surveillance
audits for Class IIb devices?
A. Every 2 years
B. Once per product lifecycle
C. At least annually
D. Every 5 years.
Answer: C. At least annually
◍ An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
D. BLA or 510(k).
Answer: D. BLA or 510(k)IVDs can be submitted as a 510(k) under the
Food, Drug, and Cosmetic Act or a BLA under the Public Health Service
Act. Regulatory Reference: Public Health Service Act, Food, Drug, and
Cosmetic Act.
◍ According to the QSR, Design Outputs contain the following:A) Device
Master Record (DMR)B) The documentation from the last phase of the
complete Design Control processC) Test reports that support the Design
Inputs metD) All packaging and labeling associated with finished device E)
A and D above.
Answer: E) A and D aboveNOT RAC TEST STYLE QUESTION
◍ You are a German-based device manufacturer whose device is packaged in
Ireland and sold in the US through a US-based company. The 510(k) was
writtten by a contract organization. The label of our product may indicated
any of the following EXCEPT"
A. The principle place of business in the US
B. The packaging location address
, C. The address of the contractor who submitted the 510(k)
D. The address of the distributor.
Answer: C. The address of the contractor who submitted the
510(k)Regulatory Reference: FDCA 801(e)(i). Medical devices; name and
place of business of manufacturer, packer or distributor. (a) The label of a
device in package form shall specify conspicuously the name and place of
business of the manufacturer, packer or distributor.
◍ If your firm commercially distributes a Class III device subject to PMA
without an approved PMA, what is the statutory violation?A)
AdulterationB) Improper UseC) MisbrandingD) Idiocy.
Answer: A) Adulteration
◍ 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.
Answer: B. New Class II devices
◍ Design validation must:
A. Be performed using only simulations
B. Include testing under actual or simulated use conditions
C. Be conducted postmarket
D. Include supplier audits.
Answer: B. Include testing under actual or simulated use conditions
◍ Under EU MDR, which class of device typically requires clinical
investigation unless sufficient clinical evidence already exists?
A. Class I
B. Class IIa
C. Class IIb
D. Class III.
Answer: D. Class III
◍ Which mfgers must register their mfging facility with FDA?
, A. Component mfgers who sell only to device mfger using their components
B. Domestic (US) contract mfgers who do not directly distribute the final
product to the market
C. Domestic mfger of device being investigated under an IDE
D. Foreign mfgers shipping devices into US for sale in US.
Answer: D. Foreign mfgers shipping devices into the US for sale in the
USAll foreign mfgers making devices distributed in the US must register
with FDA.
◍ Which of the following is TRUE about the FDA's Global Unique Device
Identification Database (GUDID)?
A. It is private and accessible only to manufacturers
B. It stores both UDI-DI and UDI-PI data
C. It stores the static UDI-DI information for public access
D. It replaces the need for device listing with FDA.
Answer: C. It stores the static UDI-DI information for public access
◍ According to the Quality System Regulation, 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.
Answer: C. Maintenance must be performed at least annuallyQSR does not
specify "annually":Maintenance schedule. Each manufacturer shall establish
and maintain schedules for the adjustment, cleaning, and other maintenance
of equipment to ensure that manufacturing specifications are met.
maintenance activities, including the date and individual(s) performing the
maintenance activities, shall be documented.
◍ Under the official definition of a "device", all of the following are
considered devices except:A) X-ray filmB) Sterilizers used for device
manufacturingC) Eyeglass lenses and framesD) In vitro diagnostic kit.
GUIDE 2026 FULL QUESTIONS AND
SOLUTIONS GRADED A+
◍ Under EU MDR, which document defines the methodology and scope for
generating clinical evidence throughout the device lifecycle?
A. Clinical Investigation Plan (CIP)
B. Summary of Safety and Clinical Performance (SSCP)
C. Clinical Evaluation Plan (CEP)
D. Postmarket Clinical Follow-Up (PMCF) Plan.
Answer: C. Clinical Evaluation Plan (CEP)
◍ Which of the following is NOT part of the General Safety and Performance
Requirements (GSPR) under IVDR?
A. Risk control measures
B. Labeling requirements
C. Economic feasibility
D. Performance evaluation.
Answer: C. Economic feasibility
◍ 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. None of the above.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 physical characteristics such as
, size, package, shape, color or composition should be considered to be one
device: Provided, The variation does not change the function or intended use
of the device.
◍ Under EU MDR, what is the typical frequency of notified body surveillance
audits for Class IIb devices?
A. Every 2 years
B. Once per product lifecycle
C. At least annually
D. Every 5 years.
Answer: C. At least annually
◍ An IVD submission could be submitted as a(n):
A. NDA
B. BLA
C. 510(k)
D. BLA or 510(k).
Answer: D. BLA or 510(k)IVDs can be submitted as a 510(k) under the
Food, Drug, and Cosmetic Act or a BLA under the Public Health Service
Act. Regulatory Reference: Public Health Service Act, Food, Drug, and
Cosmetic Act.
◍ According to the QSR, Design Outputs contain the following:A) Device
Master Record (DMR)B) The documentation from the last phase of the
complete Design Control processC) Test reports that support the Design
Inputs metD) All packaging and labeling associated with finished device E)
A and D above.
Answer: E) A and D aboveNOT RAC TEST STYLE QUESTION
◍ You are a German-based device manufacturer whose device is packaged in
Ireland and sold in the US through a US-based company. The 510(k) was
writtten by a contract organization. The label of our product may indicated
any of the following EXCEPT"
A. The principle place of business in the US
B. The packaging location address
, C. The address of the contractor who submitted the 510(k)
D. The address of the distributor.
Answer: C. The address of the contractor who submitted the
510(k)Regulatory Reference: FDCA 801(e)(i). Medical devices; name and
place of business of manufacturer, packer or distributor. (a) The label of a
device in package form shall specify conspicuously the name and place of
business of the manufacturer, packer or distributor.
◍ If your firm commercially distributes a Class III device subject to PMA
without an approved PMA, what is the statutory violation?A)
AdulterationB) Improper UseC) MisbrandingD) Idiocy.
Answer: A) Adulteration
◍ 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.
Answer: B. New Class II devices
◍ Design validation must:
A. Be performed using only simulations
B. Include testing under actual or simulated use conditions
C. Be conducted postmarket
D. Include supplier audits.
Answer: B. Include testing under actual or simulated use conditions
◍ Under EU MDR, which class of device typically requires clinical
investigation unless sufficient clinical evidence already exists?
A. Class I
B. Class IIa
C. Class IIb
D. Class III.
Answer: D. Class III
◍ Which mfgers must register their mfging facility with FDA?
, A. Component mfgers who sell only to device mfger using their components
B. Domestic (US) contract mfgers who do not directly distribute the final
product to the market
C. Domestic mfger of device being investigated under an IDE
D. Foreign mfgers shipping devices into US for sale in US.
Answer: D. Foreign mfgers shipping devices into the US for sale in the
USAll foreign mfgers making devices distributed in the US must register
with FDA.
◍ Which of the following is TRUE about the FDA's Global Unique Device
Identification Database (GUDID)?
A. It is private and accessible only to manufacturers
B. It stores both UDI-DI and UDI-PI data
C. It stores the static UDI-DI information for public access
D. It replaces the need for device listing with FDA.
Answer: C. It stores the static UDI-DI information for public access
◍ According to the Quality System Regulation, 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.
Answer: C. Maintenance must be performed at least annuallyQSR does not
specify "annually":Maintenance schedule. Each manufacturer shall establish
and maintain schedules for the adjustment, cleaning, and other maintenance
of equipment to ensure that manufacturing specifications are met.
maintenance activities, including the date and individual(s) performing the
maintenance activities, shall be documented.
◍ Under the official definition of a "device", all of the following are
considered devices except:A) X-ray filmB) Sterilizers used for device
manufacturingC) Eyeglass lenses and framesD) In vitro diagnostic kit.
