DEVICE RAC EXAMS SCRIPT 2026 QUESTIONS
AND ANSWERS SURE A+
✔✔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 - ✔✔B. New Class II devices
✔✔Under IND/IDE regulations, obligations of a clinical study investigator do NOT
include:
A. Providing a final study report to the IRB
B. Protecting the rights, safety and welfare of study subjects
C. Controlling the test materials under investigation during the study
D. Keeping all unused test material at their facility until the drug/device is approved by
FDA - ✔✔D. Keeping all unused test material at their facility until the drug/device is
approved by FDA
✔✔All of the following are considered General Controls under the Food, Drug &
Cosmetic Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device - ✔✔B. Premarket approval application
Premarket approval application (PMA) is not a general control.
✔✔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 - ✔✔C. Maintenance must be
performed at least annually
QSR 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.
✔✔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 - ✔✔C. HIV diagnostic test kit
After the departure of therapeutic biological products to CDER, CBER was left with the
rest which essentially amounts to blood and related products, vaccines and gene
therapy, some devices and diagnostic test kits.
In the test question, I tried to distract you by putting blood into several of the responses
because when I hear blood, I think CBER. The key words are HIV (read blood related)
and diagnostic test kit
Thus, C is the best answer
A) Incorrect - regulated by CDRH
B) Incorrect - regulated by CDRH
C) Correct - in vitro diagnostic
D) Incorrect - regulated by CDRH
✔✔For a medical device, what is NOT a responsibility of the US Agent for a Foreign
Establishment?
A) Report adverse events under the MDR regulation
B) Assisting FDA in communications with foreign establishment
C) Responding to questions concerning the foreign establishment's products that are
imported or offered for import into the United States
D) Assisting FDA in scheduling inspections of the foreign establishment - ✔✔A) Report
adverse events under the MDR regulation
✔✔Which Congressional Act provided Statutory Authority to FDA to regulate medical
devices?
, A) Safe Medical Devices Act of 1990 (SMDA)
B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
C) Federal Food, Drug, Cosmetic Act (FDC Act)
D) Medical Device Amendments of 1976 (MDA) - ✔✔D) Medical Device Amendments of
1976 (MDA)
✔✔Which of the following is NOT a key medical device submission which directly leads
to marketing permission from FDA?
A) 510(k)
B) HDE
C) PMA
D) IDE - ✔✔D) IDE, Investigational Device Exemptions, Part 812
Your IDE is a permission to ship product for clinical trial use only. It is the mechanism to
have an EXEMPTION to meeting the pre-market notification or pre-market approval
requirements, in order to perform your clinical trials. IDE are a part of the process for
product registrations that require clinical trial data, but the IDE does not directly lead to
marketing permission.
✔✔At completion of 510(k) review, FDA may take the following actions except:
A) Declare device SE
B) Declare device not SE
C) State a 510(k) is not required to market the device
D) Approve the device for market - ✔✔D) Approve the device for market
510(k) is for clearance to market not an approval
✔✔From a pre-clinical viewpoint, which of the following constitute pre-clinical activities
in medical device development?
A) Animal use testing to validate the design of your device
B) Bench testing to verify that your design performs as designed
C) Biocompatibility/Toxicity testing
D) Functional/Safety/Performance testing
E) All of the above - ✔✔E) All of the above
NOT a RAC test style question
Pre-clinical refers to any testing NOT performed in a human being.
✔✔With respect to a Non-Significant Risk device clinical trial, which is NOT required
before starting the trial?
AND ANSWERS SURE A+
✔✔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 - ✔✔B. New Class II devices
✔✔Under IND/IDE regulations, obligations of a clinical study investigator do NOT
include:
A. Providing a final study report to the IRB
B. Protecting the rights, safety and welfare of study subjects
C. Controlling the test materials under investigation during the study
D. Keeping all unused test material at their facility until the drug/device is approved by
FDA - ✔✔D. Keeping all unused test material at their facility until the drug/device is
approved by FDA
✔✔All of the following are considered General Controls under the Food, Drug &
Cosmetic Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device - ✔✔B. Premarket approval application
Premarket approval application (PMA) is not a general control.
✔✔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 - ✔✔C. Maintenance must be
performed at least annually
QSR 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.
✔✔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 - ✔✔C. HIV diagnostic test kit
After the departure of therapeutic biological products to CDER, CBER was left with the
rest which essentially amounts to blood and related products, vaccines and gene
therapy, some devices and diagnostic test kits.
In the test question, I tried to distract you by putting blood into several of the responses
because when I hear blood, I think CBER. The key words are HIV (read blood related)
and diagnostic test kit
Thus, C is the best answer
A) Incorrect - regulated by CDRH
B) Incorrect - regulated by CDRH
C) Correct - in vitro diagnostic
D) Incorrect - regulated by CDRH
✔✔For a medical device, what is NOT a responsibility of the US Agent for a Foreign
Establishment?
A) Report adverse events under the MDR regulation
B) Assisting FDA in communications with foreign establishment
C) Responding to questions concerning the foreign establishment's products that are
imported or offered for import into the United States
D) Assisting FDA in scheduling inspections of the foreign establishment - ✔✔A) Report
adverse events under the MDR regulation
✔✔Which Congressional Act provided Statutory Authority to FDA to regulate medical
devices?
, A) Safe Medical Devices Act of 1990 (SMDA)
B) Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
C) Federal Food, Drug, Cosmetic Act (FDC Act)
D) Medical Device Amendments of 1976 (MDA) - ✔✔D) Medical Device Amendments of
1976 (MDA)
✔✔Which of the following is NOT a key medical device submission which directly leads
to marketing permission from FDA?
A) 510(k)
B) HDE
C) PMA
D) IDE - ✔✔D) IDE, Investigational Device Exemptions, Part 812
Your IDE is a permission to ship product for clinical trial use only. It is the mechanism to
have an EXEMPTION to meeting the pre-market notification or pre-market approval
requirements, in order to perform your clinical trials. IDE are a part of the process for
product registrations that require clinical trial data, but the IDE does not directly lead to
marketing permission.
✔✔At completion of 510(k) review, FDA may take the following actions except:
A) Declare device SE
B) Declare device not SE
C) State a 510(k) is not required to market the device
D) Approve the device for market - ✔✔D) Approve the device for market
510(k) is for clearance to market not an approval
✔✔From a pre-clinical viewpoint, which of the following constitute pre-clinical activities
in medical device development?
A) Animal use testing to validate the design of your device
B) Bench testing to verify that your design performs as designed
C) Biocompatibility/Toxicity testing
D) Functional/Safety/Performance testing
E) All of the above - ✔✔E) All of the above
NOT a RAC test style question
Pre-clinical refers to any testing NOT performed in a human being.
✔✔With respect to a Non-Significant Risk device clinical trial, which is NOT required
before starting the trial?
