DEVICE RAC ACTUAL 2025/2026 EXAM QUESTIONS | WELL DETAILED & VERIFIED
SOLUTIONS
Which division has primary jurisdiction over a vascular graft with an antibiotic based on
primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
C. CDRH
In this combination of a device and a drug, the primary mode of action is that of the
vascular graft (device). The antibiotic is supportive in this case.
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)
A. Special 510(k)
,A Special 510(k) is allowed if a modification to the legally marketed device is being made
that relies on compliance with design controls, including design validation. The incentive
provided for manufacturers to choose this option is that 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 Approaches to Demonstrating Substantial Equivalence in
Premarket Notifications.
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?
A) Informed consent of trial participants
B) IRB approval of the trial
C) Financial disclosure by investigators
D) Submission of trial protocol to FDA for approval
D) Submission of trial protocol to FDA for approval
FDA approval not needed for NSR (Non-Significant Risk device)
SOLUTIONS
Which division has primary jurisdiction over a vascular graft with an antibiotic based on
primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP
C. CDRH
In this combination of a device and a drug, the primary mode of action is that of the
vascular graft (device). The antibiotic is supportive in this case.
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)
A. Special 510(k)
,A Special 510(k) is allowed if a modification to the legally marketed device is being made
that relies on compliance with design controls, including design validation. The incentive
provided for manufacturers to choose this option is that 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 Approaches to Demonstrating Substantial Equivalence in
Premarket Notifications.
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?
A) Informed consent of trial participants
B) IRB approval of the trial
C) Financial disclosure by investigators
D) Submission of trial protocol to FDA for approval
D) Submission of trial protocol to FDA for approval
FDA approval not needed for NSR (Non-Significant Risk device)
