Device RAC Exam (New 2026/ 2027
Update) Questions & Answers 100%
Correct (Verified Solutions) - {Grade A}
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) - Correct answer 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 - Correct answer 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 - Correct answer 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 - Correct answer 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 - Correct answer D) Submission of
trial protocol to FDA for approval
FDA approval not needed for NSR (Non-Significant Risk device)
The establishment, performance and auditing of a human-use clinical device trial
requires conformance with all of the following except:
A) 21 CFR 50 Protection of Human Subjects
B) 21 CFR 56 IRB
C) 21 CFR 807 Establishment Registration
D) 21 CFR 812 IDE Exemptions - Correct answer C) 21 CFR 807 Establishment
Registration
Part 812 - Only covering setting up Clinical Trial - Requirements for what happens
during a trial will be covered later.
Update) Questions & Answers 100%
Correct (Verified Solutions) - {Grade A}
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) - Correct answer 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 - Correct answer 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 - Correct answer 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 - Correct answer 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 - Correct answer D) Submission of
trial protocol to FDA for approval
FDA approval not needed for NSR (Non-Significant Risk device)
The establishment, performance and auditing of a human-use clinical device trial
requires conformance with all of the following except:
A) 21 CFR 50 Protection of Human Subjects
B) 21 CFR 56 IRB
C) 21 CFR 807 Establishment Registration
D) 21 CFR 812 IDE Exemptions - Correct answer C) 21 CFR 807 Establishment
Registration
Part 812 - Only covering setting up Clinical Trial - Requirements for what happens
during a trial will be covered later.
