RAC Medical Devices Test Study Guide 2025/2026 Accurate
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Section 1: Regulatory Strategy and Premarket Submissions (Questions 1-25)
1. What is the primary regulatory classification criterion for a medical device in the United
States?
• A. The cost of the device
• B. The intended use and indications for use
• C. The technological characteristics of the device
• D. The year it was first invented
• Answer: B. The intended use and indications for use.
• Rationale: While technological characteristics (C) inform the risk, the intended use is the
foundation for classification. It determines the regulatory controls necessary to provide
reasonable assurance of safety and effectiveness. The FDA's classification rules are based
on what the device is intended to diagnose, treat, prevent, cure, or mitigate.
2. A new device intended to sustain life is classified as Class III. What is the most common
premarket submission pathway for such a device?
• A. 510(k)
• B. Pre-Submission
• C. De Novo Request
• D. Premarket Approval (PMA)
• Answer: D. Premarket Approval (PMA).
• Rationale: Class III devices are those that support or sustain human life, are of
substantial importance in preventing impairment of human health, or present a
potential unreasonable risk of illness or injury. The PMA pathway requires the
manufacturer to provide valid scientific evidence (typically from clinical trials) to
demonstrate the device's safety and effectiveness.
, 3. The Least Burdensome Principle is a key concept in FDA reviews. What does it mean?
• A. The manufacturer should spend the least amount of money.
• B. The FDA should request only the information necessary to determine device safety
and effectiveness.
• C. The device should be the simplest design possible.
• D. The review timeline should be the shortest possible.
• Answer: B. The FDA should request only the information necessary to determine device
safety and effectiveness.
• Rationale: The Least Burdensome Principle is intended to streamline the regulatory
process. It guides FDA staff to focus their requests for information on the most critical
questions, avoiding unnecessary data collection that does not contribute to the
regulatory decision.
4. What is the primary purpose of a Pre-Submission?
• A. To submit a full marketing application
• B. To obtain formal agreement from the FDA on proposed testing methods or clinical
trial design before investing significant resources
• C. To report a device malfunction
• D. To register an establishment
• Answer: B. To obtain formal agreement from the FDA on proposed testing methods or
clinical trial design.
• Rationale: A Pre-Submission (Pre-Sub) is a formal, written mechanism for sponsors to
receive FDA feedback on specific questions related to a future marketing submission. It
is a strategic tool to de-risk development and avoid potential Refuse-to-File or major
deficiency letters later.
5. A Safer Technologies Program (STeP) is designed for which type of devices?
• A. All Class I devices
• B. Breakthrough Devices that are subject to a PMA
• C. Eligible devices that make safety-focused modifications to a predicate
• D. Software as a Medical Device (SaMD)
Questions and Verified Correct Solutions with Rationales ||
100% Guaranteed Pass <Latest Version>
Section 1: Regulatory Strategy and Premarket Submissions (Questions 1-25)
1. What is the primary regulatory classification criterion for a medical device in the United
States?
• A. The cost of the device
• B. The intended use and indications for use
• C. The technological characteristics of the device
• D. The year it was first invented
• Answer: B. The intended use and indications for use.
• Rationale: While technological characteristics (C) inform the risk, the intended use is the
foundation for classification. It determines the regulatory controls necessary to provide
reasonable assurance of safety and effectiveness. The FDA's classification rules are based
on what the device is intended to diagnose, treat, prevent, cure, or mitigate.
2. A new device intended to sustain life is classified as Class III. What is the most common
premarket submission pathway for such a device?
• A. 510(k)
• B. Pre-Submission
• C. De Novo Request
• D. Premarket Approval (PMA)
• Answer: D. Premarket Approval (PMA).
• Rationale: Class III devices are those that support or sustain human life, are of
substantial importance in preventing impairment of human health, or present a
potential unreasonable risk of illness or injury. The PMA pathway requires the
manufacturer to provide valid scientific evidence (typically from clinical trials) to
demonstrate the device's safety and effectiveness.
, 3. The Least Burdensome Principle is a key concept in FDA reviews. What does it mean?
• A. The manufacturer should spend the least amount of money.
• B. The FDA should request only the information necessary to determine device safety
and effectiveness.
• C. The device should be the simplest design possible.
• D. The review timeline should be the shortest possible.
• Answer: B. The FDA should request only the information necessary to determine device
safety and effectiveness.
• Rationale: The Least Burdensome Principle is intended to streamline the regulatory
process. It guides FDA staff to focus their requests for information on the most critical
questions, avoiding unnecessary data collection that does not contribute to the
regulatory decision.
4. What is the primary purpose of a Pre-Submission?
• A. To submit a full marketing application
• B. To obtain formal agreement from the FDA on proposed testing methods or clinical
trial design before investing significant resources
• C. To report a device malfunction
• D. To register an establishment
• Answer: B. To obtain formal agreement from the FDA on proposed testing methods or
clinical trial design.
• Rationale: A Pre-Submission (Pre-Sub) is a formal, written mechanism for sponsors to
receive FDA feedback on specific questions related to a future marketing submission. It
is a strategic tool to de-risk development and avoid potential Refuse-to-File or major
deficiency letters later.
5. A Safer Technologies Program (STeP) is designed for which type of devices?
• A. All Class I devices
• B. Breakthrough Devices that are subject to a PMA
• C. Eligible devices that make safety-focused modifications to a predicate
• D. Software as a Medical Device (SaMD)
