US regulatory pathways: 510(k), PMA, IDE and quality system (21 CFR Part 820) MCQs With Answer

Introduction: This quiz collection is designed for M.Pharm students studying Regulatory Aspects of Medical Devices (MRA203T) and focuses on US regulatory pathways: 510(k), PMA, IDE, and the Quality System Regulation (21 CFR Part 820). The set presents scenario-based and knowledge-check multiple-choice questions to deepen understanding of device classification, substantial equivalence, premarket submission types, investigational device study requirements, and essential quality system elements like design controls, CAPA, and recordkeeping. Answers are provided to reinforce learning and prepare students for exams and regulatory practice. Use these questions to test conceptual comprehension and to appreciate practical regulatory expectations for medical devices in the US market.

Q1. Which statement best describes the regulatory purpose of a 510(k) submission?

• To request approval for a novel high-risk device based solely on bench testing
• To demonstrate that a device is substantially equivalent to a legally marketed predicate device
• To obtain permission to start a clinical investigation of an unapproved device
• To register a manufacturing facility with FDA

Correct Answer: To demonstrate that a device is substantially equivalent to a legally marketed predicate device

Q2. Which device class is most likely to require a PMA rather than a 510(k)?

• Class I with general controls only
• Class II with a clear predicate device
• Class III intended to sustain or support life or present unreasonable risk
• Class II exempt from special controls

Correct Answer: Class III intended to sustain or support life or present unreasonable risk

Q3. What is the FDA review goal timeframe for a traditional 510(k) decision once a submission is accepted for review?

• 30 days
• 60 days
• 90 days
• 180 days

Correct Answer: 90 days

Q4. Which of the following is a distinctive element of a PMA application compared to a 510(k)?

• Requirement to compare with a predicate device
• Reliance primarily on bench testing only
• Extensive clinical data demonstrating safety and effectiveness
• No fees are charged for PMA submissions

Correct Answer: Extensive clinical data demonstrating safety and effectiveness

Q5. Under IDE regulations, what determines whether an investigational device study is classified as significant risk (SR) or non-significant risk (NSR)?

• The sponsor’s assessment alone
• The FDA directly assigns SR or NSR in all cases
• The IRB makes the final determination based on device risk and study procedures
• All implantable devices are automatically NSR

Correct Answer: The IRB makes the final determination based on device risk and study procedures

Q6. Which 510(k) variant is used when performance testing references recognized consensus standards and guidance documents to streamline review?

• Special 510(k)
• Abbreviated 510(k)
• De Novo request
• Emergency Use Authorization

Correct Answer: Abbreviated 510(k)

Q7. What action may a sponsor take if the FDA does not object to an IDE submission within the 30-day review period?

• Begin the investigational clinical study
• Assume the device is cleared for commercial marketing
• File a PMA without further data
• Terminate the study automatically

Correct Answer: Begin the investigational clinical study

Q8. Which element is NOT a required part of 21 CFR Part 820 design controls?

• Design and development planning
• Design inputs and outputs
• Design validation and verification
• Clinical trial informed consent form content

Correct Answer: Clinical trial informed consent form content

Q9. What is the main intent of the FDA’s De Novo classification process?

• To expedite approval of high-risk devices without data
• To classify novel low-to-moderate risk devices without a predicate and establish special controls
• To replace PMA for all Class III devices
• To provide emergency access to unapproved devices

Correct Answer: To classify novel low-to-moderate risk devices without a predicate and establish special controls

Q10. Under 21 CFR Part 820, what document contains instructions for manufacturing and specifications for the finished device?

• Design History File (DHF)
• Device Master Record (DMR)
• Device History Record (DHR)
• Quality System Record (QSR)

Correct Answer: Device Master Record (DMR)

Q11. Which type of 510(k) is intended for manufacturers making only certain types of device modifications where design control procedures and validated changes are documented?

• Traditional 510(k)
• Special 510(k)
• Abbreviated 510(k)
• PMA supplement

Correct Answer: Special 510(k)

Q12. Which of the following is a primary responsibility of a sponsor under an IDE?

• To determine marketing clearance for the device
• To ensure informed consent, IRB approval, monitoring, and safety reporting for the study
• To provide state-level licensing for investigators
• To publish study results in peer-reviewed journals

Correct Answer: To ensure informed consent, IRB approval, monitoring, and safety reporting for the study

Q13. Which 21 CFR Part 820 requirement specifically addresses corrective actions taken when nonconforming product or process issues are identified?

• Production and Process Controls
• Corrective and Preventive Action (CAPA)
• Management Responsibility
• Purchasing Controls

Correct Answer: Corrective and Preventive Action (CAPA)

Q14. What documentation demonstrates that a specific device was manufactured according to DMR and released for distribution?

• Design History File (DHF)
• Risk Management File
• Device History Record (DHR)
• Certificate of Free Sale

Correct Answer: Device History Record (DHR)

Q15. When seeking a PMA, which of the following procedures is commonly required by FDA as part of the evaluation process?

• No clinical data, only labeling review
• Panellist advisory committee review for certain devices
• Automatic approval if device was CE marked
• Only a 510(k) comparison to predicate device

Correct Answer: Panellist advisory committee review for certain devices

Q16. Which quality system requirement helps ensure purchased components and services meet specified requirements?

• Calibration controls
• Purchasing Controls
• Device Master Record
• Packaging and Labeling Controls

Correct Answer: Purchasing Controls

Q17. A manufacturer receives an FDA Form 483 after an inspection. What does this indicate?

• That the device is approved for marketing
• That the inspection revealed observations of potential regulatory nonconformance
• That the manufacturer has passed a compliance audit with no issues
• That FDA has issued a warning letter automatically

Correct Answer: That the inspection revealed observations of potential regulatory nonconformance

Q18. Under 21 CFR Part 820, what is the purpose of design validation?

• To ensure manufacturing equipment meets calibration specs
• To confirm the device conforms to design outputs only in bench tests
• To ensure the device conforms to user needs and intended use under actual or simulated use
• To document supplier qualifications

Correct Answer: To ensure the device conforms to user needs and intended use under actual or simulated use

Q19. Which submission would a sponsor use when requesting FDA permission to market a device intended to treat or diagnose a disease affecting fewer than 8,000 individuals per year in the US?

• Traditional 510(k)
• Humanitarian Device Exemption (HDE)
• Investigational Device Exemption (IDE)
• Abbreviated PMA

Correct Answer: Humanitarian Device Exemption (HDE)

Q20. Which action is required by 21 CFR Part 820 with respect to handling complaints about a device distributed to customers?

• Complaints must be archived without review
• Complaints must be reviewed and evaluated, and events meeting certain criteria must be investigated and documented
• Complaints can be ignored if fewer than five are received in a year
• Complaints should be redirected to the product’s distributor only

Correct Answer: Complaints must be reviewed and evaluated, and events meeting certain criteria must be investigated and documented

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