In vitro diagnostics: classification and approval basics (US) MCQs With Answer

Introduction:

In vitro diagnostics: classification and approval basics (US) MCQs With Answer is a focused quiz resource designed for M.Pharm students studying Regulatory Aspects of Medical Devices (MRA203T). This set explains how the U.S. Food and Drug Administration (FDA) classifies in vitro diagnostic (IVD) devices by risk, intended use, and technology, and outlines common regulatory pathways such as 510(k), De Novo, PMA, and Emergency Use Authorization (EUA). Questions emphasize analytical and clinical validation, laboratory regulations like CLIA, and post-market obligations. These thoughtfully constructed MCQs help students strengthen conceptual understanding and exam readiness by integrating regulatory principles with practical examples relevant to IVD development and approval.

Q1. What is the defining characteristic of an in vitro diagnostic (IVD) device according to FDA?

• A device intended for in vitro examination of specimens derived from the human body to provide information for diagnosis, prevention, or treatment
• A device implanted into the body to monitor physiological parameters
• A device used exclusively for veterinary testing
• A household test kit not intended for medical decision making

Correct Answer: A device intended for in vitro examination of specimens derived from the human body to provide information for diagnosis, prevention, or treatment

Q2. On what primary criteria does the FDA base its classification of IVD devices?

• Intended use and associated risk to patient and public health
• Manufacturing location and cost of the device
• Color of packaging and marketing budget
• Number of claims made on the label

Correct Answer: Intended use and associated risk to patient and public health

Q3. Which FDA device class generally requires Premarket Approval (PMA)?

• Class I
• Class II
• Class III
• Class IV

Correct Answer: Class III

Q4. Which regulatory pathway is typically used for a moderate-risk IVD that demonstrates substantial equivalence to a legally marketed device?

• 510(k) premarket notification
• Premarket Approval (PMA)
• Investigational Device Exemption (IDE)
• Biologics License Application (BLA)

Correct Answer: 510(k) premarket notification

Q5. Which pathway is appropriate for a novel, low-to-moderate risk IVD with no predicate device?

• De Novo classification request
• 510(k) submission referencing a predicate
• Premarket Approval (PMA)
• Investigational Device Exemption (IDE)

Correct Answer: De Novo classification request

Q6. What does EUA stand for and when is it used for IVDs?

• Emergency Use Authorization; during declared public health emergencies to allow use of tests before full approval
• Early Use Assessment; during early research stages
• Emergency Utility Approval; for consumer home tests only
• Extended Use Authorization; for devices past expiration

Correct Answer: Emergency Use Authorization; during declared public health emergencies to allow use of tests before full approval

Q7. Which submission type is commonly required for FDA clearance of a companion diagnostic?

• PMA submission as a companion diagnostic
• 510(k) notification referencing a predicate companion diagnostic
• De Novo for high-risk companion diagnostics
• CLIA certification only

Correct Answer: PMA submission as a companion diagnostic

Q8. How are Laboratory Developed Tests (LDTs) primarily regulated in the United States?

• Primarily regulated under CLIA by CMS; FDA has historically exercised enforcement discretion for many LDTs
• Fully regulated by FDA via PMA for all LDTs
• Regulated by the EPA for environmental testing standards
• Not subject to any regulatory oversight

Correct Answer: Primarily regulated under CLIA by CMS; FDA has historically exercised enforcement discretion for many LDTs

Q9. Which elements are core components of analytical validation for an IVD?

• Accuracy, precision, analytical sensitivity (LOD), analytical specificity and linearity
• Marketing claims, color of packaging, manufacturing cost
• Clinical utility and reimbursement codes only
• Only time-to-result and shelf life

Correct Answer: Accuracy, precision, analytical sensitivity (LOD), analytical specificity and linearity

Q10. What does clinical validation of an IVD demonstrate?

• Clinical sensitivity, clinical specificity and clinical utility for the intended use population
• Only the analytical limit of detection
• Manufacturing reproducibility across lots exclusively
• Label design preferences

Correct Answer: Clinical sensitivity, clinical specificity and clinical utility for the intended use population

Q11. Which regulatory controls are required in addition to general controls for Class II IVDs?

• Special controls such as performance standards, postmarket surveillance, and guidance documents
• No additional controls beyond general controls
• Only state-level approvals
• International standards exclusively

Correct Answer: Special controls such as performance standards, postmarket surveillance, and guidance documents

Q12. In a 510(k) submission, what is a ‘predicate device’?

• A legally marketed device used as a basis for demonstrating substantial equivalence
• A device currently under clinical investigation only
• An experimental device not cleared for marketing
• A competitor’s product intentionally excluded from comparisons

Correct Answer: A legally marketed device used as a basis for demonstrating substantial equivalence

Q13. Order the FDA device classes by increasing regulatory risk level.

• Class I < Class II < Class III
• Class III < Class II < Class I
• Class II < Class I < Class III
• Class I < Class III < Class II

Correct Answer: Class I < Class II < Class III

Q14. What does analytical specificity in IVD performance refer to?

• The ability of the assay to avoid cross-reactivity with non-target analytes
• The limit of detection for the target analyte
• The speed at which the assay returns a result
• The financial cost of running the test

Correct Answer: The ability of the assay to avoid cross-reactivity with non-target analytes

Q15. For a multiplex assay that detects several targets simultaneously, what does the FDA generally expect?

• Per-analyte analytical and clinical validation demonstrating performance for each target
• Validation of only one representative analyte and extrapolation to others
• No validation if overall accuracy is shown for any analyte
• Only batch-to-batch consistency data

Correct Answer: Per-analyte analytical and clinical validation demonstrating performance for each target

Q16. What information belongs in the intended use statement on an IVD label?

• Indications for use, specimen types, target population, and performance claims
• Only the manufacturer’s address and phone number
• Proprietary algorithm details and trade secrets
• Suggested retail price and distributor discounts

Correct Answer: Indications for use, specimen types, target population, and performance claims

Q17. What is the purpose of the FDA Breakthrough Devices Program for diagnostics?

• To expedite development and review of devices that provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions
• To provide free marketing support for consumer diagnostics
• To allow devices to bypass all regulatory review
• To regulate import tariffs on diagnostic devices

Correct Answer: To expedite development and review of devices that provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating conditions

Q18. Which quality regulation applies to manufacturers of IVD devices sold in the U.S.?

• Quality System Regulation (21 CFR Part 820)
• Good Laboratory Practice for Pharmaceuticals only
• Only ISO 9001 with no FDA requirements
• Federal Trade Commission (FTC) manufacturing rules

Correct Answer: Quality System Regulation (21 CFR Part 820)

Q19. What is the FDA reporting system for adverse events and certain device failures after marketing?

• Medical Device Reporting (MDR)
• ClinicalTrials.gov event log
• Manufacturer Annual Summary (MAS) only
• Product Information Bulletin (PIB)

Correct Answer: Medical Device Reporting (MDR)

Q20. How does CLIA categorize laboratory tests for regulatory oversight?

• Waived, moderate complexity, and high complexity
• Class I, Class II, and Class III
• Research, clinical, and commercial
• Analytical, clinical, and post-market

Correct Answer: Waived, moderate complexity, and high complexity

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