10 free, exam-style Regulatory Affairs Certification - Devices (RAC-DEVICES) practice questions with answers and explanations. No signup required. Work through them below, then take the full free RAC-DEVICES practice test to study every exam domain.
The RAC-DEVICES exam has 120 questions and runs 2 hours 30 minutes.
A regulatory professional is advising R&D on the lifecycle implications of using machine learning for image segmentation. Which framework BEST supports continuous algorithm updates without repeated submissions?
Correct answer: B - Predetermined Change Control Plan submission
A medical device firm is sequencing global market entry. The team wants minimum audit overhead across multiple jurisdictions. Which program BEST achieves this?
Correct answer: D - Medical Device Single Audit Program
MDSAP is the Medical Device Single Audit Program with five participating regulators: FDA (US), Health Canada, ANVISA (Brazil), TGA (Australia), and PMDA (Japan). A single MDSAP audit replaces routine audits across all five jurisdictions.
A device has the same intended use as a predicate but uses a different technological characteristic. The next 510(k) decision question is:
Correct answer: C - Whether differences raise new questions of S&E
FDA's Substantial Equivalence decision tree: Step 1 = same intended use? Step 2 = same technological characteristics? Step 3 = if different, do those differences raise new questions of safety/effectiveness? Step 4 = do performance data demonstrate.
A regulatory professional advises that a wearable continuously displays heart rate and provides exercise targets. The intended use is general wellness with no medical claims. Under §520(o), this product is:
Correct answer: A - Excluded from the FDA device definition
Effective February 2, 2026, combination product current Good Manufacturing Practice requirements reference which regulation as the device baseline?
Correct answer: C - 21 CFR 820 Quality Management System Regulation
Effective February 2, 2026, FDA's Quality Management System Regulation (QMSR) replaced the prior Quality System Regulation (QSR), incorporating ISO 13485:2016 by reference.
A manufacturer claims their device is the most accurate on the market without comparative clinical data. Under EU MDR, this MOST clearly violates which article?
Correct answer: A - Article 7 on misleading product claims
EU MDR Article 7 prohibits text, names, trademarks, pictures, and figurative or other signs that may mislead users or patients about the device's intended purpose, safety, and performance - explicitly including comparative claims unsupported by.
A connected SaMD device with cyber-device characteristics under §524B requires which premarket content?
Correct answer: D - Cybersecurity documentation including SBOM data
Under §524B and FDA's 2025 Cybersecurity Final Guidance, cyber device premarket submissions must include cybersecurity documentation - threat model, security risk management, security architecture views, Software Bill of Materials (SBOM) with.
A regulatory professional confirms an FDA 510(k) submission requires which user fee?
Correct answer: B - MDUFA V 510(k) standard or small-business fee
FDA medical device user fees are governed by MDUFA V (Medical Device User Fee Amendments, FY2023-FY2027). PDUFA covers prescription drugs, BsUFA covers biosimilars, and GDUFA covers generic drugs - none of these apply to 510(k) submissions.
A regulatory professional cross-checks the Risk Management File against the Clinical Evaluation Report. Inconsistency between them:
Correct answer: C - Could undermine the benefit-risk justification overall
ISO 14971 risk management and EU MDR Annex XIV clinical evaluation are intrinsically linked: residual risks identified in the Risk Management File must be addressed in the Clinical Evaluation Report's benefit-risk analysis, and clinical findings in.
An EU MDR Article 87 reporting timeline for death or serious deterioration is:
Correct answer: D - Without delay, but no later than 10 days from awareness
EU MDR Article 87(3) sets three vigilance reporting timelines that every RAC-Devices candidate must memorize: 2 days for serious public-health threats, 10 days for death or serious deterioration in health, and 15 days for any other serious incident.
The Regulatory Affairs Certification - Devices (RAC-DEVICES) exam is organized into 4 knowledge domains. These free practice questions are drawn from across them so you can see where you're strong and where to study:
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