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Free RAC-DEVICES Practice Questions

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.

Question 1

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?

  1. Special 510(k) program for software changes
  2. Predetermined Change Control Plan submission
  3. Real-Time PMA Supplement for AI algorithm updates
  4. Letter to File for non-significant software changes
Show answer & explanation

Correct answer: B - Predetermined Change Control Plan submission

Question 2

A medical device firm is sequencing global market entry. The team wants minimum audit overhead across multiple jurisdictions. Which program BEST achieves this?

  1. FDA Quality System Inspection Technique
  2. ISO 13485 third-party certification
  3. WHO Prequalification audit pathway
  4. Medical Device Single Audit Program
Show answer & explanation

Correct answer: D - Medical Device Single Audit Program

Question 3

A device has the same intended use as a predicate but uses a different technological characteristic. The next 510(k) decision question is:

  1. Whether the device qualifies for De Novo pathway
  2. Whether the predicate is still legally marketed
  3. Whether differences raise new questions of S&E
  4. Whether the device requires a PMA pathway
Show answer & explanation

Correct answer: C - Whether differences raise new questions of S&E

Question 4

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:

  1. Excluded from the FDA device definition
  2. A Class II device requiring 510(k) clearance
  3. Subject to PMA approval as a Class III device
  4. Required to obtain De Novo classification
Show answer & explanation

Correct answer: A - Excluded from the FDA device definition

Question 5

Effective February 2, 2026, combination product current Good Manufacturing Practice requirements reference which regulation as the device baseline?

  1. 21 CFR 820 Quality System Regulation framework
  2. 21 CFR 211 drug cGMP framework reference
  3. 21 CFR 820 Quality Management System Regulation
  4. 21 CFR 600 biologics standards framework
Show answer & explanation

Correct answer: C - 21 CFR 820 Quality Management System Regulation

Question 6

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?

  1. Article 7 on misleading product claims
  2. Article 14 on distributor obligations
  3. Article 10 on manufacturer obligations
  4. Article 5 on placing on the market
Show answer & explanation

Correct answer: A - Article 7 on misleading product claims

Question 7

A connected SaMD device with cyber-device characteristics under §524B requires which premarket content?

  1. Penetration test reports from a federal agency
  2. An external NIST cybersecurity certification mark
  3. Encryption keys disclosed to FDA reviewer staff
  4. Cybersecurity documentation including SBOM data
Show answer & explanation

Correct answer: D - Cybersecurity documentation including SBOM data

Question 8

A regulatory professional confirms an FDA 510(k) submission requires which user fee?

  1. PDUFA fee under drug user fee schedule
  2. MDUFA V 510(k) standard or small-business fee
  3. BsUFA fee under biosimilar user fee schedule
  4. GDUFA fee under generic drug user fee schedule
Show answer & explanation

Correct answer: B - MDUFA V 510(k) standard or small-business fee

Question 9

A regulatory professional cross-checks the Risk Management File against the Clinical Evaluation Report. Inconsistency between them:

  1. Has no impact on regulatory submission review process
  2. Triggers automatic De Novo classification request
  3. Could undermine the benefit-risk justification overall
  4. Only affects post-market surveillance plans drafted
Show answer & explanation

Correct answer: C - Could undermine the benefit-risk justification overall

Question 10

An EU MDR Article 87 reporting timeline for death or serious deterioration is:

  1. Without delay, but no later than 2 days from awareness
  2. Without delay, but no later than 7 days from awareness
  3. Without delay, but no later than 15 days from awareness
  4. Without delay, but no later than 10 days from awareness
Show answer & explanation

Correct answer: D - Without delay, but no later than 10 days from awareness

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