20 Free RAC (Devices) Sample Questions — With Full Explanations and Official Sources 

If you're preparing for the RAC (Devices) exam, the fastest way to find out where you actually stand isn't another generic quiz — it's working through questions built the way the real exam is built: scenario-driven, spanning the full device lifecycle, and mapped to the current four-domain blueprint.

Below are 20 original RAC Devices practice questions — five per domain, weighted the same way the real exam is — covering Strategic Planning, Design and Development, Process for Licensing/Registration/Renewals, and Post-Market Activities. Every question includes a full explanation, and — because guessing why an answer is correct isn't the same as verifying it — a References & Further Reading section linking to the actual FDA guidance, CFR section, ISO standard, or EU MDR article the answer is based on.

Work through the questions first without looking at the explanations, then check your reasoning against each one and follow the source links to go deeper on anything that felt shaky.

Jump to a domain: Domain I: Strategic Planning · Domain II: Design and Development · Domain III: Licensing, Registration & Renewals · Domain IV: Post-Market Activities · FAQs

Domain I: Strategic Planning

1. Selecting a predicate device for a 510(k) submission

When selecting a predicate device for a 510(k) submission, which factor carries the most weight in supporting substantial equivalence?

A. The predicate's manufacturer has a strong market reputation B. The predicate shares the same intended use and similar technological characteristics C. The predicate is the newest device cleared in that product category D. The predicate is manufactured in the same country as the new device

Correct Answer: B. Substantial equivalence hinges on intended use and technological characteristics — not brand reputation, recency, or manufacturing location, none of which are regulatory criteria under the 510(k) framework. Under Section 513(i) of the FD&C Act, a device is substantially equivalent if it has the same intended use as the predicate and either the same technological characteristics, or different characteristics that don't raise new questions of safety and effectiveness.

References & Further Reading

• FDA — The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications

• Cornell LII — 21 CFR Part 807 (Establishment Registration and Device Listing / Premarket Notification)

2. Getting informal FDA feedback before a submission

A company wants informal, non-binding feedback from FDA on its proposed regulatory strategy before finalizing a submission. Which mechanism is designed for this?

A. A 510(k) resubmission B. A Pre-Submission (Q-Submission) meeting C. An Investigational Device Exemption (IDE) application D. A Post-Approval Study report

Correct Answer: B. The Q-Submission (Pre-Sub) process exists specifically so sponsors can get FDA feedback on strategy, testing plans, or classification questions before committing to a formal submission pathway. Pre-Subs are voluntary, carry no user fee, and can be requested ahead of a 510(k), De Novo, PMA, or IDE.

References & Further Reading

• FDA — Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (final guidance)

• FDA CDRH — Q-Submission Program overview

3. Jurisdiction for a drug-device combination product

A device combines a drug-eluting stent with a therapeutic drug coating. Determining lead regulatory jurisdiction (device center vs. drug center) is based primarily on:

A. Which component is more expensive to manufacture B. The device's primary mode of action C. Which regulatory pathway is faster D. The sponsor's preference

Correct Answer: B. Combination products are assigned a lead review center based on primary mode of action (PMOA) — the single mode of action expected to make the greatest contribution to the product's overall therapeutic effect — not cost, speed, or sponsor preference. If the PMOA can't be determined, FDA's Office of Combination Products (OCP) applies a defined algorithm under 21 CFR Part 3.

References & Further Reading

• FDA — Frequently Asked Questions About Combination Products (Office of Combination Products)

• Cornell LII — 21 CFR Part 3 — Product Jurisdiction

4. Strategic planning for a pediatric-use device

A sponsor is developing a device intended specifically for pediatric use. Which regulatory consideration is unique to this strategic planning stage?

A. Pediatric devices are automatically exempt from premarket review B. Sizing, growth, and age-appropriate testing requirements must be factored into the regulatory strategy C. Pediatric devices skip labeling requirements D. No special considerations apply beyond standard adult-device requirements

Correct Answer: B. Devices for special populations like pediatric patients carry additional considerations — device sizing across growth stages, age-appropriate clinical or bench testing, and use-environment factors — that need to be built into strategy from the start, not addressed as an afterthought. FDA reviews pediatric devices through the same premarket pathways (510(k), PMA, HDE) but with pediatric-specific study and labeling expectations layered on top.

References & Further Reading

• FDA — Premarket Assessment of Pediatric Medical Devices — Guidance for Industry and FDA Staff

• FDA — Providing Information about Pediatric Uses of Medical Devices

5. Building a global commercialization strategy

When building a global commercialization strategy for a single device, the most important early strategic task is:

A. Filing simultaneously in every target market regardless of differences B. Identifying where regulatory requirements and classification diverge across target markets C. Choosing the market with the lowest registration fee first D. Waiting until after U.S. clearance to consider any other market

Correct Answer: B. Regulatory requirements, classification rules, and evidence expectations vary by market — a sound global strategy identifies those divergences early so the development and evidence-generation plan can support multiple markets efficiently, rather than sequentially recreating work. This is why regulatory strategists map device classification and evidence requirements across target geographies (US FDA, EU MDR, and other national frameworks) before finalizing a single test plan.

References & Further Reading

• IMDRF — Medical Device Regulatory Requirements by Jurisdiction

• FDA — Comparison of Global Medical Device Regulatory Frameworks (International Programs)

Domain II: Design and Development

6. Design verification vs. design validation

What is the key distinction between design verification and design validation?

A. Verification confirms the device meets user needs; validation confirms it meets design inputs B. Verification confirms the device meets design inputs/specifications; validation confirms it meets user needs and intended use C. Verification and validation are interchangeable terms for the same activity D. Verification applies only to software; validation applies only to hardware

Correct Answer: B. Verification asks "did we build the device right" (does it meet its specified design inputs), while validation asks "did we build the right device" (does it meet user needs and intended use) — a foundational design controls distinction under 21 CFR 820.30. Design validation must be performed on production units or equivalents under actual or simulated use conditions and must include software validation and risk analysis where appropriate.

References & Further Reading

• Cornell LII — 21 CFR § 820.30 — Design controls

• FDA — Design Controls presentation, Office of Regulatory Affairs

7. A new hazard identified during design review

During design review, a risk analysis reveals a new hazard not previously identified. What is the appropriate next step?

A. Ignore it if the device has already passed bench testing B. Update the risk management file and evaluate whether additional risk controls or testing are needed C. Proceed to submission and address it only if a regulator raises a question D. Document it informally without updating any formal risk documentation

Correct Answer: B. ISO 14971 requires risk management to be a living process throughout design and development — a newly identified hazard must be documented in the risk management file and evaluated for whether existing controls are sufficient or new ones are needed. Risk management under ISO 14971 doesn't end at initial design freeze; it continues through verification, validation, and into the post-market phase.

References & Further Reading

• ISO — ISO 14971:2019, Medical devices — Application of risk management to medical devices

• MedicalDeviceHQ — Illustrated guide to risk management for medical devices and ISO 14971 (plain-language overview by an ISO 14971:2019 technical committee member — use alongside, not instead of, the standard itself)

8. A mid-development change to sterilization method

A design change made mid-development alters the device's sterilization method. From a regulatory standpoint, this change should be:

A. Ignored, since sterilization method isn't a regulated attribute B. Evaluated for its impact on the device's regulatory status, including whether it affects a prior predicate comparison or requires new testing C. Automatically disqualifying for any future submission D. Addressed only in post-market labeling

Correct Answer: B. Design or manufacturing changes made during development — including sterilization method — can affect substantial equivalence arguments, risk profile, or required testing, so their regulatory impact must be actively evaluated, not assumed away or deferred. Under 21 CFR 820.30(i), design changes must be identified, documented, and verified or validated (as appropriate) and reviewed and approved before implementation.

References & Further Reading

• Cornell LII — 21 CFR § 820.30(i) — Design changes

• FDA — Recognized Consensus Standards for sterilization (ISO 11135, ISO 11137, etc.)

9. Objective evidence supporting a product claim

Which of the following best demonstrates that testing results support a proposed product claim?

A. The claim is included in early marketing materials B. Objective test data directly maps to and supports the specific claim being made C. A competitor makes a similar claim D. The engineering team believes the claim is reasonable

Correct Answer: B. Regulatory support for a claim requires objective evidence — test data specifically designed to demonstrate the claim — not market precedent, internal belief, or promotional intent. This principle underlies both premarket substantial-equivalence/safety-and-effectiveness arguments and post-market labeling and advertising compliance.

References & Further Reading

• FDA — Labeling and Promotion, Medical Devices (Device Advice)

• FDA — The 510(k) Program: Evaluating Substantial Equivalence

10. What design controls exist to ensure

Under a compliant quality management system, design control requirements exist to ensure:

A. Devices are developed faster than competitors B. Specified design requirements are established and met throughout development, verification, and validation C. Marketing materials are approved before engineering begins D. Only the final device undergoes any quality review

Correct Answer: B. Design controls (21 CFR 820.30, and equivalently under ISO 13485) exist to ensure a structured, documented process where design inputs are defined, outputs are verified against them, and the finished design is validated against user needs — not to accelerate speed to market or shortcut review to a single final check.

References & Further Reading

• Cornell LII — 21 CFR § 820.30 — Design controls (full text)

• ISO — ISO 13485:2016, Medical devices — Quality management systems

Domain III: Process for Licensing, Registration, and Renewals

11. The document uniquely required for a PMA

A device requires Premarket Approval (PMA) rather than a 510(k). Which document is uniquely required to support the design's development history?

A. A Certificate of Free Sale B. A Design History File (DHF) C. An Annual Report D. A Certificate to Foreign Government

Correct Answer: B. The Design History File documents the design and development process and is a required element supporting a PMA submission, demonstrating the finished device matches its approved design plan. The DHF requirement itself comes from the design controls regulation (21 CFR 820.30(j)), and it's one of the records FDA reviews as part of a complete PMA file (21 CFR Part 814).

References & Further Reading

• Cornell LII — 21 CFR § 820.30(j) — Design history file

• FDA — PMA (Premarket Approval) — Device Advice

12. Responding to an FDA Additional Information (AI) request

After submitting a 510(k), FDA issues an Additional Information (AI) request identifying deficiencies. The appropriate response is to:

A. Withdraw the submission and resubmit as a new application B. Directly address each identified deficiency with supporting data or clarification within the response timeframe C. Ignore minor deficiencies and only address major ones D. Request that FDA waive the deficiencies

Correct Answer: B. A timely, complete response addressing every identified deficiency is the standard and most efficient path forward — partial responses or ignoring items typically extend review time rather than shortening it, and an incomplete AI response risks the submission being placed on hold or ultimately deemed "not substantially equivalent."

References & Further Reading

• FDA — 510(k) Submission Process (Device Advice)

• FDA — Refuse to Accept Policy for 510(k)s

13. Ongoing conformity documentation under EU MDR

Under EU MDR, which document set is central to demonstrating a device's ongoing conformity and must be maintained and updated throughout the device's life?

A. The Certificate of Free Sale only B. The technical documentation, including the Clinical Evaluation Report C. A one-time submission with no update requirement D. Only the CE marking certificate itself

Correct Answer: B. EU MDR technical documentation — including the Clinical Evaluation Report — is not a one-time filing; it must be actively maintained and updated to reflect ongoing clinical evidence, changes, and post-market data throughout the device's life. This obligation flows from Article 61 (clinical evaluation) together with Annex II/Annex XIV, which require the CER to be updated with data from post-market surveillance and post-market clinical follow-up (PMCF).

References & Further Reading

• EUR-Lex — Regulation (EU) 2017/745, Article 61 — Clinical evaluation

• EUR-Lex — Regulation (EU) 2017/745, Annex II — Technical documentation

14. Proof of legal marketing for export

A manufacturer needs to export a device to a market that requires proof the device is legally marketed in the manufacturer's home country. Which document typically satisfies this?

A. A Design History File B. A Certificate to Foreign Government (or equivalent Certificate of Free Sale) C. A 510(k) clearance letter alone, with no additional certificate D. An internal quality manual

Correct Answer: B. Many importing countries require a Certificate to Foreign Government (CFG) — historically also called a Certificate of Free Sale — as part of customs/export documentation, confirming the device is legally marketed in its country of origin. To qualify, the U.S. establishment must be FDA-registered, the device must be listed, and it must be manufactured under the Quality System/QMSR requirements of 21 CFR Part 820.

References & Further Reading

• FDA — Types of Export Certificates (CDRH)

• FDA — Exporting Medical Devices — Device Advice overview

15. A change significantly affecting safety or effectiveness

A cleared device undergoes a change that FDA would classify as significantly affecting safety or effectiveness. The manufacturer should:

A. Continue marketing without further action, since the device was already cleared once B. Submit a new 510(k) or appropriate update reflecting the change before marketing the modified device C. Wait for the next periodic report to disclose the change D. Notify only its distributors, not FDA

Correct Answer: B. A change significantly affecting safety or effectiveness generally requires a new submission (such as a new 510(k)) before the modified device can be marketed — critical changes cannot simply be disclosed after the fact through routine reporting. This requirement comes directly from 21 CFR 807.81(a)(3), and FDA's "Deciding When to Submit a 510(k)" guidance walks through how to evaluate specific categories of change.

References & Further Reading

• Cornell LII — 21 CFR § 807.81 — When a premarket notification submission is required

• FDA — Deciding When to Submit a 510(k) for a Change to an Existing Device

Domain IV: Post-Market Activities

16. Timeline for reporting a serious injury under U.S. MDR

A manufacturer receives a complaint suggesting a device malfunction may have contributed to a serious injury, and this event type isn't already described in labeling. Under U.S. Medical Device Reporting requirements, this generally must be reported to FDA within:

A. 5 calendar days B. 30 calendar days C. 90 calendar days D. Only at the next annual report

Correct Answer: B. Under 21 CFR 803.50(a), manufacturers must generally report a serious injury (and related malfunctions) within 30 calendar days of becoming aware of the event. A shorter 5-working-day timeline applies separately when the event requires remedial action to prevent an unreasonable risk of substantial public health harm, or when FDA specifically requests it.

References & Further Reading

• Cornell LII — 21 CFR § 803.50 — Manufacturer reporting requirements

• FDA — Medical Device Reporting (MDR): How to Report Medical Device Problems

17. What a Field Safety Corrective Action (FSCA) is

A Field Safety Corrective Action (FSCA) is best described as:

A. A routine software update unrelated to safety B. An action taken by a manufacturer to reduce a risk of death or serious injury associated with a device already on the market C. A marketing campaign following a product recall D. An internal-only quality review with no external notification

Correct Answer: B. An FSCA is a corrective action — which can include a recall, field correction, or advisory notice — taken specifically to address a safety risk with a device already in the field, often requiring notification to regulators and/or affected users. The definition comes from Article 2(68) of the EU MDR, and reportable FSCAs are communicated to users via a Field Safety Notice (FSN).

References & Further Reading

• EUR-Lex — Regulation (EU) 2017/745, Article 2(68) — Definitions

• European Commission — MDCG 2023-3, Guidance on vigilance terms and concepts

18. The EU MDR Post-Market Surveillance Plan

Under EU MDR, a manufacturer's Post-Market Surveillance (PMS) Plan is best described as:

A. An optional document only high-risk device manufacturers need B. A proactive, systematic process for collecting and evaluating real-world data on a marketed device throughout its lifecycle C. A one-time report filed only if a serious incident occurs D. A document required only at the time of initial CE marking, with no ongoing obligation

Correct Answer: B. EU MDR requires an active, ongoing PMS process — not a passive or one-time document — to systematically gather and evaluate real-world performance and safety data throughout the device's lifecycle, feeding into documents like the PSUR and updated Clinical Evaluation Report. This obligation applies to manufacturers of every device class, proportionate to risk, under Article 83, with the plan itself required by Article 84 and its content specified in Annex III.

References & Further Reading

• EUR-Lex — Regulation (EU) 2017/745, Article 83 — Post-market surveillance system of the manufacturer

• EUR-Lex — Regulation (EU) 2017/745, Annex III — Technical documentation on post-market surveillance

19. A new promotional claim added to marketed labeling

A marketed device's labeling is being updated to include a new promotional claim. From a regulatory standpoint, this change should be:

A. Treated as purely a marketing decision requiring no regulatory review B. Assessed for its regulatory impact, since labeling and promotional claims must be supported by evidence and may affect the device's compliance status C. Automatically approved if legal has signed off D. Irrelevant unless the claim mentions a new indication

Correct Answer: B. Labeling and promotional material changes — including new claims — require regulatory assessment to confirm they're supported by evidence and don't inadvertently expand the device's claimed intended use beyond what's been cleared or approved. An unsupported or scope-expanding claim can trigger both labeling violations and a new-submission requirement.

References & Further Reading

• FDA — Advertising and Promotional Labeling for Medical Devices (Device Advice)

• Cornell LII — 21 CFR § 807.81 — When a new submission is required

20. Trending complaints in post-market quality management

A manufacturer notices a trend of similar complaints about a specific device component. The appropriate next step in post-market quality management is to:

A. Close each complaint individually with no broader review, since each is a separate incident B. Evaluate the trend through the CAPA (Corrective and Preventive Action) process to determine root cause and whether broader action is needed C. Wait until a regulator identifies the trend independently D. Update marketing materials to de-emphasize the affected component

Correct Answer: B. Trending complaints is a core post-market surveillance function — a pattern across individually-closed complaints can indicate a systemic issue that only a CAPA-level root cause investigation will catch and appropriately address. This obligation is set out in 21 CFR 820.100, which requires manufacturers to establish and maintain CAPA procedures and to verify or validate that any corrective/preventive action taken is actually effective.

References & Further Reading

• Cornell LII — 21 CFR § 820.100 — Corrective and preventive action

• FDA — Complaint Files and CAPA, Quality System Regulation overview

Frequently Asked Questions About the RAC Devices Exam

What are the four domains of the RAC (Devices) exam? Strategic Planning, Design and Development, Process for Licensing/Registration/Renewals, and Post-Market Activities — the same four domains used to structure the practice questions above.

How many practice questions should I complete before sitting the RAC Devices exam? Twenty questions is enough to get a feel for the exam's style, but not enough to reliably diagnose your domain-by-domain readiness. That takes hundreds of scenario-based questions across a realistic mix, plus full-length timed mocks that mirror the real exam's pace.

Is the RAC Devices exam scenario-based or purely definitional? It's scenario-driven. Rather than asking you to define a term in isolation, it places you in a device-lifecycle situation — a design change, a complaint trend, a jurisdiction question — and asks what the appropriate next step is, which is why the practice questions above are written the same way.

Want to See Where You Actually Stand?

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