RAC Practice Test
Updated October 2026Facts verified Oct 20, 2026 against RAPS
Did you know? The RAC Exam is updated regularly to reflect changes in global regulations. Our RAC Exam Prep materials are current for the cycle, covering the latest US FDA and EU MDR/IVDR requirements. Practice with the free Regulatory Affairs Certification practice test on PracticeTestGeeks (7 questions with answer explanations).
RAC: upcoming dates and official changes
- Nov 2, 2026 – Dec 4, 2026: The Autumn 2026 RAC exam testing window runs from Monday, 2 November to Friday, 4 December 2026. (Regulatory Affairs Professionals Society)
- Mar 22, 2027 – Apr 23, 2027: The Spring 2027 RAC exam testing window runs from Monday, 22 March to Friday, 23 April 2027. (Regulatory Affairs Professionals Society)
- Jun 17, 2027: The application deadline for the Summer 2027 RAC exam window is Thursday, 17 June 2027. (Regulatory Affairs Professionals Society)
- Jul 12, 2027 – Aug 13, 2027: The Summer 2027 RAC exam testing window runs from 12 July to Friday, 13 August 2027. (Regulatory Affairs Professionals Society)
- Oct 7, 2027: The application deadline for the Autumn 2027 RAC exam window is Thursday, 7 October 2027. (Regulatory Affairs Professionals Society)
- Nov 1, 2027 – Dec 3, 2027: The Autumn 2027 RAC exam testing window runs from Monday, 1 November to Friday, 3 December 2027. (Regulatory Affairs Professionals Society)
Facts verified Oct 20, 2026 against Regulatory Affairs Professionals Society. Dates that have passed are removed automatically.
- Each RAC exam (RAC-Drugs or RAC-Devices) has 120 multiple-choice questions. (Regulatory Affairs Professionals Society)
- RAC exam scores are reported on a scaled range of 0–550, so the scaled score does not show how many correct answers are needed to pass. (Regulatory Affairs Professionals Society)
- Under 2027 pricing, the RAC exam costs $620 for RAPS members and $780 for nonmembers. (Regulatory Affairs Professionals Society)
- A candidate who fails the RAC exam can retake it in the following testing window but not in the same window, and there is no limit on the number of retakes. (Regulatory Affairs Professionals Society)
- An RAC credential is valid for three years and must then be recertified. (Regulatory Affairs Professionals Society)
- The RAC exam is delivered by Pearson VUE on computer, either at an in-person test center or online with remote proctoring. (Regulatory Affairs Professionals Society)
- From 2027, RAC candidates get a preliminary pass/fail result at the test center, and RAPS releases official results about 6 to 8 weeks after the testing window closes. (Regulatory Affairs Professionals Society)
- The Autumn 2026 RAC exam testing window runs from Monday, 2 November to Friday, 4 December 2026. (Regulatory Affairs Professionals Society)
Facts verified Oct 20, 2026 against Regulatory Affairs Professionals Society. Dates that have passed are removed automatically.
RAC Exam at a Glance
| Item | Detail | Official source |
|---|---|---|
| Number of questions | 120 multiple-choice questions | Regulatory Affairs Professionals Society |
| Passing score | Scaled score, 0–550 scale | Regulatory Affairs Professionals Society |
| Exam fee | $620 RAPS member / $780 nonmember (2027 pricing) | Regulatory Affairs Professionals Society |
| Retake policy | Retake in the next window; unlimited attempts | Regulatory Affairs Professionals Society |
| Validity | 3 years | Regulatory Affairs Professionals Society |
| Delivery | Computer-based via Pearson VUE: test center or online remote proctoring | Regulatory Affairs Professionals Society |
| Score release | Preliminary pass/fail at test center; official results ~6–8 weeks after window closes | Regulatory Affairs Professionals Society |
| Registration deadline (Autumn 2027) | 7 October 2027 | Regulatory Affairs Professionals Society |
| Registration deadline (Summer 2027) | 17 June 2027 | Regulatory Affairs Professionals Society |
| Testing window (Autumn 2026) | 2 November – 4 December 2026 | Regulatory Affairs Professionals Society |
| Testing window (Autumn 2027) | 1 November – 3 December 2027 | Regulatory Affairs Professionals Society |
| Testing window (Spring 2027) | 22 March – 23 April 2027 | Regulatory Affairs Professionals Society |
| Testing window (Summer 2027) | 12 July – 13 August 2027 | Regulatory Affairs Professionals Society |
Facts verified Oct 20, 2026 against Regulatory Affairs Professionals Society. Dates that have passed are removed automatically.
Free Regulatory Affairs Certification Study Tools
Interactive Regulatory Affairs Certification resources on PracticeTestGeeks, free to start:
- Regulatory Affairs Certification flashcards — review key terms and concepts card by card
- Regulatory Affairs Certification study guide — topic-by-topic overview of what the exam covers
- Regulatory Affairs Certification cheat sheet — one-page printable summary for last-minute review
RAC Practice Test Questions
Prepare for the RAC - Regulatory Affairs Certification exam with our free practice test modules. Each quiz covers key topics to help you pass on your first try.
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RAC Exam Flashcards
Quick review for key regulatory concepts
🏛️What is 21 CFR Part 820?
Quality System Regulation (QSR) for medical device manufacturers ensuring cGMP compliance.
START RAC PRACTICE TEST🇪🇺What is the MDR?
Medical Device Regulation (EU 2017/745) governing medical devices in the European Union.
GET RAC EXAM PREP📄What is a 510(k)?
A premarket submission to FDA demonstrating a device is substantially equivalent to a predicate.
REVIEW RAC QUESTIONS🧪What is an NDA?
New Drug Application filed with the FDA to approve a new pharmaceutical for sale.
TRY RAC MOCK EXAM💊What is the Common Technical Document (CTD)?
Standard format for submitting regulatory information to health authorities (ICH region).
ACCESS RAC STUDY GUIDE⚠️What is MedWatch?
FDA's safety information and adverse event reporting program for medical products.
PRACTICE RAC TEST NOWRAC Exam Study Guide
Our RAC Regulatory Affairs Certification study guide breaks down the exam into manageable sections. Understand the RAC Certification process, including the specific requirements for RAC Devices and RAC Drugs tracks.
RAC Score Calculator
Total Scored Questions
120
84 out of 120 correct
70%
Required to Pass: ~70% (Estimated)
While the RAPS RAC Exam Fee and preparation costs can add up, the potential salary increase and career advancement opportunities often provide a high return on investment within the first year of certification.
RAC Career Opportunities
The RAC Regulatory Certification opens doors to specialized roles in the healthcare industry.
RAC Drugs Specialist
Specializes in pharmaceutical regulations, focusing on IND/NDA submissions, clinical trial compliance, and post-market drug safety monitoring.
RAC Devices Specialist
Focuses on medical device regulations including 510(k) clearances, PMA submissions, and compliance with ISO 13485 and EU MDR standards.
RAC Global Manager
Oversees international regulatory strategies, ensuring products meet compliance requirements across multiple regions like US, EU, and Asia.
RAC US
Regulatory ProfessionalExpert in FDA regulations, handling submissions and communications specifically for the United States market.
RAC EU
Compliance OfficerSpecializes in European regulations, navigating the complexities of MDR/IVDR and CE marking requirements.
RAC Test Day Checklist
- ✓Valid Government ID
- ✓Appointment Confirmation
- ✓Arrive 30 Mins Early
- ✓Review RAC Notes
- ✓Leave Electronics Behind
- ✓Comfortable Clothing
- ✓Water/Snack (Locker)
- ✓Positive Mindset
Start Your RAC Certification Journey
Don't wait to advance your career. Take our free RAC Practice Test today and get one step closer to becoming a certified regulatory professional.
RAC Recertification Requirements
Cycle
3 Years
Credits
36 RAC
Fee
$225
To keep your RAC Regulatory Affairs Certification active, you must earn 36 Regulatory Affairs Certification (RAC) credits through professional development, attendance at conferences, or authoring regulatory articles.
- +Industry-recognized credential boosts your resume
- +Higher earning potential (10-20% salary increase on average)
- +Demonstrates commitment to professional development
- +Opens doors to advanced career opportunities
- −Exam preparation requires significant time investment (4-8 weeks)
- −Certification fees can be $100-$400+
- −May require continuing education to maintain
- −Some employers may not require certification
Sample Regulatory Affairs Certification Practice Questions
Try these questions from our free Regulatory Affairs Certification practice tests. The correct answer and an explanation follow each question.
As part of due diligence for a potential company acquisition, a regulatory affairs manager is tasked with evaluating the target company's product portfolio. What is the MOST critical regulatory aspect to assess?
- A. The aesthetic design of the product's packaging and labeling.
- B. The number of employees in the target company's regulatory affairs department.
- C. The compliance status of the products, including any outstanding regulatory actions or unresolved issues with health authorities.
- D. The marketing team's budget for post-launch promotional activities.
Answer: C. The compliance status of the products, including any outstanding regulatory actions or unresolved issues with health authorities.
During due diligence, the primary concern for a regulatory professional is to assess regulatory compliance and risk. This involves reviewing the product's approval history, inspection reports, any ongoing compliance issues (like warning letters), and the overall health of the regulatory filings. These factors can represent significant liabilities and impact the product's viability and the company's valuation. While department size and marketing budgets are relevant to the business, the core regulatory risk lies in the compliance status.
A regulatory affairs professional is reviewing a complaint that could qualify as an MDR-reportable event. Which criterion makes a malfunction MDR-reportable even without causing an injury?
- A. The malfunction occurred during the warranty period
- B. The malfunction would likely cause or contribute to serious injury if it recurred
- C. The device was used off-label at the time of malfunction
- D. The malfunction was reported by more than one user
Answer: B. The malfunction would likely cause or contribute to serious injury if it recurred
A malfunction is MDR-reportable if it would likely cause or contribute to serious injury or death if it were to recur.
A key distinction between a regulatory STRATEGY and a regulatory PLAN is that a strategy:
- A. focuses only on the post-market surveillance activities required for the product.
- B. is a simple checklist of submission documents and their due dates.
- C. considers the entire product lifecycle and aligns regulatory activities with broader business objectives.
- D. is only created after a product has been rejected by a regulatory agency.
Answer: C. considers the entire product lifecycle and aligns regulatory activities with broader business objectives.
A regulatory strategy is a comprehensive, high-level document that aligns regulatory activities with business goals over the entire product lifecycle. It is proactive and considers long-term objectives, such as target markets, competitive positioning, and lifecycle management. In contrast, a regulatory plan is more tactical, focusing on the specific tasks, timelines, and deliverables required to execute the strategy, such as a submission timeline.
When creating a strategic regulatory plan, the process of gathering and analyzing publicly available information on competitor products, regulatory agency decisions, and new guidance documents is known as:
- A. Marketing research
- B. Clinical trial monitoring
- C. Regulatory intelligence
- D. Post-market surveillance
Answer: C. Regulatory intelligence
Regulatory intelligence is the process of gathering and analyzing publicly available regulatory, scientific, and legal information to inform a company's regulatory strategy. This activity helps a company understand the current regulatory landscape, anticipate changes, learn from competitors' experiences, and make more informed strategic decisions throughout the product lifecycle.
Take the full Regulatory Affairs Certification practice test
RAC Questions and Answers
Official Resources
- RAPS: Regulatory Affairs Certification (RAC) overview — official program page from the Regulatory Affairs Professionals Society
- RAPS: RAC Eligibility Requirements — official eligibility criteria for the RAC Drugs and RAC Devices exams
- RAPS: RAC Exam Registration — official registration process, testing windows, and fees
How this page was made: written with AI tools and published by Nathan Beja, founder of Practice Test Geeks, who is responsible for its content. We have not yet matched this exam's facts to an official source, so confirm fees, dates and rules with the exam body. Not reviewed by a subject-matter expert. Editorial policy