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 Exam at a Glance

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

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.

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.

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.

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.

1. 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.

2. 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.

3. 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.

4. 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

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