RAC Devices Exam FAQs: Everything Candidates Ask Before Registering 

Researching the RAC (Devices) certification usually means piecing together answers from a dozen different pages. This is meant to be the single page that answers the questions candidates actually ask — from "is this worth it" all the way through "what happens after I pass" — with links to a deeper dive wherever one exists on our site.

General Questions

What is the RAC (Devices) certification? The Regulatory Affairs Certification (RAC) Devices is a professional credential administered by the Regulatory Affairs Professionals Society (RAPS) for individuals working in medical device and IVD regulatory affairs. It's a voluntary, NCCA-accredited certification — not a government license — that validates knowledge of device regulation across the full product lifecycle. For a fuller introduction, see What Is RAC Devices and Why You Should Consider Taking This Exam.

What's the difference between RAC Devices and RAC Drugs? They're separate designations under the same RAC program. RAC Devices covers medical devices and IVDs; RAC Drugs covers pharmaceuticals, biologics, APIs, and related products. The two exams have different content outlines and, since 2026, different domain structures — RAC Devices has four domains, RAC Drugs has five. Candidates can pursue one or both, depending on their career focus.

Is the RAC required to work in medical device regulatory affairs? No. No regulator requires it, and it grants no legal authority. It's valued because employers and hiring managers recognize it as a credible signal of regulatory competency — where it carries weight, it's because a specific employer or role asks for it, not because of any regulatory mandate.

Is RAC Devices worth it? That depends on your career goals, but RAC-certified professionals are generally reported to have stronger positioning for hiring and promotion decisions in regulatory affairs, particularly at senior levels, along with the credibility of an NCCA-accredited, third-party-validated credential.

Eligibility Questions

Who is eligible to sit for the RAC Devices exam? You qualify under one of three paths: a bachelor's degree with 3 years of regulatory-related experience, a master's degree with 2 years, or a doctoral degree with 1 year. Full details are in our Cost, Eligibility & Registration Guide.

Does my experience have to be in a job titled "regulatory affairs"? No. RAPS defines regulatory-related experience broadly — quality assurance, quality control, clinical research, and regulatory project management tied to bringing a healthcare product to market can all count, as long as it's relevant to devices and IVDs.

Can I see who else has earned RAC Devices in my field? Our List of RAC (Devices) Qualified Professionals is a useful reference if you want a sense of the professional community around this credential.

Cost & Registration Questions

How much does the RAC Devices exam cost? Per the current 2026 fee schedule, $605 for RAPS members and $760 for non-members. See our full cost breakdown for transfer fees and other details.

Is it worth joining RAPS before I apply? Often, yes — the $155 member discount on the exam fee can offset some or all of the cost of joining, especially if you'll also use other RAPS resources.

When are the RAC Devices testing windows? RAPS runs three windows a year: Spring, Summer, and Autumn, each with a registration deadline roughly six weeks before the window opens. Exact dates are published on raps.org and summarized in our registration guide.

How do I actually register? Applications and payment go through raps.org/certify-advance before your chosen window's deadline. Once approved, you schedule your exam appointment with Pearson VUE, either in-person or via online proctoring.

Exam Format & Scoring Questions

How many questions are on the RAC Devices exam, and how long is it? 120 multiple-choice questions in a 2.5-hour session — a format RAPS introduced starting with the Spring 2026 testing window.

What score do I need to pass? RAPS uses a scaled score from 0 to 99, with 75 required to pass. It's not a raw percentage — the scaling accounts for differences in difficulty across exam forms.

What's the RAC Devices pass rate? RAPS doesn't publish an official number, but a range of roughly 40–50% is widely cited across regulatory training resources. Structured, weighted preparation is the most controllable way to improve your odds against that baseline.

Domain & Content Questions

What domains does the RAC Devices exam cover? Four, as of the 2026 restructuring: Strategic Planning (~27%), Design and Development (~27%), Process for Licensing, Registration, and Renewals (~23%), and Post-Market Activities (~23%). See our full domain breakdown for what each one actually tests.

Did the exam domains change recently? Yes. Starting with the Spring 2026 window, RAPS renamed and rebalanced the domain structure alongside expanding the exam itself. Study material still organized around the pre-2026 structure can leave gaps in exactly where the current exam concentrates questions.

Is there a separate ethics section? No — professional ethics is tested as required knowledge running through all four domains rather than as its own scored section.

Does the exam cover regulations outside the U.S.? Yes. The RAC Devices exam tests global, lifecycle-based regulatory knowledge, not just FDA requirements — candidates should expect content touching EU MDR/IVDR and other major frameworks alongside U.S. regulations.

Study & Preparation Questions

How long should I study for the RAC Devices exam? It depends on your existing regulatory experience, but many candidates use a structured plan in the 60–90 day range. See our 90-Day Study Plan for a week-by-week approach weighted to the current domain structure.

What study tips actually help? Our Study Tips for RAC (Devices) page covers practical strategies, and our 90-Day Study Plan breaks those into a concrete schedule.

Should I use practice questions, or just read study material? Both — but don't skip practice questions. RAC exam questions lean heavily on applying knowledge to scenarios rather than pure recall, so passive reading alone under-prepares you for how the exam is actually structured. See our RAC Devices Practice Test page and Study Material overview.

What should I look for in a study guide? Currency to the 2026 exam format, coverage that tracks the real domain weighting, well-explained scenario-based questions, and global regulatory scope — not just page count. The AptSkill RAC Devices Master Handbook was built specifically around these criteria.

Results, Recertification & Career Questions

When do I get my RAC Devices exam results? RAPS typically releases results some weeks after your testing window closes, sent directly to candidates.

Does the RAC Devices credential expire? Yes — it's valid for three years, after which you need to recertify by earning 36 recertification credits (through continuing education, publishing, speaking, or professional service) or by retaking the exam if your certification lapses beyond the grace period.

Do I need to recertify separately if I hold both RAC Devices and RAC Drugs? No — professionals holding both credentials submit one combined recertification application covering both, still based on the same 36-credit, three-year cycle.

Does RAC Devices certification actually help my career? It's generally associated with stronger positioning in hiring and promotion within regulatory affairs, and it signals ongoing professional competency through its recertification requirement — though actual impact varies by employer, seniority, and region.

Ready to Start Preparing?

If you've worked through the questions above and you're ready to commit to a study plan, the next steps are straightforward: confirm your eligibility and registration details in our Cost, Eligibility & Registration Guide, review what the exam actually tests in our Domains Explained guide, and build your schedule with our 90-Day Study Plan — backed by the AptSkill RAC Devices Master Handbook, rebuilt specifically for the current exam format.

Exam fees, dates, format, and recertification requirements are set by RAPS and can change between cycles. This page reflects the published schedule and requirements as of late 2026 — always confirm current details at raps.org before registering.