The RAC examinations were updated beginning with the Spring 2026 testing window.

The updated exam remains multiple choice, but the number of questions increased from 100 to 120, and the time limit increased from two hours to two and a half hours. RAPS stated that the update was intended to keep the exam aligned with current regulatory professional practice.

The current format is therefore:

Exam element	2026 format
Number of questions	120
Time limit	2 hours 30 minutes
Format	Multiple choice
Delivery	Computer-based
Testing provider	Pearson VUE
Credential earned	RAC-Devices

Candidates have approximately 75 seconds per question on average.

That sounds manageable, but scenario-based questions can take considerably longer than simple recall questions.

Time management is therefore an important part of preparation.

What Types of Questions Appear on the Exam?

Historically, RAC questions have tested three levels of thinking:

1. Recall Questions

Recall questions test whether the candidate recognizes or understands specific regulatory information.

These may involve:

• Definitions
• Regulatory roles
• Submission pathways
• Required documents
• Timelines
• General requirements
• Regulatory terminology

A simple example might ask which authority is responsible for a particular type of review or which document is required at a specific lifecycle stage.

Recall questions are usually the most direct, but candidates should not assume that every fact must be memorized word for word.

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2. Application Questions

Application questions ask the candidate to use regulatory knowledge in a realistic professional situation.

For example:

A manufacturer plans to change the sterilization site for an approved medical device. What should the regulatory professional do first?

Several answers may sound reasonable.

However, the best response may be to assess the change against the applicable market authorizations before implementation.

These questions test whether the candidate understands when and how a requirement applies.

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3. Analysis Questions

Analysis questions are more complex.

They may present a short case containing:

• Product information
• Market strategy
• Clinical or performance data
• Manufacturing changes
• Regulatory concerns
• Post-market signals
• Conflicting internal priorities

The candidate must identify the most appropriate regulatory strategy or action.

For example:

A medical device company receives increasing complaints involving a potential patient-safety risk in several markets. Which action should the regulatory professional recommend first?

The candidate may need to consider complaint evaluation, reportability, risk assessment, escalation, authority notification, and possible field action.

The challenge is that several options may be technically possible.

The examination asks for the best answer.