CRAP Study Guide 2026
Everything you need to pass the CRAP exam in one place: the exam format, every topic to study, real practice questions with explanations, flashcards, and full-length practice tests. Free, no sign-up needed.
📋 CRAP Exam Format at a Glance
📚 CRAP Topics to Study (69)
✍️ Sample CRAP Questions & Answers
1. During the Design Control process under 21 CFR Part 820, which document formally captures the intended use and user needs before design specifications are written?
Design Input requirements translate user needs and intended use into specific technical requirements before the design process begins.
2. A company discovers a post-market safety issue requiring a recall. Under 21 CFR Part 7, what is the highest level of recall classification?
Class I recall is the most serious, indicating a reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death.
3. Under 18 USC § 1001, making a materially false statement to FDA is a federal crime punishable by:
18 USC § 1001 makes materially false statements to any federal agency, including FDA, punishable by up to 5 years imprisonment plus fines.
4. How should risks be prioritized?
Prioritizing by probability and impact ensures resources are allocated to the risks most likely to cause significant harm, maximizing risk management effectiveness.
5. Under FDA regulations, which outcome qualifies an adverse event as 'serious'?
A serious adverse event is defined as one resulting in death, life-threatening conditions, inpatient hospitalization, significant disability, congenital anomaly, or requiring medical intervention to prevent permanent harm.
6. In the context of combination products in the US, what determines the regulatory pathway (drug, device, or biologic) for a combination product?
FDA assigns a combination product to an agency center based on the primary mode of action of the combination product as a whole.