RAC Cheat Sheet 2026

The 30 highest-yield RAC facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. In GMP terms, what distinguishes a 'critical process parameter' (CPP) from a general process parameter? → Variation in a CPP directly impacts a critical quality attribute of the product
2. A manufacturer wants to market a Class II device that is substantially equivalent to a predicate device cleared in 1995. Which submission type is required? → 510(k)
3. Which FTC standard applies when an advertiser claims a product produces a specific quantified outcome (e.g., 'Lose 10 lbs in 2 weeks')? → Competent and reliable scientific evidence that the specific result is typical for users
4. What is the main function of the EUDAMED database in EU MDR post-market surveillance? → Centralized European database for device registration, UDI, and vigilance reporting
5. Which ICH guideline specifically addresses the stability testing of new drug substances and products? → ICH Q1A(R2)
6. Which action is required when a manufacturer's PMS data shows that a device's benefit-risk profile is no longer acceptable? → Initiate a field safety corrective action and notify relevant competent authorities
7. Which FDA submission type is used to request approval for a generic drug product? → ANDA
8. Which provision of the FD&C Act allows FDA to require Risk Evaluation and Mitigation Strategies (REMS) for drugs that pose serious safety risks? → Section 505-1, added by FDAAA 2007
9. A sponsor submits an NDA for a new drug. FDA issues a Complete Response Letter (CRL). What does this signify? → FDA has determined the application is not approvable in its current form
10. Under 21 CFR Part 601, which FDA center primarily reviews BLAs for therapeutic biological products such as monoclonal antibodies? → Center for Drug Evaluation and Research (CDER)
11. Which of the following BEST describes the role of the Qualified Investigator (QI) in Canada under ICH GCP? → The individual responsible for the conduct of a clinical trial at the trial site
12. Under 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), a Quality Assurance Unit (QAU) inspection of a study must be conducted: → At intervals adequate to ensure integrity, including at critical study phases
13. What is the role of the European Medicines Agency (EMA)? → Evaluate medicines in the European Union
14. What is a key responsibility of regulatory affairs professionals? → Ensure regulatory compliance
15. Design validation under 21 CFR Part 820 must be performed under which conditions? → Simulated or actual use conditions
16. Which document formally establishes the acceptance criteria used to evaluate validation results? → Validation protocol
17. Which of the following is a required basic element of informed consent for a clinical trial, as specified in 21 CFR 50.25? → A disclosure of appropriate alternative procedures or courses of treatment, if any.
18. Under 21 CFR Part 312, a sponsor who transfers all obligations to a CRO must ensure which of the following? → A written agreement describing the transfer of responsibilities exists
19. Which section of a Common Technical Document (CTD) contains the clinical study reports? → Module 5
20. Under FDA's postmarket surveillance authority (21 CFR Part 822), which device classification typically triggers a mandatory postmarket surveillance study order? → Class III devices or Class II devices presenting serious adverse health consequences
21. Which IND type allows a sponsor to ship an investigational drug to clinical investigators without a 30-day FDA review period? → Emergency IND
22. Under FDA's risk-based approach to device classification, a Class III device requires which type of premarket review? → Premarket Approval Application (PMA)
23. Which ICH guideline addresses the timing and extent of carcinogenicity studies needed to support clinical development of pharmaceuticals? → ICH S1A
24. Under the Common Rule (45 CFR Part 46), which category of research qualifies for exemption from full IRB review? → Survey research involving adults where responses are recorded anonymously
25. When FDA issues an 'Additional Information' (AI) request during a 510(k) review, what happens to the review clock? → It is suspended until the sponsor responds
26. Which section of a PMA application contains the results of all clinical investigations used to support device safety and effectiveness? → Section 6 – Clinical investigations
27. Which internal department is most often engaged during regulatory planning? → Clinical and R&D teams
28. Under 21 CFR Part 11, which control is REQUIRED for electronic records used in regulatory submissions? → Audit trails that capture who made changes, what was changed, and when
29. When planning a regulatory strategy for an orphan drug in the US, which benefit is most strategically valuable? → Seven years of market exclusivity post-approval
30. Under 21 CFR Part 211, which document must be prepared and followed for each batch of drug product? → Batch production record