DEVICE RAC Exam Questions and Answers 2025/2026

DEVICE RAC Exam Questions and Answers

11. Under 21 CFR 812, the IDE regulation, which of the following statements is FALSE? A. Investigator shall report withdrawal of approval by the IRB to sponsor within 5 working days. B. Investigator shall report device use without informed consent to sponsor and IRB within 10 working days after use occurs. C.The sponsor shall notify FDA within 30 working days of the completion or termination of an investigation for a sig risk device. D. An investigator shall submit to the sponsor and IRB a report of any unan- ticipated adverse device effect within 10 working days after the investigator first learns of the effect.: B. Investigator shall report device use without informed consent to sponsor and IRB within 10 working days after use occurs. The investigator shall report device use without obtaining informed consent to the sponsor and the reviewing IRB within 5 working days after the use occurs. See 21 CFR 812.150(a)(5). 12. When a manufacturer is performing design validation activities, which element is NOT included as a requirement under device design validation section of the QSR? A. Conformance to defined user needs and intended uses B.Testing of production units under actual or simulated use conditions C. Software validation D.Translation of device design into production specifications: D.Translation of device design into production specifications Translation of device design into production specifications is covered under 820.30(h) Design transfer. 13. A manufacturer which of the following must file an IDE before conducting a human clinical study? A. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time B. A device intended solely for veterinary use C. A custom device being studied for safety and effectiveness in support of commercial marketing D. A device in commercial distribution before 28 May 1976 when used or investigated in accordance with its indications in labeling in effect at that time and intended solely for veterinary use: C. A custom device being studied for safety and effectiveness in support of commercial marketing While a custom device may be studied in humans without an IDE, if its safety and efficacy are being studied in support of commercial marketing, an IDE must be filed; see 21 CFR 812.2(c)(7). 14. The initial importer of a medical device MUST: A. Report incidents in which a device may have caused or contributed to a death or serious injury B. Maintain quality assurance files C. Share responsibility for submittals with other distributors D. Report device malfunctions in an annual report: A. Report incidents in which a device may have caused or contributed to a death or serious injury