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DEVICE RAC EXAM 2026 | Questions with 100% Correct Answers | Verified | Latest Update 2026| Graded A+

DEVICE RAC EXAM QUESTIONS With correct Answers (100% VERIFIED) Latest Update 2026/2027 | Graded A+. 510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except: A) High Flux Hemodialyzer B) Blood specimen collection device C) Piston syringe D) Cardiopulmonary bypass blood tubing - ANSWER: B A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter...

Device Rac Exam Questions With 100% Correct Verified Answers | Latest Update 2026/2027 | Graded A+. A legally marketed device to which equivalence is drawn in a premarketing submission is known as the: A. Comparator device B. Predecessor device C. Predicate device D. Substantially equivalent device -correct-answer-C A company wants to modify its device such that there is a major change to the fundamental scientific technology of the device. The FDA has published a guidance on this techn...

DEVICE RAC EXAM QUESTIONS AND ANSWERS | 100% SOLVED | LATEST UPDTAE 2026/2027 | VERIFIED. 1. If your firm commercially distributes a Class III device that is subject to PMA requirements without an approved Pre-market Approval Application, what is the statutory violation? A) Adulteration B) Improper Use C) Misbranding D) Idiocy - correct answer - A 2. Pre-market Notification Requirements would apply to a device that is: A) Substantially equivalent to a pre-amendment device B) Intended ...

DEVICE RAC EXAM QUESTIONS WITH VERIFIED ANSWERS LATEST UPDATE 2026/2027 (100% SOLVED) Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - Correct Answer - C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case. A company wants to modify its legally marketed device such that the modificatio...

Device RAC Exam Questions with Answers (100% Correct Answers)

DEVICE RAC EXAM QUESTIONS (Latest Version) With Correct Answers |Already A+ Graded(100% Pass)

Device RAC Exam 2026 Complete Questions and Answers Pass the Exam, 100% Verified (2025 / 2026) Graded A+ This document provides a comprehensive study guide for the Device RAC Exam. It includes exam-style practice questions, accurate answers, and detailed explanations to help candidates review regulatory requirements, compliance standards, and device-specific knowledge. Designed to support effective preparation and ensure success on the RAC certification exam. Device RAC Exam study guide, RAC ex...

DEVICE RAC EXAM QUESTIONS (2025) ACTUAL EXAM (TESTING REAL EXAM QUESTIONS) AND VERIFIED ANSWERS (MULTIPLE CHOICES) |COMPLETE SOLUTIONS /. Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - Answer-C /.A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. I...

DEVICE RAC EXAM QUESTIONS With correct Answers (A+ GRADED 100% VERIFIED) 2025/2026