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RAC Bundled Exams with Complete Solution | Verified | Guaranteed Success

RAC Bundled Exams with Complete Solution | Verified | Guaranteed Success

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DEVICE RAC EXAM | Questions with 100% Correct Answers | Verified | Latest Update 2024

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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 - C A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamenta...

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Device RAC Exam Study Guide | Questions with 100% Correct Answers & Explanations | Verified | Latest Update 2024

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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 - 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 supportiv...

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FDA Time Frames (Device) RAC Exam | 100% Correct | Verified | Latest Update 2024

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Facility Registration - Devices - within XX days of application or manufacturing - 30 days Facility Re-Registration - Devices, Drugs & Biologics - Annual GLP & GCP Record Retention - 5 Years - from application or 2 Years - from approval or termination date IND/IDE (GCP) - Progress Report - Repor...

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RAC Exam Prep - EU MDD/AIMDD & MDR | Verified | Latest Update 2024

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Similar but more detailed than the Essential Requirements - General Safety and Performance Requirements This ISO standard includes the most recent update to specific medical device companies quality management system? - 13485:2016 Which entity affixes it's identification number near the CE Mark...

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RAC Practice Exam 1 | 100 Questions with 100% Correct Answers | Verified | Latest Update 2024

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Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of s...

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RAPS Practice Test | Questions with 100% Correct Answers | Verified | Latest Update 2024

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A company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and finds one site has not consented 1/3 of its subjects properly. What is the FIRST thing the company needs to do? A. Stop the entire study B. Inform FDA and ask for guidance C. Re-train the s...

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RAC Sample Test | 100 Questions with 100% Correct Answers | Verified | Latest Update 2024

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Which of the following is considered part of the Device Master Record? A. Employee training record B. Labeling specifications C. Design reviews D. Calibration records - B. Labeling specifications Question Feedback: Labeling specifications are part of the DMR A company has a new oral drug, GOOD...

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US RAC Review - RAPS Modules | Questions with 100% Correct Answers | Verified | Latest Update 2024

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In which situation is an IND not required? A) You intend to conduct a clinical trial with an investigational new drug B) You intend to conduct a clinical trial with an approved drug to support a marketing application for a new indication C) You intend to collect blood samples from subjects to lo...

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