Rac questions and answers - Study guides, Class notes & Summaries

RAC Drugs Final Exam 2024 | 40 Questions with 100% Correct Answers | Verified | Latest Update | Graded A+ (EU) MA - Market Authorization or product license issued by health authority. Valid for 5 years and subject to 1 renewal. 4 EU procedures to obtain an MA - National, centralised, mutual recognition, decentralized procedures MAH - A legal person or legal entity who must be established in the European Economic Area comprising of 28 member states. What does an MA include? - Active substance...

RAC Medical Devices Exam Questions and Answers With Complete Solutions,RAC Medical Devices Exam Questions and Answers With Complete Solutions,RAC Medical Devices Exam Questions and Answers With Complete Solutions,RAC Medical Devices Exam Questions and Answers With Complete Solutions

Device RAC Exam Questions and Answers 2023-2024 with complete solution

RAC Exam practice test bank 2023 all possible questions and answers with complete solution

Latest Device RAC Exam Questions and Answers 2023-2024 1. 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 2. A company wants to modify its legally marketed device such that the mod- ification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this c...

When is an NDA annual report due? - ANS-60 days after the anniversary date of U.S. approval of the application. NDA Reporting Period ? All Blood and HCT/P Problems - ANS-45 calendar days of Fatal/Life threateneing/Disabling/Surgical Intervention and hospitalization Reporting Period? Postmarket Device Death, Serious Injury, Malfunction - ANS-Within 30 calendar days of awareness Reporting Period? Device Special FDA, or Remedial Action to Prevent Death/Harm - ANS-Within 5 work days of aw...