Rac devices - Study guides, Class notes & Summaries

1. Which division has primary jurisdiction over a vascular graft with an antibi- otic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP ANS : 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. 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 de...

RAC devices practice exam Questions and Answers (Latest Update 2025)

RAC DEVICES exam questions and answers 2025.

RAC Devices Exam Questions and Answers 2022 with Complete Solutions What is a modular PMA? - Answer- Same content as a traditional PMA but the sections are submitted and reviewed as the work is completed. What is a PDP? - Answer- Product Development Protocol. Alternate to a PMA where you plan the design and timelines for product development up front with FDA and send updates When is a PMA supplement needed? - Answer- Significant changes to product such as indications, labels, mfg loc...

RAC Exam Prep - EU MDD/AIMDD & MDR 2024 with complete solution;(Study Aid - RAC) Similar but more detailed than the Essential Requirements - Answer ️️ -General Safety and Performance Requirements This ISO standard includes the most recent update to specific medical device companies quality management system? - Answer ️️ -13485:2016 Which entity affixes it's identification number near the CE Mark? - Answer ️️ -Notified Body, if involved in the conformity assessment Un-classif...

RAC Devices Exam with correct answers

RAC DEVICES PRACTICE EXAM

RAC DEVICES Exam Prep 2024 | 60 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+

RAC devices EU 2024 | Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+

What did the safe medical device act do? Answer - Extended AE reporting to user facilities, required 510ks with SE, recall authority General controls Answer - Establishment reg and device listing, GMP, labels, clearance before marketing What controls are required by the 3 US classes? Answer - Class 1 - general controls. Class 2- General and special controls (which include special labeling, PMS, and performance data) Class 3- general, special, and PMA What are special controls? Answer...