Rac medical devices exam - Study guides, Class notes & Summaries

US RAC Exam Prep Questions and Answers | Latest Update | 2024/2025 | Already Passed Describe the purpose of a New Drug Application (NDA). The NDA is submitted to the FDA to request approval for marketing a new pharmaceutical in the U.S. What is the purpose of a combination product in regulatory terms? It involves two or more regulated components, such as a drug and device, that work together. Explain what an Orphan Drug Designation provides to a company. It grants incentives lik...

RAC Prep Medical Devices Exam Prep 2023 with complete solution

RAC Exam New Edition 2024 Solved Correctly drug - Answer ️️ -Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - Answer ️️ -An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on...

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 Exam New Edition 2024 Solved Correctly drug - Answer ️️ -Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - Answer ️️ -An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on...

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 PREP MEDICAL DEVICES EXAM QUESTIONS AND ANSWERS (VERIFIED ANSWERS BY EXPERT)

RAC Exam Study Guide with Complete Solutions drug - Correct Answer Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - Correct Answer An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on...

RAC Devices Core Exam Questions and Answers All Correct The Medical Device User Fee and Modernization Act of 2002 - Answer- authorized FDA to assess fees for the review of premarket submissions The following changes were included in the 2007 amendment to the Medical Device Directives (2007/47/EC) - Answer- - additional clinical data requirements - labeling requirements custom-made device in Europe - Answer- a device intended for the sole use of a particular patient criteria that ...

RAC Exam New Edition 2024 Solved Correctly drug - Answer ️️ -Any article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man. medical device - Answer ️️ -An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or similar or relate article, including any component, part or accessory intended for the use in diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease on...