Rac us devices - Study guides, Class notes & Summaries

RAC EXAM QUESTIONS WITH 100% CORRECT ANSWERS A deficiency letter may be issued to a company during a Biologics License Application (BLA) review for which of the following? - Answer- Clinical testing did not include enough subjects Company X is developing marketing materials for a Class II medical device known as "Y." In one marketing piece, the company talks about the clinical data supporting the device's marketing. Which of the following statements is illegal and should NOT be inc...

RAC Exam - Devices US UPDATED Exam Questions and CORRECT Answers Regulations - Correct Answer- interpret laws and describe how they will be enforced guidance document - Correct Answer- used to convey FDA's current thinking or enforcement priorities - not legally binding Sherley Amendment - Correct Answer- prohibited labeling medicines with false therapeutic claims intended to defraud the purchaser Pure Food and Drug Act of 1906 - Correct Answer- prohibited misbranded and adulterated ...

US RAC Review Questions And Answers 2024 RAPS Modules Updated with Complete Solution. 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 look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your appr...

US RAC Practice Exam 2016 Test Bank Questions and Answers All Correct (Verified Answers) According to the Quality System Regulations, re-testing and re-evaluation of nonconforming devices after rework activities must be documented in the: A. Device history record. B: Device master record. C. Complaint files. D. Design history file. - Explanation: A. This contains the dates of manufactured, the quantity manufactured, the quantity released for distribution, control numbers used and the ...

RAC Exam - Devices US (Answered) Correctly!!

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...

US RAC Review Questions And Answers 2024 RAPS Modules Updated with Complete Solution. 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 look for biomarkers or pharmacogenetic information D) You intend to conduct a clinical trial using 2 of your appr...

RAC Devices Exam Prep-US High Risk 2024 | Questions with 100% Correct Answers | Verified | Latest Update | Graded A+ Number of Days for review of PMA - 180 days How many routes to a PMA? - 3 Routes: 1. 2 3 What makes a PMA unique (vs 510k)? - -Must include section on clinical investigations on human subjects -Must include a seperate volume on QS for review by CDRH/OC (office of compliance) -Includes a premarket QMS inspection -Sponsor should update the PMA periodically during review (if...

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 ...