Rac us devices - Study guides, Class notes & Summaries

RAC US Devices Exam Questions and Answers All Correct What is a device recall? - Answer- generally a voluntary action by sponsor can be requested by FDA likely need to report to FDA device recall classes - Answer- class 1: use will cause serious adverse health consequences class 2: use may cause temporary adverse health consequence class 3: use not moment to cause serious adverse health consequences 180 day PMA supplement - Answer- change affects safety and effectiveness ...

RAC Exam - Devices US Questions and Answers (Graded A)RAC Exam - Devices US Questions and Answers (Graded A)RAC Exam - Devices US Questions and Answers (Graded A)RAC Exam - Devices US Questions and Answers (Graded A)RAC Exam - Devices US Questions and Answers (Graded A) Regulations - ANSWER-interpret laws and describe how they will be enforced guidance document - ANSWER-used to convey FDA's current thinking or enforcement priorities - not legally binding Sherley Amendment - ANSWER-prohib...

RAC Devices 2024/2025 Questions and Answers 100% CorrectRAC Devices 2024/2025 Questions and Answers 100% CorrectRAC Devices 2024/2025 Questions and Answers 100% CorrectRAC Devices 2024/2025 Questions and Answers 100% CorrectRAC Devices 2024/2025 Questions and Answers 100% CorrectWhat 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, clearan...

RAC US devices Exam (Version 2) (Questions & Answers with rationale) (Latest updated do IDE devices require cgmp compliance? - Answer -no cgmp compliance required for IDE devices abbreviated IDE - Answer -doesn't require FDA approval non significant risk devices or studies only supplement IDE submissions required for charges to: - Answer -investigational plan informed consent other substantive info when is a special 510k used? - Answer -when a sponsor wants to modify their own ...

RAC Devices Exam Prep-US High Risk 2024 | Questions with 100% Correct Answers | Verified | Latest Update | Graded A+

RAC Devices Exam Prep-US High Risk 2024 | Questions with 100% Correct Answers | Verified | Latest Update | Graded A+

RAC Exam - Devices US Questions and Answers

RAC 2016 US RAC Practice Exam Questions and Answers | Latest Update | 2024/2025 | 100% Pass What is the primary focus of the FDA's Good Manufacturing Practices (GMP)? A) To reduce costs in manufacturing B) To ensure quality and safety in the production of medical devices C) To speed up the approval process D) To enhance marketing strategies What is the main purpose of a Risk Management File? A) To list all marketed devices B) To document identified risks and mitigation strateg...

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...