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

A medical device manufacturer is preparing a submission that requires a Declaration of Conformity with design control requirements. What type of submission is the manufacturer preparing to submit to FDA? 0 A PMA 1 A Special 510(k), 2 An Individual Device Exemption (IDE), 3 An Annual Report for a PMA - A Special 510(k) A company wishes to expand existing labeling for a medical device to include a new indication for use. What action should the regulatory professional take FIRST? - Contact t...

RAC devices practice exam Questions and CORRECT Answers 2024/2025

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...

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 ...

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 DEVICES EXAM |NEWEST PRACTICE EXAM 2024 |ACTUAL COMPLETE QUESTIONS AND CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) |PRE-ASSESSED A+

RAC Practice Exam Questions and Answers | Latest Update | 2024/2025 | 100% Pass What is the primary purpose of regulatory affairs? A) To ensure product marketing strategies are effective B) To ensure compliance with laws and regulations in healthcare C) To manage sales and distribution D) To enhance customer service practices Which of the following is a common requirement for premarket approval of medical devices? A) Completion of an annual report B) Submission of clinical data...