Rac 2016 us rac - Study guides, Class notes & Summaries

RAC 2016 US RAC Practice Exam 2024 | 100 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+

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 2016 US RAC Practice Exam 2024 | 100 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment with an approved device. This side effect is not listed in the package insert. This event must be reported by the manufacturer to FDA no later than: A. 5 calendar days. B. 15 calendar days. C. 30 calendar days. D. The next quarterly or annual report. - Explanation: B. T...

Renewal application NIH (aka Competing Continuation) Request for an additional period of support based on a previously funded project; compete with other competing continuation, competing supplemental, and new applications for funds; If not funded, must use the "new" application to reapply and continuity with previous award will not be retained. Resubmission NIH An unfunded application that has been modified following initial review and resubmitted for new consideration. FCOI Financial Co...

RAC 2016 US RAC Practice Exam Questions with Correct Answers Guaranteed Pass 100% Download A 510(k) submission for any Class Ill device MUST include: A. Clinical results summary. B. Risk analysis. C. Stability evaluation, D. Certification and summary. - Answer -Explanation: Although the design control regulations applicable to all Class III devices require risk analysis as part of design validation (21 CFR 820.30(g)), the risk analysis is not required to be included in Class Ill 510(k)s...