Rac us devices - Study guides, Class notes & Summaries

RAC Exam - Devices US Questions and Answers.

US RAC-Chapter 22 Questions and Answers Biological Product ANSWER Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically modified synthetic polypeptide), or analogous product... that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Public Health Service (PHS) Act 351(a) ANSWER A biologics license must be in effect for any biological product introduced or d...

RAC Device Quiz & Answers Correct Review Solution EU: Which of the following does NOT describe the CE Mark or its use? A)The CE Mark is an external indication that a device meets the Essential Requirements B)The manufacturer and/or the Notified Body have checked the device against specifications using a ConformityAssessment Procedure C) A Declaration of Conformity has been produced by the manufacturer D) The CE Mark allows the device to move freely throughout Europe only - ANS-D) The CE M...

RAC device quiz questions and answers 100% pass EU: Which of the following does NOT describe the CE Mark or its use? A)The CE Mark is an external indication that a device meets the Essential Requirements B)The manufacturer and/or the Notified Body have checked the device against specifications using a ConformityAssessment Procedure C) A Declaration of Conformity has been produced by the manufacturer D) The CE Mark allows the device to move freely throughout Europe only D) The CE Mark allows ...

RAC Prep Medical Devices Exam Prep 2023 with complete solution device - instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article: -recognized by NF-USP -intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease -intended to affect the structure or function of the body -not achieving any primary purpose through chemical action -not dependent on metabolism for primary purpose E...

US RAC Review Questions and Answers RAPS Modules 2023 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 approved dr...

US Rac Exam With 100% Questions With Correct Answers Kefauver-Harris Amendments - Answer - 1962 amendments to FD&C Act. Require drug manufacturers to prove products safe and effective prior to marketing. Gave FDA control over prescription drug advertising established GMPs and requirement of informed consent Drug Price Competition and Patent Term Restoration Act - Answer - 1984. Hatch-Waxman Act. Permitted FDA to approve ANDAs for generic drugs when patent of innovator drug expired. No anim...

DEVICE RAC 2023 Questions and Answers Graded A(Actual test) Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - C A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would ...

DEVICE RAC EXAM STUDY GUIDE Questions with 100% Correct Answers | Latest Version 2024 | Verified 510(k) Premarket Notifications for all of the following medical devices would be reviewed by CDRH's Office of Device Evaluation except: A) High Flux Hemodialyzer B) Blood specimen collection device C) Piston syringe D) Cardiopulmonary bypass blood tubing - B A 510(k) submission for any Class III device MUST include: A. Clinical results summary B. Hazards analysis evaluation C. St...

Number of Days for review of PMA - ANSWER-180 days How many routes to a PMA? - ANSWER-3 Routes: 1. 2 3 What makes a PMA unique (vs 510k)? - ANSWER--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 a big update, might reset the clock) *SSED vs 510k summary *no substantial equivalence with...