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

RAC Exam - Devices US Questions and Answers.

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 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 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...

RAC Practice Exam 1 Questions and Answers New Version 2023 Complete Which of the following is NOT required for compliance under 21 CFR Part 11 (electronic records and electronic signatures)? A Manually generated timestamped audit trails to record the date and time of operator entries and actions that create, modify or delete electronic records. B Validation of systems to ensure accuracy C Authority checks to ensure that only authorized personell can create, modify or delete electronic reco...

DIVO Fundamentals Exam 208 Questions with Verified Answers what is the SORM - CORRECT ANSWER -outlines standard Navy organization department head responsibilities - CORRECT ANSWER -represents the CO in all matters pertaining to that department -assigns personnel to station and duties within the department -coordinates the department safety program with the units safety officer -organize and train dept for battle readiness (PQS/damage control) DIVO responsibilities - CORRECT ANSWER -...

US RAC Practice Exam Questions With 100% Correct Answers [Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device? [A] Agreement meeting [B] Determination meeting [C] Presubmission meeting [D] PMA Day-100 meeting - Answer-[A] Agreement meeting /.[Q]Which meeting held with the FDA is necessary for an otherwise stalled drug product development program to proceed? [A] Type A [B] Type B [C] Ty...

DIVO Fundamentals Exam 208 Questions with Verified Answers what is the SORM - CORRECT ANSWER -outlines standard Navy organization department head responsibilities - CORRECT ANSWER -represents the CO in all matters pertaining to that department -assigns personnel to station and duties within the department -coordinates the department safety program with the units safety officer -organize and train dept for battle readiness (PQS/damage control) DIVO responsibilities - CORRECT ANSWER -...

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. Stability ...