Rac drugs final exam - Study guides, Class notes & Summaries

RAC Practice Exam 2 -HJ Questions & Answers You work for a German-based device manufacturer (Company A) that produces a power supply based on a US-based medical device company's (Company B) design. The power supply is imported into your company's US-based manufacturing site (Company C) for further processing and then sent to the USbased medical device company (Company B) for final assembly. Which company needs to register with FDA: A. Company A B. Company B C. Company A &B D. Compa...

RAC Practice Exam Latest Updated 2024 With Complete Solutions You have modified your 510(k)-cleared device with a Special 510(k). In which case would a Special 510(k) not be appropriate for the device? -You have changed the primary mechanism of action. Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption? - Real Time Supplement A medical device company allows its sales force to maintain a product inventory in the field. The device has an expir...

FDA Time Frames (Device) RAC Exam Questions and Answers 100% Solved Facility Registration - Devices - within XX days of application or manufacturing 30 days Facility Re-Registration - Devices, Drugs & Biologics Annual GLP & GCP Record Retention 5 Years - from application or 2 Years - from approval or termination date IND/IDE (GCP) - Progress Report - Reporting requirements Sponsor report to FDA & IRB Investigator reports to Sponsor & IRB Annual - 60 days from anniversary IND & IDE - time al...

RAC Practice Exam Latest Updated 2024 With Complete Solutions You have modified your 510(k)-cleared device with a Special 510(k). In which case would a Special 510(k) not be appropriate for the device? -You have changed the primary mechanism of action. Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption? - Real Time Supplement A medical device company allows its sales force to maintain a product inventory in the field. The device has an expir...

RAC Practice Exam Latest Updated 2024 With Complete Solutions You have modified your 510(k)-cleared device with a Special 510(k). In which case would a Special 510(k) not be appropriate for the device? -You have changed the primary mechanism of action. Which Premarket Approval Application (PMA) supplements are NOT subject to user fee exemption? - Real Time Supplement A medical device company allows its sales force to maintain a product inventory in the field. The device has an expir...

CMCA PRACTICE EXAM 136 Questions with Verified Answers The Joint Commission (JC) requires the Factors that Affect Learning must be assessed for a hospital or hospital owned physician practice as well as other health care facilities. When assessing this element what does this include? A. The patient's ability to read, method of learning and understanding. B. Any language or physical disabilities. C. Cultural beliefs. D. All the above - CORRECT ANSWER D. All the above Report cop...

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...

RAC Exam practice test bank 2023 all possible questions and answers with complete solution Which of the following was NOT a requirement of the original Food Drug and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - A: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham-Humphrey Amendments b) Hatch-Waxman Act c) Controlled Substance...

DIVO FUND Exam 194 Questions with Verified Answers Describe the six core principles of SSOP - CORRECT ANSWER Formality, Forceful backup, Procedural compliance, Integrity, Questioning attitude, Level of Knowledge Describe the three supporting processes to SSOP - CORRECT ANSWER Operational risk management, incident reporting, Planning Briefing Executing Debriefing (PBED) Describe the four steps of the plan, Brief, Execute, Debrief (PBED) Process - CORRECT ANSWER 5Ws. Constrains, restraint...

NAB Exam Review - Finance/HR/Environment/Regulatory Agencies/Medical terms/Staffing/Labor laws Which psychological factor is normally not a problem with the aging? Which psychological factors is normally a problem with the aging? Ans- Self-actualization. Paranoia, Depression, Feelings of worthlessness. Which statements concerning the needs of the elderly is true? Ans- Relationships are need to combat loneliness. The need for closeness is never lost by most of the elderly. Independen...