What is a device recall - Study guides, Class notes & Summaries

SOCRA EXAM PREP | 2024 / 2025 Newly Updated | Questions and Verified Answers | Highly Rated Guide Q: What 4 aspects of a trial should a sponsor focus on when monitoring for compliance per 21 CFR 312.56? Answer: 1) Progress of investigations under IND 2) Secure compliance or discontinue investigators that are not compliant and notify FDA 3) Review safety/effectiveness of drug and report safety issues to FDA + make annual reports or progress 4) Notify FDA, all IRBs and all investigators if drug pr...

RAC US Devices Exam Questions and Answers All Correct What is a device recall? - Answer- generally a voluntary action by sponsor can be requested by FDA likely need to report to FDA device recall classes - Answer- class 1: use will cause serious adverse health consequences class 2: use may cause temporary adverse health consequence class 3: use not moment to cause serious adverse health consequences 180 day PMA supplement - Answer- change affects safety and effectiveness ...

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 records. D Establishment of and adherence to written procedures - Answe...

WGU C475 Care of Old Adult Study Guide Questions and Answers 2024/2025 (Verified Answers). Which of the following statements is true about serious chronic illnesses? The majority of annual US health care spending goes towards chronic illness What should drive decision making in palliative care? Patient goals of care Mr. R tells you that he is frightened by not knowing what happens after death. Which domain of quality of life is being affected by his serious illness? Spiritual Which st...

CRCST Exam Test Prep 150 Questions And Answers 2023 Which agency provides standards for the Installation of Sprinkler Systems in Central Service department? - Correct answer-NFPA (National Fire Protection Association) K-wire is used for which of the following procedures? - Correct answer-Orthopedic Which of the following is considered a critical device? - Correct answer-Retractors The final phase of Ethylene oxide sterilization cycle is: - Correct answer-Aeration Which of the following st...

Device RAC Exam Questions and Answers | Latest Update | 2024/2025 | Already Passed What is the role of regulatory affairs professionals in the medical device industry? A) To ensure compliance with regulations and guidelines B) To create marketing strategies C) To design medical devices D) To conduct clinical trials What does a De Novo classification request pertain to? A) Devices that are already on the market B) Devices that are novel and have no predicate C) Devices undergoing...

Advanced Health Assessment (NUR504), Final Exam Preparation Questions & Answers-Which of the following is an example of subjective data that may be collected during a health assessment? a. Height and weight b. A patient's recall of his or her past health conditions c. Results from an abdominal CT scan d. Complete blood count - b. A patient's recall of his or her past health conditions 1. Which of the following is true regarding the data taken in a health history? a. Most health his...

Jurisprudence Exam Questions and Answers Already Passed Who can sign for controlled drug substances orders? Can they sign for more than 1 pharmacy? Full pharmacist Yes What are the requirements for dispensing without a prescription in a state of emergency situation? 1. Record of the date, name & address of patient, and the name, strength and quantity of drug dispensed 2. Communicate information to patient's prescriber asap Can a registrar waive pharmacy licensure requirements and issue a t...

Introduction to Radiologic and Imaging Sciences and Patient Care 7th Edition Adler Test Bank Chapter 01: Introduction to Imaging and Radiologic Sciences Adler: Introduction to Radiologic and Imaging Sciences and Patient Care, 7th Edition MULTIPLE CHOICE 1. The use of X-rays to create a medical image on patients is referred to as a. electrocardiography. b. radiography. c. sonography. d. magnetic resonance imaging. ANS: B Radiography is the making of records, known as radiographs...

OH Fire Alarm Study Materials Questions and Answers 100% Pass Smoke detectors installed in air duct systems are normally used to control spreading smoke. T/F ? True A two-wire Class B circuit has 10 smoke detectors on it. A Class B circuit will typically have an end-of-line device on the last detector in the circuit. The end-of-line device is usually a _____. Resistor A smoke detector installed in an air duct system is permitted to be used as a substitute for open area protection. ...