Quiz 13: Devices BTEC 2322 (BTEC2322) Introduction to Biopython - UH | questions and answers latest SP 26.

BTEC2322 Quiz13_Device_sp26 Due Apr 23 at 11:59pm Points 15 Questions 15 Available Apr 21 at 1pm - Apr 23 at 11:59pm Time Limit 60 Minutes Instructions This quiz was locked Apr 23 at 11:59pm. Attempt History Attempt Time Score LATEST Attempt 1 23 minutes 13 out of 15 Score for this quiz: 13 out of 15 Submitted Apr 23 at 1:36pm This attempt took 23 minutes. Correct answer  Question 1 1 / 1 pts Devices do not achieve their primary intended purposes through chemical action within or on the body Medical devices include diagnostic tests and instruments Most devices exert their therapeutic effects systemically Devices do not have to be metabolized to achieve their intended purposes Devices are intended for use in the diagnosis, cure, mitigation, prevention or treatment of disease Wrong answer  Question 2 0 / 1 pts Exam 3 on Tuesday next week, May 28. Third exam pointers S ( What does not apply to medical devices: Devices include invasive and non-invasive medical products. Which of these FDA-regulated medical devices is not found in slide #5?Dental Floss Bandages Pregnancy test kit Electric toothbrush Gloves Correct answer  Question 3 1 / 1 pts A contraceptive device that promoted migration of bacteria and infection of the ovaries and uterus An exploding vaping device An strong X-ray that caused mutations and deformities in fetuses (feti?) An artificial heart that was contaminated with tetanus toxin A not-so-hip replacement that led to frequent dislocations Correct answer  Question 4 1 / 1 pts 510k is also known as pre-marketing approval 510k is more of a marketing clearance rather than an approval Required when significant changes have been made to a device previously cleared through 510k 510k is normally submitted to FDA 90 days prior to marketing a device Purpose is to demonstrate that a new device is substantially equivalent to a marketed device that was previously cleared through a 510k process Correct answer  Question 5 1 / 1 pts microscope Brain Stimulator For Epilepsy insulin Dosing Device What crisis led to the passage of the Medical Device Regulation Act of 1976, a law that gave the FDA authority to regulate the safety and effectiveness of devices? What does not apply to a 510k for a medical device? Which of these devices poses minimal health risks to patients and is least likely to be classified as a Class III device? Use FDA's product classification tool to find the answer. defibrillator Correct answer  Question 6 1 / 1 pts Description of the device design Statistical analysis of data obtained from clinical testing of the device Sponsors role during the clinical trial Clinical study protocol Identification of investigators or trial sites Correct answer  Question 7 1 / 1 pts An approved IDE will allow approval of a device for the treatment or diagnosis of a rare disease even without effectiveness data. An approved IDE will allow an unapproved device to be used in clinical study to obtain data in support of a premarket approval application An approved IDE will allow an unapproved device to be used in clinical study to obtain data in support of a 510k submission IDE stands for Investigational Device Examination An approved IDE will allow an unapproved device to be used in clinical study to collect safety and effectiveness data Correct answer  Question 8 1 / 1 pts FALSE TRUE Correct answer  An Investigational Device Exemption allows an unapproved device to be tested in human subjects. The IDE submitted to FDA is not expected to contain: What does not apply to IDE? All marketed devices have been proven to be safe and effective in human clinical trials.Question 9 1 / 1 pts order denying approval approvable letter approval order refuse to file letter not approvable Correct answer  Question 10 1 / 1 pts The device on trial is a balloon that is inflated after insertion into an artery The Court's decision was based on a law stating that device makers can be sued even if devices passed FDA's safety requirements Manufacturers can still get sued for injury due to a defective device in Federal Courts The Supreme Court did not award Riegel, the injured party, for loss of income As a consequence of the defective medical device, Riegel had to be placed on life support and lost income Wrong answer  Question 11 0 / 1 pts QSR does not apply to the medical device research process QSR for medical devices is equivalent to cGMP for pharmaceuticals A QSR requirement is for Unique Device Identifier (UDI) in marketed devices to facilitate post-market surveillance QSR applies to development and manufacturing process for Class I devices QSRs are found in CFR21 Part 820 Correct answer  Question 12 1 / 1 pts Six months after CDRH accepts the filing of PMA application for a device, what type of letter will CDRH send the manufacturer if the application for the most part meets regulatory requirements but is lacking minor information that the manufacturer can easily provide? What does not apply to the Supreme Court case involving Riegel vs Medtronic? What does not apply to Quality systems regulations for medical devices? Starting at minute 39:50, the lecture video discusses which requirement of design controls?Design Planning, where the manufacturer must describe or reference the design and development activities and assign responsibilities for implementation. Ensuring that the individuals making critical decisions about a device's safety are qualified and that their roles are documented. Misbranding violation when a medical device requires a prescription but is sold over-the-counter instead Human factor as a discipline that focuses on device design variables that can affect the safe and effective use of a medical device by a patient or healthcare practitioner. Design Validation as the final stage of the development process that ensures the device actually meets the needs of the end user and works for its intended use in a real-world environment. Correct answer  Question 13 1 / 1 pts Management Design controls Production and process controls Records and Documents Corrective and Preventive Actions Correct answer  Question 14 1 / 1 pts TRUE FALSE Correct answer  Question 15 1 / 1 pts CDRH follows a seven system quality system inspection technique (QSIT) to assess a device manufacturers compliance with QSRs. Which is not one of the four major or foundation systems that are the main focus of CDRH inspections ? It is mandatory for patients, caregivers, and device manufacturers to report adverse events concerning the use of medical devices through FDA's Office of Regulatory Affairs web site. Advertising and promotion of approved medical devices normally do not require pre-clearance of the materials with the FDA. However, advertising of a device for a non-FDA approved use is illegal and isMisbranding Mail fraud Slick Joe Flick Adulteration Out-of-specifications Invalidated Quiz Score: 13 out of 15 considered: