It 510 - Study guides, Class notes & Summaries

BIT 510 Midterm questions and answers verified 2024

TEA process - 21 CFR 330-14 add established ingredient to existing OTC monograph Request for Designation (RFD) - ask FDA if it is a drug, biological, device, combo HDE humanitarian device excempt - no effectiveness data required misbranded device - not cleared through 510k process (but needs one) adultered device - does not have PMA but needs one design input for device - requirements that must be met IDE (Investigational Device Exemption) - report within 5 working days: emergencies, use ...

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...

Ground (515 pg. 26) What does the symbol shown below represent? 3 (555 pg. 26) How many turns of safety rope must remain on the safety drum after a rated load and rated speed test of a winding drum operated safety? rail jack bolts (555 pg. 16) Proper adjustment of which of the following can reduce the effects of building compression on an elevator installation? Liquidtight Flexible Metal Conduit (505 pg. 6) What type of flex would be used to pipe a switch in a wet locati...

FINAL PROJECT MILESTONE THREE: SYSTEM REQUIREMENTS 2 URCovered, Inc., one of the largest major auto insurance companies in North America, is on the way to develop a mobile application to improve customer service in the area of claim management which will be an extension of the current web based claim management system. The development of this mobile application project needs a system requirements model which includes a requirements model, a data process model, a data flow diagram, a data d...

Device RAC Exam Questions & Answers With Accurate Explanations 2023 Which division has primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP - ANS-C. CDRH In this combination of a device and a drug, the primary mode of action is that of the vascular graft (device). The antibiotic is supportive in this case. A company wants to modify its legally marketed device such that the modification does not affect the inte...

RAC Prep Medical Devices Exam Prep 2024 with complete solution device - Answer ️️ -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 prima...

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...

Well-structured OPM1501 Assignment 3 (ANSWERS) 2024 - DISTINCTION GUARANTEED. (DETAILED ANSWERS - DISTINCTION GUARANTEED!). .... Question 1 1.1. Complete the following function machines so that the inputs give the correct outputs: a) 32 224 (3) b) 1080 − 960 (3) c) 525 25 (3) d) 510 270 (3) (12) 1.2. If you were asked to complete the following number line by filling in the missing numbers, explain why it would not be possible to do so: 19 31 42 (4) 1.3. Provide two ways you c...

OSHA 510 Exam Study Guide 253 Questions with Complete Solutions An example of incident Cost would be? - Correct Answers Overtime worked to keep on schedule due to accident Protect the safety and health of America's workers is the mission of what the government agrees - Correct Answers OSHA The General duty clause states that it is the employers responsibility to provide a workspace free from - Correct Answers recognized hazards To ensure consistent enforcement OSHA has set up? - Corre...