It 510 Study guides, Class notes & Summaries

GCP of Devices Exam Study Guide with Complete Solutions 510(k) Clearance - Correct Answer A 510(k) clearance or premarket notification [(510(k)] submission is a route the FDA uses to approve a medical device. If the FDA agrees the new device is substantially equivalent to a legally marketed device for which a premarket approval (PMA) is not required, the manufacturer may market it immediately. Humanitarian Device Exemption (HDE) Holder - Correct Answer The HDE Holder is the entity that obtai...

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 1 Latest 2024 with complete solution 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 Est...

RAC Glossary 2023 Review Update 21st Century Act - ANS-Amends FD&C Act and PHS Act to include provisions for: patient focused drug development, advancing new drug therapies, modern trial design and evidence development, patient access to therapies and information, antimicrobial innovation and stewardship, medical device innovations, improving FDA expertise and outreach, medical countermeasures innovation, vaccine access, certainty and innovation. 30-Day hold - ANS-Time period between f...

RAC Prep Medical Devices Latest Update Graded A 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 Exempt device Exempt from 510...

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 Prep Medical Devices Practice Test 2024. device - CORRECT 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 primary purpose Exe...

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 primary purpose Exempt device - ANSWER-Exempt from 510(k) if: -Diagnostic de...

HCB Corpsman 2024 Shipboard Exam Questions and Answers. CDC (Center for Disease Control) Federal agency for the investigation, identification, prevention and control of disease. Gait A matter of walking or moving on foot How many types of gait Six Navmed 6550/8 Medication Administration Record (MAR) NAVMED 6550/12 patient profile Sf 508 Doctor's Orders Sf 509 Doctor's Progress Notes Sf 510 Nursing Notes To add an entry that was laid or forgotten while riding a nursing note :...

DEVICE RAC EXAM - Questions and Answers (Complete Solutions) Which division would have primary jurisdiction over a vascular graft with an antibiotic based on primary mode of action? A. CDER B. CBER C. CDRH D. OCP A company wants to modify its legally marketed device such that the modification does not affect the intended use or alter the fundamental scientific technology of the device. If the design outputs of the modified device meet the design input requirements, this change would be best fil...