RAC Prep Medical Devices 2023 LATEST UPDATE RATED A+

RAC Prep Medical Devices Study online at 1. 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 2. Exempt device: Exempt from 510(k) if: -Diagnostic device that was in distribution before 28MAY76, not a transitional device -is noninvasive -does not introduce energy into subject -not used for diagnosis without confirmation from another procedure More than 800 generic class I devices and 60 class II devices (documented in 21CFR 862-892) -Does not require clinical trials -Also may be exempt from GMPs (noted in regulation) 3. Devices used for collecting, processing, storing and administering blood products: Approved by CBER as devices (510(k) or PMA) 4. finished device: any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized 5. software: considered a device when used for a medical purpose without being part of a device's hardware 6. mobile medical app: considered a device when it meets the definition of a device 7. accessory: may be used with multiple parent devices or has unique stand-alone functions 8. class I device: General controls to ensure safety & effectiveness. -Low-risk device requiring -Usually exempt from 510k (93%) and QSR -Examples include exam gloves, hospital beds, lab equipment, surgical instruments, bandages 9. Class II device: General and special controls to ensure safety and effectiveness. -Requires 510(k) unless exempted (8%); may require clinical trials. -Examples include blood glucose test systems and infusion pumps, catheters, blood pressure cuff, ELISAs 10. Class III device: Requires general controls, special controls and premarket approval (PMA); -includes devices that are life-sustaining, life-supporting or pose significant potential