RAC Prep Medical Devices 2024 | 70 Questions with 100% Correct Answers | Verified | Latest Update 2024 | 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, mitigatio n, 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(k) if: -Diagnosti c 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 d evices (documented in 21CFR 862 -892) -Does not require clinical trials -Also may be exempt from GMPs (noted in regulation) Devices used for collecting, processing, storing and administering blood products - ✔✔Approved by CBER as devices (510(k) or PMA) 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 software - ✔✔considered a device when used for a medical purpose without being part of a de vice's hardware mobile medical app - ✔✔considered a device when it meets the definition of a device accessory - ✔✔may be used with multiple parent devices or has unique stand -
alone functions class I device - ✔✔General controls to ensure safety & effecti veness. -Low-risk device requiring -Usually exempt from 510k (93%) and QSR -Examples include exam gloves, hospital beds, lab equipment, surgical instruments, bandages Class II device - ✔✔General and special controls to ensure safety and effectiveness. -Requires 510(k) unless exempted (8%); may require clinical trials.
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