RAC Prep Medical Devices Exam Updated 2023 Graded A+

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 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) Devices used for collecting, processing, storing and administering blood products - ANSWER-Approved by CBER as devices (510(k) or PMA) finished device - ANSWER-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 - ANSWER-considered a device when used for a medical purpose without being part of a device's hardware mobile medical app - ANSWER-considered a device when it meets the definition of a device accessory - ANSWER-may be used with multiple parent devices or has unique stand-alone functions class I device - ANSWER-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