Rac Prep Medical Devices Exam Prep 2023

1 / 27RAC Prep Medical Devices Exam Prep 20231. 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 purpose2. 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 procedure2 / 27More 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 sterilized5. software: considered a device when used for a medical purpose without being part of a device's hardware6. mobile medical app: considered a device when it meets the definition of