4/10/25, 12:59 PM RAC Prep Medical Devices 2025) comprehensive questions and verified answers (Detailed & Elaborated) ACTUAL EXAM 20…
RAC Prep Medical Devices 2025)
comprehensive questions and verified answers
(Detailed & Elaborated) ACTUAL EXAM 2025
TEST 100% Solved 2025!!
Save
Terms in this set (71)
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
device
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
https://quizlet.com/1029738141/rac-prep-medical-devices-2025-comprehensive-questions-and-verified-answers-detailed-elaborated-actual-exam… 1/15
, 4/10/25, 12:59 PM RAC Prep Medical Devices 2025) comprehensive questions and verified answers (Detailed & Elaborated) ACTUAL EXAM 20…
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
Exempt device 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 Approved by CBER as devices (510(k) or PMA)
collecting, processing,
storing and administering
blood products
any device or accessory to any device that is
finished device suitable for use or capable of functioning, whether
or not it is packaged, labeled, or sterilized
considered a device when used for a medical
software
purpose without being part of a device's hardware
considered a device when it meets the definition of
mobile medical app
a device
may be used with multiple parent devices or has
accessory
unique stand-alone functions
General controls to ensure safety & effectiveness.
-Low-risk device requiring
class I device -Usually exempt from 510k (93%) and QSR
-Examples include exam gloves, hospital beds, lab
equipment, surgical instruments, bandages
https://quizlet.com/1029738141/rac-prep-medical-devices-2025-comprehensive-questions-and-verified-answers-detailed-elaborated-actual-exam… 2/15
RAC Prep Medical Devices 2025)
comprehensive questions and verified answers
(Detailed & Elaborated) ACTUAL EXAM 2025
TEST 100% Solved 2025!!
Save
Terms in this set (71)
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
device
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
https://quizlet.com/1029738141/rac-prep-medical-devices-2025-comprehensive-questions-and-verified-answers-detailed-elaborated-actual-exam… 1/15
, 4/10/25, 12:59 PM RAC Prep Medical Devices 2025) comprehensive questions and verified answers (Detailed & Elaborated) ACTUAL EXAM 20…
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
Exempt device 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 Approved by CBER as devices (510(k) or PMA)
collecting, processing,
storing and administering
blood products
any device or accessory to any device that is
finished device suitable for use or capable of functioning, whether
or not it is packaged, labeled, or sterilized
considered a device when used for a medical
software
purpose without being part of a device's hardware
considered a device when it meets the definition of
mobile medical app
a device
may be used with multiple parent devices or has
accessory
unique stand-alone functions
General controls to ensure safety & effectiveness.
-Low-risk device requiring
class I device -Usually exempt from 510k (93%) and QSR
-Examples include exam gloves, hospital beds, lab
equipment, surgical instruments, bandages
https://quizlet.com/1029738141/rac-prep-medical-devices-2025-comprehensive-questions-and-verified-answers-detailed-elaborated-actual-exam… 2/15
