2025) comprehensive questions and
verified answers (Detailed &
Elaborated) ACTUAL EXAM 2025
TEST 100% Solved 2025!!
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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
, 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
Exempt device
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 Approved by CBER as devices (510(k)
collecting, or PMA)
processing,
storing and
administering
blood products
any device or accessory to any device
that is suitable for use or capable of
finished device
functioning, whether or not it is
packaged, labeled, or sterilized
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
, 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
Exempt device
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 Approved by CBER as devices (510(k)
collecting, or PMA)
processing,
storing and
administering
blood products
any device or accessory to any device
that is suitable for use or capable of
finished device
functioning, whether or not it is
packaged, labeled, or sterilized
