Transcript Device Decision Tree

Device Review Decision Tree
Version Date: 3-5-12
Does this study involve the clinical investigation to determine the
safety and effectiveness of a device?
( e.g. – Are you evaluating the device for safety and efficacy? )
No: FDA Regs
DO NOT apply
Yes: FDA Regs apply
Is study exempt from IDE Regulations ?
Answer NO if an In-vitro diagnostic device.
Is the device a Research Use
Only Device (RUO)?
No
Yes
NO
Yes
Does the device being used have FDA
approval for any indication?
Will results be
used to diagnose
or treat subjects?
Yes
Do all other procedures fit
under an expedited criteria
NO
No
Do all other procedures fit
under an expedited criteria?
Category # 9: Continuing review of research,
not conducted under an investigational new
drug application or investigational device
exemption where categories (2) through (8)
do not apply but the IRB has determined and
documented at a convened full IRB meeting
that the research involves no greater than
minimal risk and no additional risks have
been identified.
Will other procedures
require study to be reviewed
by full board?
(e.g all procedures do not fit
under expedited criteria or
study is not minimal risk )
Is study minimal risk?
NO
NOTE: FB does NOT determine SR/NSR
status but may determine if protocol is
minimal risk, therefore allowing future
continuations to be expedited via category #
9.
No
Yes
YES
To Full Board for Review. As expedited
criteria # 4 not applicable. DO NOT use
Expedited Criteria # 1 as the device is not
being evaluated therefore FDA regulations
do not apply.
Is the device an in-vitro diagnostic
device?
Yes
No
Yes
NO
Yes
Is study minimal risk?
Yes
Expedite under
category # 4
and any other
applicable
categories.
(RUO devices
not considered
a medical
device.)
NO
To Full Board
for Review
NOTE: FB does
NOT determine
SR/NSR status
Expedite
under
category # 1
No
Send full
protocol to
IRB for review.
Send study to SOM
CTO for IDE opinion
and to full board to
make SR/NSR
Determination.
NSR
Study Involves Device: Overall Summary
Use only/No evaluation of device: FDA
regulations do NOT apply: expedited via
category # 4
Evaluation of Device- FDA regulations DO
apply- If device exempt from IDE regulations
or NSR and protocol may otherwise be
reviewed by expedited review procedures
expedite via category # 1.
Full Board
determines study
is NSR- Expedite
review of
protocol under
cat# 1.
Yes
Send protocol to
SOM CTO for IDE
opinion and to full
board for review
and SR/NSR
Determination
SR
Full Board
determines study
is SR: Full Board
to review
protocol .
DO NOT expedite
review of
protocol.