There are no
preprinted forms for an IDE application. However, the following information
must be included in an IDE application for a significant risk (SR) device
investigation. FDA and IRB approvals are required prior beginning a SR clinical
study.
Three
copies of a signed IDE application to FDA in the order provided (21 CFR
812.20):
1.
Name
and address of sponsor (sponsor/investigator)
2.
Report
of prior investigations (21 CFR812.27).
a.
A
bibliography of all publications
b.
Copies
of all published and unpublished adverse information
c.
Copies
of other significant publications if required by an IRB or FDA
d.
A
summary of all other unpublished information that is relevant to an evaluation
e.
If
there is nonclinical laboratory data, it should meet GLP requirements (21
CFR58).
3.
Investigational
plan (21 CFR 812.25) – in the following order:
a.
Purpose
The
name and intended use of the device and the objectives and duration of the
investigation
b.
Protocol
A
written protocol describing the methodology to be used and an analysis of the
protocol demonstrating its scientific soundness
c.
Risk
analysis
·
A
description and analysis of all increased risks to the research subjects and
how these risks will be minimized – a justification for the investigation
·
A
description of the patient population (number, age, sex and condition)
d.
Description
of this device
·
A
description of each important component, ingredient, property, and principle of
operation of the device
·
Any
anticipated changes in the device during the investigation
e.
Monitoring
procedures (submission of written monitoring procedures are not required for
studies sponsored by a sponsor-investigator where only one investigator is
involved in the study. Guidance on IDE Policies and Procedures, DHHS, 1998)
·
The
sponsor’s written procedures for monitoring the investigation
·
The
name and address of each monitor
f.
Additional
records and reports
1.
A
description of the methods, facilities, and controls used for the manufacture,
processing, packing, storage, and installation of the device
2.
Signed
investigators written agreement (ref. 21 CFR 812.43)
3.
Certification
that all investigators have signed the agreement (new investigators will sign
the agreement before being added to the study)
4.
A
list of the name, addresses, and chairpersons of all IRBs
5.
The
name and address of any institution other than those above
6.
The
amount, if any, charged for the device and explanation
7.
Copies
of all labeling for the device
8.
Copies
of all informed consent forms and information materials to be provided to
subjects (21 CFR 50)
9.
Any other relevant information (information
previously submitted to FDA in accordance with 21 CFR 812 may be incorporated
by reference
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