From Wikipedia,
the free encyclopedia
An Investigational Device
Exemption (IDE) allows the
investigational device to be used
in a clinical study in order to
collect safety and effectiveness
data required to support a
Premarket Approval (PMA)
application or a
Premarket Notification
[510(k)] submission to
FDA. Clinical studies are most
often conducted to support a PMA.
Only a small percentage of
510(k)'s require clinical data to
support the application.
Investigational use also includes
clinical evaluation of certain
modifications or new intended uses
of legally marketed devices. All
clinical evaluations of
investigational devices, unless
exempt, must have an approved IDE
before the study is initiated.
Clinical evaluation of devices
that have not been cleared for
marketing requires:
- an IDE approved by an
institutional review board (IRB).
If the study involves a
significant risk device, the IDE
must also be approved by FDA
- informed consent from all
patients
- labeling for investigational
use only
- monitoring of the study and
- required records and reports
An approved IDE permits a
device to be shipped lawfully for
the purpose of conducting
investigations of the device
without complying with other
requirements of the
Food, Drug, and Cosmetic Act
that would apply to devices in
commercial distribution. Sponsors
need not submit a PMA or Premarket
Notification, register their
establishment, or list the device
while the device is under
investigation. Sponsors of IDE's
are also exempt from the Quality
System (QS) Regulation except for
the requirements for design
control.
A
sponsor of a significant risk
device study must submit a
complete IDE application to FDA.
There are no preprinted forms for
an IDE application; however, an
IDE application must include
certain required information. The
sponsor must demonstrate in the
application that there is reason
to believe that the risks to human
subjects from the proposed
investigation are outweighed by
the anticipated benefits to
subjects and the importance of the
knowledge to be gained, that the
investigation is scientifically
sound, and that there is reason to
believe that the device as
proposed for use will be
effective.
