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发帖数: 25265 | 1 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 Food and Drug Administration (
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. |
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