Obtaining an FDA Investigational Device Exemption - Webinar By GlobalCompliancePanel by globalcompliancepane


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                                                                        RAPS Approved Webinar on

Obtaining an FDA Investigational Device Exemption

Date: Tuesday, November 20, 2012                                       Time: 10:00 AM PST | 01:00 PM EST

Course "Obtaining an FDA Investigational Device         Duration:              60 Minutes
Exemption" has been pre-approved by RAPS as
                                                        Instructor:            Robert F. Munzner
eligible for up to 1.00 credits towards a participant's
RAC recertification upon full completion.               Location:              Online

                        Robert F. Munzner
                        Medical Device                                     Register Now

Robert Munzner was employed in the FDA Office of Device Evaluation for more than twenty years. As Chief
of the Neurological Devices Branch he reviewed and supervised the review of IDE, PMA and 510(k)
applications. He also served as Acting Director of the Division of Anesthesiology, Neurology, and Radiology
Devices. ...more

Clinical testing and studies of effectiveness are often needed to demonstrate that new medical
devices are reasonably safe and effective. The participation of human subjects in these studies
often implies some degree of risk and outcomes which are necessarily unpredictable. It is essential,
therefore, that the rights, safety, and welfare of the subjects be protected. The instrument by
which this is accomplished is the Investigational Device Exemption (IDE).

We will discuss here the conditions under which this protection is necessary, the means by which
the IDE rules can be met while considering the degree of risk involved, and the means by which an
approved IDE can be obtained.

Areas Covered in the Session:

    l   Definition of "Medical Device"
    l   Meaning of "Intended Use"
    l   "Research" vs. " Treatment
    l   Institutional Review Boards
    l   21 CFR 812
    l   An IDE Without an FDA Application
    l   The Sponsor - Investigator Relationship
    l   Contents of an Application for an IDE
    l   The Investigational Plan
    l   Device "labeling" defined, required
    l   Informed Consent Requirements
    l   Laboratory Data
    l   Time Frame for FDA Response

Who Will Benefit:
                                          Suggest a Topic
    l   Medical device developers
    l   Physicians conducting              More Webinars
    l   Hospital Administrators
    l   Biomedical Engineers
    l   Biomedical Engineering
        department chairs                  Click here to
    l   Students doing human             register for this
        research                              webinar

It would be really nice if you can circulate this mail to all your deserving colleagues who can
immensely benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,

About GlobalCompliancePanel
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