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Obtaining an FDA Investigational Device Exemption - Webinar By GlobalCompliancePanel

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Obtaining an FDA Investigational Device Exemption - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                      Toll Free Number: 800-447-9407


                                                                        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
                        Consultant,

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


Overview:
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
        research
    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,
Event-coordinator
GlobalCompliancePanel

About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model
for online compliance training by creating a single window of learning opportunities for compliance
professionals & providing a forum for expert speakers/panelists to render their services through simplified
online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of
best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance
professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all
sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal
ensures a secure & cost effective online environment and also support your E-learning and development
on/through our website. Keep track of all webinars arranged for your industry through notifications & event
calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.


GlobalCompliancePanel
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801

Phone: 800-447-9407 or
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DOCUMENT INFO
Description: Overview: 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. Interpretation of the IDE rules requires a precise knowledge of the terminology used, such as "medical device," "intended use," "Institutional Review Board (IRB)," "sponsor," "investigator," and "informed consent." We will define these terms and explain how subtleties of the definitions affect the interpretation of the rules.