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An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used 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). [2]
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(a) Application form. The applicant shall submit a completed and signed application form that contains the following: (1) The name and address of the applicant; the date of the application; the application number if previously issued (for example, if the
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Such forms can be opened using Word as well. Ability to use Microsoft SQL Server, Microsoft Office Access, or other databases as back-end data repository. Multiple views for the same forms, to expose different features to different class of users. Template Parts, used to group Office InfoPath controls for use later. Template parts retain its ...
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