Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and FDA Staff

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Electronic Submission Template for Investigational Device Exemption (IDE) Applications." FDA is issuing this draft guidance for sponsors submitting IDE applications to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). It introduces those sponsors to the current publicly available resources and associated content developed to support IDE electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for sponsors to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.