FDA is issuing this draft guidance document to introduces submitters of De Novo requests to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA.

This draft guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission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 industry to improve submission consistency and enhance efficiency in the review process.

When finalized, this guidance will provide further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.