The FDA issued draft guidance to introduce De Novo request submitters to the current resources and associated content developed and made available to support medical device De Novo electronic submissions to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). Once finalized, this guidance will provide further standards for the medical device electronic format submission, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements.
Download the full guidance document here.