The U.S. Food and Drug Administration (FDA) has drafted new guidance on the electronic submissions for medical devices with both bindings and nonbinding provisions intact. The drafted guidance is formed, keeping in mind, the specificity of the section 745A(b)(3), which was created by the FDA Reauthorization Act of 2017.
In the seven-page draft guidance, the FDA concludes in a warning that it is not feasible to implement and describe the electronic medium of submission for all the devices in just one draft guidance. The FDA further plans to implement the requirement of section 745A(b)(3) while the specific formats and submissions will be developed in individual guidance documents.