On September 26, 2019, the FDA released a new draft guidance document titled “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.” This guidance was published in order to be compliant with the provision set in FDA Reauthorization Act of 2017, which amended the FD&C Act to clarify that any medical devices under 510(k), 513(f)(2)(A), 515(c), 515(d), 20 515(f), 520(g), 520(m),