Content of Premarket Submission for Device Software Functions

2023-03-29T15:49:17+00:00November 4th, 2021|Categories: Various|Tags: , , , , , , , , , , |

FDA issued a draft guidance that identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission. This document is intended to cover: ▪️ firmware and other means for software-based control of medical [...]