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FDA issued a draft guidance that identifies the software information generally necessary for evaluating the safety and effectiveness of a device in a premarket submission.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 [...]

US: FDA Releases Artificial Intelligence/Machine Learning Action Plan

2024-02-29T17:06:58+00:00January 19th, 2021|Categories: Compliance, Innovation, Software, USA|Tags: , , , , , , , |

The FDA has released an action plan to develop a regulatory framework on artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD). The FDA aims to publish the draft guidance this year. As a Digital Research Organization, Meditrial [...]

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