United States: FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions - Morrison & Foerster LLP

Mondaq

10 May 2023 0 shares 1 views

United States: FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions - Morrison & Foerster LLP

Mondaq

Published 10 May 2023

On April 3, 2023, FDA released the draft guidance titled "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions"...

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United States: Federal Government Provides Further Guidance And Draft Attestation Form For Software It Acquires - Morrison & Foerster LLP

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United States: FDA Issues Draft Guidance For Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions - Goodwin Procter LLP

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United States: FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions - Morrison & Foerster LLP

United States: FDA Publishes Draft Guidance For Predetermined Change Control Plan For AI/ML-Enabled Device Software Functions - Morrison & Foerster LLP

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