Artificial Intelligence, Food and Drug Administration (FDA), 510(k) RTA

FDA Issues Guidance on AI for Medical Devices

Ballard Spahr LLP on 8/22/2025

The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

King & Spalding on 8/26/2024

On August 22, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled, Predetermined Change Control Plans for Medical Devices. The draft guidance describes how FDA plans to implement new...more

Unpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents

Epstein Becker & Green on 7/11/2023

This post explores how bias can creep into word embeddings like word2vec, and I thought it might make it more fun (for me, at least) if I analyze a model trained on what you, my readers (all three of you), might have written....more

FDA Clears Sonic DL™ for Cardiac MRI Scans

Knobbe Martens on 6/13/2023

On June 5, 2023, GE HealthCare announced the FDA 510(k) clearance of Sonic DL™. GE HealthCare reports that Sonic DL™ is a deep learning-based technology intended to capture cardiac MRI images within a single heartbeat....more

FDA Reduces Regulatory Burden for Certain Medical Image Analyzers

Wilson Sonsini Goodrich & Rosati on 2/3/2020

The U.S. Food and Drug Administration (FDA) had regulated medical image analyzers for more than 20 years under the agency’s most stringent regulatory requirements. But the agency recently reclassified a subset of these device...more

Artificial Intelligence › Food and Drug Administration (FDA) › 510(k) RTA

FDA Issues Guidance on AI for Medical Devices

Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance

Unpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents

FDA Clears Sonic DL™ for Cardiac MRI Scans

FDA Reduces Regulatory Burden for Certain Medical Image Analyzers

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