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Eric Henry
Insights 14 results
Article · Source: Journal of Health Care Compliance
May 1, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
Client Alert
January 10, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions
Client Alert
December 13, 2024
FDA Publishes Final Predetermined Change Control Plan Guidance for AI-Enabled Device Software Functions
Client Alert
August 23, 2024
Predetermined Change Control Plans (PCCPs) for Medical Devices: FDA Issues Draft Guidance
Article · Source: Medtech Insight Citeline Commercial
June 6, 2024
The Sky Is Not Falling – There's Time To Prep for Quality Management System Regulation's Launch
Client Alert
April 30, 2024
LDT Final Rule: Shifting the LDT Battlefield
Client Alert
March 25, 2024
FDA Publishes White Paper on Artificial Intelligence & Medical Products
Client Alert
February 8, 2024
FDA Aligns U.S. Medical Device Quality System Regulation with International Standards
Client Alert
October 11, 2023
FDA Finalizes Premarket Cybersecurity Guidance for Medical Devices
Client Alert
June 28, 2023
FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions
Client Alert
April 6, 2023
FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped?
Client Alert
December 19, 2022
FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance