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Month: October 2023

FDA Releases “Predetermined Change Control Plans for Machine Learning – Enabled Medical Devices: Guiding Principles”

On October 24, 2023, the FDA, Health Canada and the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) jointly publishing the “Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles.” This new publication is intended to lay the foundation for PCCPs for Machine Learning-Enabled Medical Devices and encourage international harmonization.

ANSI/AAMI ST98: A Guideline for Cleaning Validations of Reusable Devices

The new ANSI/AAMI ST98 standard, published in 2022, is a long awaited clarification of the strategy for cleaning validations for reusable medical devices. The standard serves as a key regulatory guideline to support device manufacturers in their regulatory submissions.

FDA Updates the Recognized Consensus Standards Database with New Sterilization Documents

At the end of July 2023, the United States Food and Drug Administration (FDA) issued a release indicating that they have recognized the following sterilization standard and Technical Information Reports (TIRs) to help advance innovation in medical device sterilization processes.