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Month: October 2023

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

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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

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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

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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.