FDA Compliance

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FDA’s Regulation of AI/ML SaMD

Published: September 25, 2024

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Comparing US FDA vs EU MDR Medical Device Software Requirements

Published: August 13, 2024

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FDA Releases “Transparency of Machine Learning – Enabled Medical Devices: Guiding Principles”

Published: June 26, 2024

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An In-Depth Exploration of Reimbursement Billing Guides and Their Benefits

Published: June 12, 2024

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Preclinical Studies for Dental Bone Graft Devices – 510(k) Submissions

Published: May 29, 2024

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Collection of Race and Ethnicity Data in Clinical Studies – Standardizing the Sociocultural Construct of Our Society

Published: April 10, 2024

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Will Vaporized Hydrogen Peroxide (VHP) Sterilization for Medical Devices Become More Common?

Published: March 20, 2024

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Industry Update: Quality Management System Regulation (QMSR)

Published: March 6, 2024

ASCA Accreditation: FDA Annual Report and NAMSA Customer Experience

Published: February 29, 2024

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Embracing Digital Health Technologies: FDA’s New Guidance for Clinical Trials

Published: February 6, 2024

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

Published: October 30, 2023

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FDA Updates the Recognized Consensus Standards Database with New Sterilization Documents

Published: October 2, 2023

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FDA Publishes Updated Guidance for Breakthrough Devices Program

Published: September 21, 2023

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FDA Announces Three New Guidances Dedicated to 510(k) Submissions

Published: September 18, 2023

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Mechanical Hemolysis Assay for Blood Contacting Devices

Published: September 6, 2023

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FDA Publishes Notice of Modifications to the Recognized Consensus Standards for Medical Devices

Published: August 15, 2023

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