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Month: April 2024

Understanding the ISO 18562:2024 Standards Update for Medical Devices

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The updated ISO 18562 standards, released in March 2024, now cover medical respiratory PPE like surgical masks and introduce new terms that could change testing requirements for medical devices. They emphasize the importance of considering a device’s aging and life cycle, as well as providing detailed breathing volumes for expanded patient populations. These changes aim to enhance safety evaluations for devices throughout their use, presenting manufacturers with new challenges.

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

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The FDA’s updated guidance on race and ethnicity data collection in clinical trials calls for using OMB-standardized categories to ensure accurate demographic representation. Sponsors must create a Diversity Action Plan, with mandatory implementation for new studies within 180 days after final guidance. Participants will self-report race and ethnicity, with the option to identify as multiracial and confirm their information against medical records.

Medical Device Software: Considerations for Device and Risk Characterization

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On February 2, 2024, the IMDRF released a draft guidance for public comment on Software as a Medical Device (SaMD). This document aims to unify global regulations by detailing device characterization and risk assessment for medical software. It seeks to create a shared understanding that can navigate the varied regulatory landscapes, promoting safer digital health solutions. Public feedback is encouraged to refine these critical guidelines.