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Understanding the ISO 18562:2024 Standards Update for Medical Devices

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.

ACS Releases Review of Chemical Characterization Practices for Medical Devices on Behalf of FDA

On February 17, 2022, the American Chemical Society released a publication on behalf of the U.S. Food and Drug Administration (FDA) describing the current state and opinion of the FDA regarding chemical characterization processes and ways in which to improve them. In particular, the FDA’s response is intended to examine specific topics to promote continuous discussion regarding the disparities between where the industry currently stands and how alignment and proper development may occur.    

FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin

On October 15, 2020, the U.S. Federal Food and Drug Administration (FDA) released a new draft guidance, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin,” which is intended to add or supersede applicable sections of the 2016 biocompatibility guidance (recently updated in 2020), “Biological Evaluation of Medical Devices-Part 1: Evaluation and … Continued