The Evolution of Chemical Characterization for Medical Devices.

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Author: Sandi Schaible
Date: Apr. 2021
From: Medical Product Outsourcing(Vol. 19, Issue 3)
Publisher: Rodman Publishing
Document Type: Article
Length: 1,286 words
Lexile Measure: 1470L

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In recent years, medical device manufacturers have faced rapidly evolving expectations about conducting biocompatibility testing to support preclinical product safety testing. With the recent changes to ISO 10993, the evaluation of biological safety of devices is experiencing some of the most significant changes in history.

Regulators quickly adopted the publication of ISO 10993-1:2018 (Part 1) because it requires manufacturers to develop biological test strategies based on their devices' potential risks. With this new guidance, physical and chemical information should be the starting point for identifying device-specific risks.

Additionally, the number of devices that fall within reach of ISO 10993-1 and corresponding guidance documents has rapidly expanded. Teams still familiarizing themselves with these evaluation processes and regulatory expectations should take the time to understand the history of the methods at hand, the thought process that has advanced it, and how to apply this historical lens moving forward.

The Debut of Chemical Characterization

Manufacturers became accustomed to conducting a more standardized set of tests based on their device's contact type and duration before the revised ISO 10993-1 was released in 2018. Testing strategies specific to the device were not common, and oftentimes, the testing that could reveal unknown risks, such as the chemical characterization and risk assessment, was the final task left before product approval submission. This approach could, at times, leave manufacturers scrambling at the last moment to mitigate unanticipated risks.

During this period of time, the shift to identifying potentially harmful compounds earlier in the process was gaining traction with regulatory bodies. With the pathway to submission leaving little room for error, this new mindset often left sponsors with concerns they may not have planned to address.

The U.S. Food and Drug Administration (FDA) created a launchpad for revising the standard through its 2016 Draft Guidance on the Use of ISO 10993 Part 1. The guidance outlined the role of chemical characterization in the process and the importance of addressing it...

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Gale Document Number: GALE|A658473771