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FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility

 
• By Brian Bossetta

The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.

Chemistry Lab
• Source: Shutterstock

The Center for Devices and Radiological Health is offering a new dataset its director, Jeff Shuren, says is part of the center’s ongoing commitment to reduce the burden of premarket processes, while increasing the consistency and transparency of biocompatibility methods.

In the agency’s announcement, Shuren further states the new data “will allow analytical chemistry labs to determine their ability to detect a broad range of potential chemicals" that might...

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Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
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