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Ask the Engineer

Reusable Medical Devices

By Trabue D. Bryans
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Will FDA accept reprocessing instructions from a predicate device? What do proposed guidelines say about the requirement of multiple markers to properly demonstrate cleaning efficacy? This week’s Ask the Engineer covers some frequently asked questions on this topic.

Will FDA accept reprocessing instructions from a predicate device? What do proposed guidelines say about the requirement of multiple markers to properly demonstrate cleaning efficacy? This week’s Ask the Engineer covers some frequently asked questions on this topic.

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