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FDA issues supplementary SUDs (single use devices) rules:

This article was originally published in Clinica

Executive Summary

The US FDA has issued additional clarification of its rules controlling the reuse of single use devices. It said that manufacturers who reprocess their own single-use devices must disclose that fact to the agency. The company must also register with the FDA so inspectors know where the reprocessing is occurring and list what devices are being reprocessed, it said.

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