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Validating Reuse: Single-Use Device Oversight Taxes FDA Workload

This article was originally published in The Gray Sheet

Executive Summary

AdvaMed is pressing FDA to review validation data for all reprocessed single-use devices

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Regulatory News In Brief

Calling MDUFMA stakeholders: Reauthorization and potential modification of the Medical Device User Fee and Modernization Act of 2002, which expires after fiscal year 2007, will be the focus of the third annual MDUFMA stakeholder meeting in Gaithersburg, Md. Nov. 17. Agenda items include the user fee structure, premarket review performance goals and the third-party inspection program. Attendees must register online by Oct. 28...

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