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CDRH To Start New Year By Expanding Alternative Summary Reporting

This article was originally published in The Gray Sheet

Executive Summary

Malfunction reports for ventilators and surgical staplers will be eligible for alternative summary reporting (ASR) in early 2001, FDA Center for Devices and Radiological Health officials predict.

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CDRH's compliance office is advising device firms to scrutinize seemingly routine service or maintenance requests, which may in fact be masking product malfunctions or problems warranting a recall

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