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Internet registration and listing

This article was originally published in The Gray Sheet

Executive Summary

Evaluation of the Phase II pilot of the Center for Devices and Radiological Health Internet interface for meeting establishment registration and device listing requirements is posted May 1. Nine device firms participated in testing the R&L pilot (www.fda.gov/cdrh/registration/regpiloteval.html). The center is developing a proposed rule for implementation of electronic R&L. Once the data elements have been finalized, staffers will design the official interface, FDA says

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