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Registration And Listing Data Submission 30-Day Time Limit Likely To Be Kept

This article was originally published in The Gray Sheet

Executive Summary

FDA likely will retain the current 30-day timeframe in which device manufacturers are required to submit registration and listing data to the agency following commencement of commercial operations, as the device center moves forward with its plans to revamp its registration and listing program.

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Registration and listing reengineering

Stakeholder meetings to be held in Dallas, Texas and Irvine, California on Sept. 19 and 20, respectively, will discuss FDA's proposal to require device registration and listing via the Internet, an Aug. 16 Federal Register notice announces. In addition to changes in the timelines for registration and listing (1"The Gray Sheet" May 31, 1999, p. 5), FDA is considering "streamlining the collection of [medical device reporting] baseline information" through the device listing process

Registration and listing reengineering

Stakeholder meetings to be held in Dallas, Texas and Irvine, California on Sept. 19 and 20, respectively, will discuss FDA's proposal to require device registration and listing via the Internet, an Aug. 16 Federal Register notice announces. In addition to changes in the timelines for registration and listing (1"The Gray Sheet" May 31, 1999, p. 5), FDA is considering "streamlining the collection of [medical device reporting] baseline information" through the device listing process

FDA Delaying Inception Of Internet Registration And Listing Pilot

FDA's pilot program to test the submission of registration and listing information by manufacturers via the Internet has been delayed until early 2000, agency staffers report.

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