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
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