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510(k) SUMMARY DATA AVAILABILITY ON INTERNET SLATED FOR MAY IN FDA EFFORT TO REDUCE FOI BACKLOG; PMA, MDR DATA ALSO TO BE POSTED ON CDRH "HOMEPAGE"

This article was originally published in The Gray Sheet

Executive Summary

Summaries of safety and effectiveness data for 510(k)-cleared devices are slated to be made available on the Internet in about three months, according to FDA staffers. Such a development would allow parties that normally have to obtain device summaries through the often lengthy Freedom of Information Act procedures to get the data more rapidly via computer.
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