FDA wants companies to edit 510(k)s for public disclosure
This article was originally published in Clinica
Executive Summary
Companies that seek to market their products via the 510(k) route in the US will soon face some additional paperwork. The FDA has proposed that manufacturers begin supplying the agency with a "redacted" copy of their 510(k) submission, ie a filing stripped of any trade secrets, confidential commercial information or patient identification.
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