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510(K) SUMMARY/STATEMENT FINAL RULE PROTECTS TRADE SECRET DATA FROM PUBLIC DISCLOSURE; ACCURACY CERTIFICATION REQUIREMENTS CLARIFIED BY FDA

This article was originally published in The Gray Sheet

Executive Summary

Provisions in FDA's final rule on 510(k) premarket notification summaries and 510(k) statements will give manufacturers protection from the release of confidential information, particularly data on the technological characteristics of a product. The rule, published in the Dec. 14 Federal Register, states that FDA "does not intend that [510(k)] submitters include trade secret or confidential commercial information in the 510(k) summaries, which Congress expressly intended for public disclosure."
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