FDA Says Some Notice-To-Industry Letters Will Be Level 1 Guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA says some of its new "notice-to-industry" letters will have the same force as agency guidance documents that take effect immediately.
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Device makers see benefit in FDA’s plan to issue “notice to industry” letters when it wants to communicate policy changes quickly, but industry reps emphasize that FDA should not overuse the approach.