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US FDA proposes tightening of declarations of conformity to consensus standard

This article was originally published in Clinica

Executive Summary

The US FDA will no longer allow companies to make a “declaration of conformity” to a voluntary medical-device consensus standard if the firm deviates from an FDA-recognized standard, according to a draft guidance issued May 12. The agency also plans to not allow companies to promise future conformance to a consensus standard to satisfy part of its premarket submission requirements.

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