FDA Draft Guidance - Accredited Labs - Submission Packages

The FDA Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA's requirements. The guidance advises importers how to use accredited -- rather than non-accredited -- laboratories and makes recommendations about the quality and type of test data and information that these laboratories should produce in support of test results submitted to the FDA. The draft guidance is also intended to reduce the likelihood that an importer will select only favorable test results to submit to the FDA. This draft guidance supports the FDA's import strategy emphasizing prevention of harm, intervention when risks are identified, and rapid response after harm has occurred. 

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