Regulatory Affairs

Office of the Vice President and Innovation

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Recently Posted FDA Guidance Documents

12/20/2019 – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided […]

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