Division of Clinical Research

Office of the Vice President and Innovation

Category results for: premarket submissions

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┬áthis document┬áto describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided […]

Dental Devices Premarket Submissions (Free FDA Webinar)

Summary: On Wednesday, October 2, 2019, the FDA will host a webinar to discuss and answer questions from industry about preparing premarket submissions for dental devices. Background: A manufacturer who intends to market a dental device should conform to the regulatory controls in the Federal Food, Drug, and Cosmetic Act and the premarket notifications requirements described in Title […]

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