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FDA ready to test international device submission form

This article was originally published in Clinica

Executive Summary

US FDA is preparing to test the feasibility of adopting a single standard premarket submission form that could be used in every market of the world. The agency announced last week that it will launch a one-year pilot programme to assess the internationally harmonised format and content developed by Study Group 1 (SG1) of the Global Harmonization Task Force (GHTF).

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