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Go to IMDRF first, industry tells FDA on plans to standardize GCP for foreign device trials

This article was originally published in SRA

Executive Summary

Efforts by the US Food and Drug Administration to standardize good clinical practice requirements for certain foreign medical device trials have been termed as "premature" by the medtech industry. Device companies believe that the FDA should first collaborate with the International Medical Device Regulators Forum to develop harmonized guidance on this topic instead of straightaway changing its rules on acceptance of data from foreign device trials1-4.

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