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Firms Must Submit The Good, Bad, And Ugly Trial Data On Devices Under Clinical Trials Rule

Executive Summary

Device firms will have to submit a lot more clinical trials outcomes data to the ClinicalTrials.gov portal – including for products that have not been cleared, approved, or launched – based on a final rule recently issued by HHS. Even though sponsors can delay reporting two years, the rule expands the volume of reports that will find their way to the public-facing, clinical trials website, and the change could have downsides, attorneys say.

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