CDRH Grants Variance to University of Texas at Austin
Summary
FDA CDRH issued a variance approval to The University of Texas at Austin on April 22, 2026, granting an exception to standard medical device regulatory requirements under the referenced variance proceeding. The variance allows UT Austin to conduct specified activities that would otherwise require separate FDA authorization under 21 CFR Part 812. The approval is documented under docket FDA-2026-V-3707 and is effective upon issuance.
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What changed
FDA CDRH has issued a variance approval to The University of Texas at Austin, granting an exception to standard requirements under the Federal Food, Drug, and Cosmetic Act and associated regulations governing medical device research and development. This variance specifically authorizes UT Austin to conduct the described device activities without requiring separate FDA approval for those activities.
Affected academic research institutions and medical device developers should note that CDRH variances are granted on a case-by-case basis and may establish precedent for similar requests. Entities conducting investigational device activities should review whether their programs align with variance conditions or require independent IDE submissions.
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Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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Variance Approval from FDA CDRH to The University of Texas at Austin
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