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Routine Notice Added Final

DePaul University Variance Application

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Summary

The FDA has posted a variance application submitted by DePaul University's Idea Realization Laboratory. The document is available for review on the Regs.gov platform. No specific compliance actions or deadlines are indicated for other entities.

What changed

The Food and Drug Administration (FDA) has made available a variance application submitted by DePaul University's Idea Realization Laboratory. This application, identified under docket number FDA-2026-V-1761-0001, pertains to a specific request for a variance, though the exact nature of the variance and its regulatory implications are not detailed in the provided information.

As this appears to be an informational posting of a submitted application, there are no immediate required actions or compliance deadlines for regulated entities. Compliance officers should note this filing for awareness, particularly if their organization operates within similar research or development contexts that might be affected by future FDA decisions related to this variance.

Source document (simplified)

Content

There are no documents available to view or download

Attachments 1

Variance Application from DePaul University, Idea Realization Laboratory

More Information
- Author(s) CDRH
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Classification

Agency
FDA
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
FDA-2026-V-1761-0001
Docket
FDA-2026-V-1761-0001

Who this affects

Applies to
Educational institutions Drug manufacturers Medical device makers
Industry sector
6111 Higher Education 3254 Pharmaceutical Manufacturing 3345 Medical Device Manufacturing
Activity scope
Regulatory Variance Applications
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11
Topics
Medical Devices Pharmaceuticals

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