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FDA Variance Amendment from DePaul University Idea Realization Laboratory

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Summary

The Food and Drug Administration (FDA) has posted a variance amendment submitted by DePaul University's Idea Realization Laboratory. The document is available for review on the Regs.gov platform, with an associated attachment from the Center for Devices and Radiological Health (CDRH).

What changed

The FDA has made available a variance amendment submitted by DePaul University's Idea Realization Laboratory. This filing, associated with CDRH, indicates a specific request or modification related to regulatory requirements, though the exact nature of the variance is not detailed in the provided metadata. The document is listed under docket number FDA-2026-V-1761-0003.

Compliance officers should note that while this is a variance amendment, the lack of available content and specific details means immediate action is likely not required unless directly involved with DePaul University's Idea Realization Laboratory or related research. Further review of the attached PDF is recommended for a complete understanding of the amendment's scope and implications.

Source document (simplified)

Content

There are no documents available to view or download

Attachments 1

Variance Amendment 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-1761-0003
Docket
FDA-2026-V-1761-0003

Who this affects

Applies to
Educational institutions Medical device makers
Industry sector
3345 Medical Device Manufacturing 6111 Higher Education
Activity scope
Research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Medical Devices Research

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