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FDA Variance Request from Laina Callow - Comment Period Closed

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Summary

The Food and Drug Administration (FDA) has closed the comment period for a variance request submitted by Laina Callow. The application, authored by CDRH, was available for public comment on regulations.gov.

Published by FDA on regulations.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

The FDA has closed the public comment period for a variance request submitted by Laina Callow. The application, associated with docket ID FDA-2026-V-1611-0001 and authored by the Center for Devices and Radiological Health (CDRH), was made available for review and comment on the regulations.gov platform.

As the comment period is closed, regulated entities should no longer submit feedback on this specific variance request. Further actions or decisions by the FDA regarding this application will be communicated through official channels. Compliance officers should note that this pertains to a specific variance request and may not represent a broader policy change.

Archived snapshot

Mar 27, 2026

GovPing 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.

Content

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Attachments 2

Variance Application from Laina Callow

Restricted: Personally Identifiable Information

More Information
- Author(s) CDRH

Variance Application from Laina Callow - Redacted

More Information
- Author(s) CDRH
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Last updated

Classification

Agency
FDA
Instrument
Consultation
Legal weight
Non-binding
Stage
Consultation
Change scope
Minor
Document ID
FDA-2026-V-1611-0001
Docket
FDA-2026-V-1611-0001

Who this affects

Applies to
Drug manufacturers Medical device makers
Industry sector
3254 Pharmaceutical Manufacturing 3345 Medical Device Manufacturing
Activity scope
Drug Labeling Medical Device Approval
Geographic scope
United States US

Taxonomy

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

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