Changeflow GovPing Healthcare FDA Variance Approval Letter to Kyle Cummings
Routine Notice Added Final

FDA Variance Approval Letter to Kyle Cummings

Favicon for www.regulations.gov Regs.gov: Food and Drug Administration
Published March 20th, 2026
Detected March 21st, 2026
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Summary

The FDA has issued a variance approval letter to Kyle Cummings, as posted on March 20, 2026. The document is restricted due to personally identifiable information and was authored by CDRH.

What changed

The Food and Drug Administration (FDA) has issued a variance approval letter to an individual named Kyle Cummings. The document, posted on March 20, 2026, is designated as restricted due to the presence of personally identifiable information. The Center for Devices and Radiological Health (CDRH) is listed as the author.

This notice serves as an official record of the FDA's decision regarding a variance request. While the specific nature of the variance and its implications are not detailed due to redactions, regulated entities, particularly drug and medical device manufacturers, should be aware of such approvals as they may set precedents or indicate specific pathways for regulatory compliance. No immediate actions are required for general compliance officers, but awareness of this approval is noted.

Source document (simplified)

Content

There are no documents available to view or download

Attachments 2

Variance Approval Letter to Kyle Cummings

Restricted: Personally Identifiable Information

More Information
- Author(s) CDRH

Variance Approval Letter to Kyle Cummings_Redacted

More Information
- Author(s) CDRH
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Classification

Agency
FDA
Published
March 20th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
FDA-2025-V-2665-0005
Docket
FDA-2025-V-2665

Who this affects

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

Taxonomy

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

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