Changeflow GovPing Healthcare Regulation FDA Variance Approval Letter
Routine Notice Added Final

FDA Variance Approval Letter

Favicon for www.regulations.gov Regs.gov: Food and Drug Administration
Published March 13th, 2026
Detected March 15th, 2026
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Summary

The FDA has issued a variance approval letter to Richard Lathrop, authored by CDRH. The letter, which contains restricted personally identifiable information, has been redacted and is available for download.

What changed

The U.S. Food and Drug Administration (FDA), through its Center for Devices and Radiological Health (CDRH), has issued a variance approval letter to Richard Lathrop. The document, dated March 13, 2026, is a formal notification regarding a variance. While the full content is restricted due to personally identifiable information, a redacted version is available, indicating a specific approval has been granted.

This notice serves as an official communication from the FDA. Regulated entities, particularly those involved in drug manufacturing or medical device development, should note this approval as it may pertain to specific product pathways or regulatory exceptions. No immediate compliance actions are mandated by this notice itself, but it signifies a regulatory decision that could impact ongoing product development or market access for the recipient.

Source document (simplified)

Content

There are no documents available to view or download

Attachments 2

Variance Approval Letter to Richard Lathrop

Restricted: Personally Identifiable Information

More Information
- Author(s) CDRH

Variance Approval Letter to Richard Lathrop_Redacted

More Information
- Author(s) CDRH
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Classification

Agency
Various Federal Agencies
Published
March 13th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Drug manufacturers Medical device makers
Geographic scope
National (US)

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Medical Devices

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