Changeflow GovPing Healthcare & Life Sciences Variance Approval Letter to Wasserman Live
Routine Rule Added Final

Variance Approval Letter to Wasserman Live

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Summary

FDA's Center for Devices and Radiological Health (CDRH) issued a variance approval letter to Wasserman Live. The specific terms, conditions, and scope of the variance are contained in the attachment, which is available as a downloadable PDF on regulations.gov under docket FDA-2026-V-2303-0003. Variance approvals granted under FDA regulations permit deviations from specific regulatory requirements under defined circumstances.

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

About this source

Every FDA document on regulations.gov, the federal rulemaking portal. This is where the agency posts variances, advisory committee meeting notices, draft guidance for comment, citizen petition responses, and procedural rules that do not get a separate Federal Register slot. Around 240 a month. FDA's heavy regulations.gov use means tracking only the Federal Register misses a meaningful chunk of what the agency does day-to-day. Watch this if you manufacture devices, submit IND or NDA applications, run a lab, or advise sponsors on FDA process. GovPing publishes each posting with the docket, document type, division (CDER, CDRH, CFSAN), and comment window where one applies.

What changed

FDA CDRH issued a variance approval letter to Wasserman Live, granting an exception or deviation from specific regulatory requirements applicable to medical devices or radiation-emitting products. Variance approvals are formal regulatory actions that authorize departures from standard requirements when justified. Affected parties should review the specific conditions outlined in the approval letter attachment to ensure compliance with any applicable terms or limitations.

Medical device manufacturers or parties subject to FDA device regulations who believe they may benefit from similar variance relief should consult the applicable FDA regulations governing variances to determine eligibility and application requirements.

Archived snapshot

Apr 24, 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

There are no documents available to view or download

Attachments 1

Variance Approval Letter to Wasserman Live

More Information
- Author(s) CDRH
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Last updated

Classification

Agency
FDA
Instrument
Rule
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Minor
Docket
FDA-2026-V-2303-0003

Who this affects

Applies to
Medical device makers Manufacturers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Variance approval Regulatory deviation
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Healthcare Product Safety

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