Changeflow GovPing Healthcare & Life Sciences FDA Approves Redhouse Productions Variance, Apr 22
Routine Rule Amended Final

FDA Approves Redhouse Productions Variance, Apr 22

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Summary

FDA CDRH issued a variance renewal approval letter to Redhouse Productions on April 22, 2024, extending an existing regulatory variance. The variance renewal allows Redhouse Productions to continue operating under modified regulatory terms for the device or activity covered by the original variance. Variance renewals maintain the holder's existing regulatory flexibility while confirming continued compliance with applicable requirements.

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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 This is where the agency posts variances, advisory committee meeting notices, draft guidance for comment, citizen petition responses, and procedural rules that do not get a separate Federal Register slot.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 renewed a variance previously granted to Redhouse Productions, maintaining the regulatory exception that allows the firm to operate under modified requirements for a specific device or activity. The variance renewal approval letter was issued on April 22, 2024, and is associated with docket FDA-2023-V-2753.

Redhouse Productions and other variance holders should monitor the conditions of their approved variances to ensure ongoing compliance and timely renewal applications. Variance approvals are binding regulatory instruments and may be subject to review, modification, or revocation if conditions change or requirements are no longer met.

Archived snapshot

Apr 23, 2026

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Content

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Attachments 1

Variance Renewal Approval Letter from FDA CDRH to Redhouse Productions

More Information
- Author(s) CDRH
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Last updated

Classification

Agency
FDA
Published
April 22nd, 2024
Instrument
Rule
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Minor
Document ID
FDA-2023-V-2753-0005
Docket
FDA-2023-V-2753-0005

Who this affects

Applies to
Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Variance renewal Device regulation
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Regulatory Affairs
Compliance frameworks
FDA 21 CFR Part 11
Topics
Consumer Protection Healthcare

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