Changeflow GovPing Healthcare Variance Approval Letter to Primo Entertainment...

Routine Rule Added Final

Variance Approval Letter to Primo Entertainment Inc

Regs.gov: Food and Drug Administration

Detected April 7th, 2026

Summary

FDA's Center for Devices and Radiological Health (CDRH) approved a variance request from Primo Entertainment Inc, granting the company relief from specific regulatory requirements under federal standards for electronic products or radiation-emitting devices. The variance pertains to the company's entertainment products that fall under FDA's radiation safety jurisdiction.

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What changed

FDA CDRH granted Primo Entertainment Inc approval for a variance from standard regulatory requirements applicable to electronic products or radiation-emitting devices. This variance permits the company to deviate from specific federal standards that would otherwise apply to their entertainment products under FDA jurisdiction.

Primo Entertainment Inc must adhere to any conditions specified in the variance approval and ensure all alternative compliance measures meet FDA safety requirements. Other manufacturers of similar entertainment devices should monitor this variance to assess whether comparable relief might be available for their operations.

What to do next

Review variance terms and conditions
Ensure compliance with approved variance scope
Retain documentation for regulatory inspection

Source document (simplified)

Content

There are no documents available to view or download

Attachments 1

Variance Approval Letter to Primo Entertainment Inc

More Information
- Author(s) CDRH
Download

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Source

Regs.gov: Food and Drug Administration regulations.gov/search?agencyIds=FDA&sortBy=postedDate&sortDirection=desc

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency

FDA

Instrument

Rule

Legal weight

Binding

Stage

Final

Change scope

Minor

Document ID

FDA-2026-V-2696-0003

Docket

FDA-2026-V-2696

Who this affects

Applies to

Manufacturers Medical device makers

Industry sector

3345 Medical Device Manufacturing

Activity scope

Radiation-emitting products Variance compliance Device manufacturing

Geographic scope

United States US

Taxonomy

Primary area

Medical Devices

Operational domain

Regulatory Affairs

Topics

Product Safety