Variance Approval Letter to Primo Entertainment Inc
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.
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
Archived snapshot
Apr 7, 2026GovPing 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 Primo Entertainment Inc
More Information
- Author(s) CDRH
Download
Related changes
Get daily alerts for Regs.gov: Food and Drug Administration
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from FDA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when Regs.gov: Food and Drug Administration publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.