FDA 510(k) Platform & Regulatory Directories | AI Tools, Consultants & Providers | Cruxi

Verified Partner

LCA & Compliance Software

ID: cruxi • Verified Listing

Service Description

FDA 510(k) Platform & Regulatory Directories | AI Tools, Consultants & Providers | Cruxi Regulatory Submissions. Simplified. Start Free — No Card Required 14 regulatory services. AI-powered workflows. Expert guidance. ★★★★★ 4.8/5 • 150 reviews Professional regulatory support powered by a chain of AI agents. From FDA 510(k) to De Novo, PMA to global markets—intelligent automation, automated compliance checks, and expert guidance at every step. What teams say Feedback from regulatory leaders using Cruxi. “ Cruxi delivered a highly insightful report that proved valuable for our work, even as a few initial technical issues were being resolved. Ricky Solorzano CEO, Linton Lifesciences “ The 510(k

Key Credentials & Features

EPR compliance
Reporting support
Certification

Supported States

CA CO OR MN

Managed Materials

flexible-film

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State Deadlines

This provider operates in states facing active reporting obligations:

California SB

California producers with individual source reduction obligations should prepare for the August 1, 2026 individual source reduction plan milestone.

Due: Aug 1, 2026

Colorado HB

Colorado obligated producers must submit their annual supply report for the 2026 calendar year to the CAA by May 31, 2027. Mandatory producer dues to the CAA are also in effect. Producers who have not yet registered should do so immediately — registration opened October 1, 2024.

Due: May 31, 2027

Oregon HB

Oregon's EPR program is subject to a preliminary injunction secured February 6, 2026 by Sidley Austin (on behalf of NAW members). A full constitutional trial begins July 13, 2026. Producers NOT covered by the injunction remain subject to CAA registration, the May 2026 annual reporting obligation, and ongoing fee payments. Monitor the trial outcome closely.

Due: Jul 13, 2026

Minnesota HF

Minnesota's EPR program is in early implementation. A statewide needs assessment is due by December 31, 2026. Producers must maintain active annual registration with the CAA and state commissioner. De minimis exemption: under 1 metric ton of covered material or under $2M in global gross revenue. Full stewardship fees begin January 1, 2029.

Due: Dec 31, 2026

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