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The FDA’s 2024 authorization of Vaporesso’s LUXE XR Max and SMOK’s RPM 5 open systems signals shifting PMTA evaluation criteria:
- Leakproof Mandates: Both devices demonstrated <0.05g/hr liquid leakage under ASTM F3322-23 testing protocols.
- Child-Resistant Innovations: RPM 5’s magnetic pod lock requires 6.5N force to disengage, exceeding CFR 1700.20 standards.
- Documentation Depth: Successful applications included 124,000-page toxicology reports and 18-month user habit analyses.
Market Impact: Expect 35–40 new PMTA submissions targeting open systems in 2024, with FDA review timelines compressed to 13 months under PDUFA VII guidelines.
