Our regulatory approach at TrueYouOmics (TYO) centers on an agile strategy: we start with a low-risk, “wellness” framework and partner with certified labs for the wet-lab work. We then expand into advanced medical device pathways (e.g., 510(k), De Novo, IVDR) as market opportunities and patient needs evolve. This strategy has been developed with regulatory experts comparing approaches from competitors like Nucleus Genomics, Iollo, Molecular You or Dante Genomics.
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Launch as a wellness product
By keeping our product claims educational rather than diagnostic, we remain in a lower-risk regulatory category. This approach lets us rapidly enter the US & UK market without extensive approvals.
🇺🇸 US strategy: 510(k)
When we’re ready to expand medical claims, we’ll evaluate the faster route: either by pursuing a 510(k) clearance if a suitable predicate device emerges or filing a de-novo application.
🇪🇺 EU strategy: IVDR
For more robust, in vitro diagnostic claims in Europe, we’ll transition toward IVDR compliance. Our projected timeline aligns with market demand, ensuring a strategic move into regulated claims when appropriate.
By layering our regulatory steps—from wellness classification to more stringent medical device approvals—TYO remains both agile in early markets and prepared to scale. This balanced strategy underscores our commitment to safe, transparent, and impactful consumer health solutions.
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