Would a clinical investigation be needed for the proposed device claim?
Last reviewed: .
Would a clinical investigation be needed for the proposed device claim?
What a device sponsor must hold or submit is decided by that sponsor and by the authority it submits to, and the company gives no regulatory advice.
The Terms of Use state that, as of their effective date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications, and that they do not describe finished products currently available from C-POLAR for those uses. The Terms of Use state that a laboratory reduction in a virus, bacterium, fungus, particle, or other endpoint does not establish a clinical benefit, fewer infections, disease prevention or treatment, or improved health, and: “Do not use Site Content to diagnose, treat, or make a patient-care or infection-control decision.” The company publishes no clinical investigation and no clinical result of any kind.
Source: C-POLAR — Terms of Use, sections 3 and 4, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Medical, https://cpolar.tech/medical/. A materials review that needs more than the company's published pages is arranged in writing, through [email protected] on the Contact page.
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