Would integrating the material change the intended use of an existing medical device?
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Would integrating the material change the intended use of an existing medical device?
What the intended use of a device is, and whether a change alters it, is determined by the device's own sponsor under the rules that apply to that device.
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. They also state: “A test of a material, component, sample, or prototype does not establish the safety, efficacy, suitability, durability, compatibility, manufacturability, scalability, or performance of a finished product.” and that images and descriptions may show concepts or prototypes, which are not specifications, instructions, validation reports, recommendations, warranties, offers, promises, or commitments. The Terms of Use state: “A prospective partner or manufacturer must perform its own testing, validation, compatibility work, safety review, risk review, and quality controls for its proposed product and use.” The Terms also state: “Nothing on the Site authorizes anyone to manufacture, integrate, market, resell, or describe a product as C-POLAR-enabled.”
Source: C-POLAR — Terms of Use, sections 4 and 5, https://cpolar.tech/terms/; C-POLAR — NanoFlashing™ Medical, https://cpolar.tech/medical/.
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