Does the duration of patient contact change the required biological evaluation?
Last reviewed: .
Does the duration of patient contact change the required biological evaluation?
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: “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.”
What the company states about its own testing is on the Validation page. The Validation page states that NanoFlashing™ is tested under Good Laboratory Practice to US EPA Health Effects Test Guidelines, and names Product Safety Labs, Study 65321, Study 65322, Study 65323 and Study 65324. Those are studies of the material under the guidelines named, and they are not a biological evaluation of a finished device.
Source: C-POLAR — Validation, https://cpolar.tech/validation/; C-POLAR — Terms of Use, sections 4 and 5, https://cpolar.tech/terms/. A copy may be made available on our review of the request.
Reviewed on .
All questions