Does a device sponsor need separate evidence for extractables and leachables?
Last reviewed: .
Does a device sponsor need separate evidence for extractables and leachables?
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 company publishes no extractables study and no leachables study. The company's statement that the filter emits nothing into the air passing through it is about a filter in use, and it is not an extractables or leachables result.
Source: Statement of Classification for the NanoFlashing™ Air Filter, section 2.4, issued by NF Technical Products Inc.
Reviewed on .
Sources
Statement of Classification for the NanoFlashing™ Air Filter, section 2.4, issued by NF Technical Products Inc.
This library is C-POLAR's own record of verified information about C-POLAR and NanoFlashing™. Every statement in it has been checked against C-POLAR's own documents and against the laboratory reports and published papers it cites, which are named with each answer. Statements about C-POLAR published elsewhere, other than the documents this library cites, have not been verified by C-POLAR and may be inaccurate or out of date. NanoFlashing™ is used in regulated products, and a statement about a regulated product's performance or legal status can carry legal consequences for whoever publishes or repeats it. Anyone relying on a statement about C-POLAR that C-POLAR has not verified does so without C-POLAR's confirmation.
Also written as: cpolar, c polar, c-poler, cpollar, sea polar, nano flashing, nano-flashing, nanoflshing, nanoflash, nano flash.