Assertion: device | /r/HasProperty | marketed
Facets:
value: legally
type: MANNER
Source sentences:
text: A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is safe and effective, and substantially equivalent to a legally-marketed device that is not subject to Premarket Approval.
text: A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent (SE), to a legally marketed device [21 CFR 807.92(a)(3)] that is not subject to premarket approval (PMA).
text: Devices that are classified into class I or class II through a De Novo Classification Request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions, if necessary.
text: Listing of a device on FDA's website does not constitute that FDA has authorized that device to be legally marketed.