Assertion: device | /r/CapableOf | present risk
Facets:
value: to health
type: TRANSITIVE-OBJECT
Source sentences:
text: Under 21 CFR 806, Medical Device Correction and Removals, manufacturers (including refurbishers and reconditioners) and importers are required to make a report to the FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.