GHTF Compromise On Use Error Adverse Event Reporting To Be Studied In June
This article was originally published in The Gray Sheet
Device manufacturers should only have to report adverse events involving use error when there is death or serious injury, according to a proposal under consideration by the Global Harmonization Task Force's Study Group Two (SG2).
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A proposal under consideration by the Global Harmonization Task Force's Study Group Two which would not require reporting of adverse events involving device use errors that do not result in death or serious injury represents "a significant weakening of current standards" and should not be implemented, according to consumer advocacy group Public Citizen.
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