Medical Device Reporting: Improvements Needed in FDA's System for Monitoring Problems with Approved Devices : Report to Congressional Committees
The Office, 1997 - Medical instruments and apparatus industry - 56 pages
6 pages matching Safe Medical Devices in this book
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adverse event reporting assess backlog breast implant corrective actions taken database death and serious death reports deaths to fda device reporting regulation dialysis Drug Administration early warning system electronic data interchange ensure event reporting system events to fda facility reporting requirements fda and manufacturers fda received fda's ability fda's adverse event feedback final medical device fiscal years 1992 Food and Drug FTEs health care professionals hospital identify issued malfunction reports manufacturers and fda manufacturers and user Manufacturing Practices maude system mdma MDR reports medical device community medical device problems medical device reporting Medical Devices Act monitor patient postmarket surveillance system processing and reviewing protect the public provide fda reportable events reported problems reported to fda reporting device-related events reports from user reports of device required to report requires user facilities Safe Medical Devices safety alert statistical sampling submitted to fda Underreporting user facility reporting volume of reports voluntary reporting