Recent eMDR Change By FDA Asks Adverse Event Reporters About Third-Party Servicers
The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.
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AdvaMed To FDA: Add 3rd-Party Servicers, Refurbishers To Quality Management System Reg
In comments to the US FDA on its proposed QMSR rule, AdvaMed says it’s concerned that third-party entities could fall prey to hackers because of the “current geopolitical environment that is fraught with cybersecurity threats.” In its own comments, the Association of Medical Device Service Organizations says the agency should remain hands-off.
Class I Recall Of Alaris Device Is Pump’s Second In 3 Days
Third-party servicer Tenacore LLC recalled the Model 8100 infusion pumps because patients are at risk of receiving incorrect fluid dosage. The recall was designated as class I by the US FDA on 19 April; it’s the pump’s second class I recall in the span of three days.
FDA Updated Its eMDR System. Here’s What You Need To Know When Submitting Adverse Events
The US agency has completed planned modifications to its electronic Medical Device Reporting system – and added an extra field for MDR exemption numbers.