In a recent post Ginger Glaser reported concern. She said, "having now been through two different situations of FDA using their 'early signal detection process' in which the entire signal was 'there seem to be a lot of MDRs' …While I read the guidance document about early signal detection, I didn't know that FDA had actually implemented it and sent out information. In particular, Ginger said, "given that HOSPITALS think that FDA has actual facts when they send out notices", which raises a concern for me.MDR signals should be a rate calculated using numerator (number of MDRs) and a denominator (number of devices or procedures that could result in an MDR). FDA does not have, as far as I know, the denominator information.Can somebody point me to information about early signal detection in practice. In particular, does FDA include the communication on its website for the public to see?
This page gives an overview that's pretty consistent with my experience:
FDA seems to call it "Signal Management" and it's not at all a transparent process. I'm not aware that anything is public, unless a safety notice is issued. It's also not very transparent to the manufacturer, as they are often unaware of whether FDA's looking at a device class or just their device. Worst is that the manufacturers are not usually informed of any resolution--it just ends up going silent (which is admittedly better than a safety notice).
In the several times I've observed it happen, the process starts with a list of questions for the manufacturer--including sales by year. So that gives them a denominator of sorts, though it's often not clear that all devices sold were used in patient care. Other requests include any related CAPAs or investigations information.
Hope that's helpful.
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