January 27, 2026
Time for a MAUDE revamp
According to the FDA
“The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.”
When it comes to the insulin pump side of MAUDE we have reached the point where the database is in serious need of revision. In the past the database did its job well allowing the agency to identify problems. This was before the advent of AID systems which now dominate the insulin pump landscape.
Remember AID is a collection of devices and software all working . . .
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