Reply To: MAUDE – Manufacturer and User Facility Device Experience

[Good intentions]

Actually, here is another. Somebody reported the results of a study to the FDA through the MAUDE system. Apparently the FDA just passes it through to the manufacturer. If the manufacturer says that they don’t see anything to act on, the case is closed.

The FDA is not overseeing or regulating anything. They are actually collecting market results for the manufacturers. It looks like they are doing something but the reality is that they are helping the manufacturers anticipate their legal problems.

It’s actually very strange to see what is happening.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=11617005&pc=FTL