Class I Medical Devices?
by Matthew ~ February 15th, 2008. Filed under: News.
The last time I checked, the FDA web site defines a Class I medical device as presenting, “minimal potential for harm to the user and often simpler in design.” The examples used are, “elastic bandages, examination gloves, and hand-held surgical instruments.” However, FDA is now proposing that the software that goes into Class III devices (for example, implantable pacemaker pulse generators and endosseous implants) should be regulated according to Class I rules. In other words, device software should be regulated in the same manner as an elastic bandage.
Hmm… Anyone else thinking this doesn’t sound like such a great idea? Adverse events on medical devices can be much more serious than pharmaceuticals due to surgical intervention. Imagine trying to remove a heart or brain pacemaker because of a software/firmware bug? I don’t see the case for reclassifying device software. If they are going to reclassify, why go from Class III to Class I? Shouldn’t they try Class II first? Anyone want to help me on this one?
[via NeoTool] FDA Device Classification