Classifying a Multiple Risk Medical Device System

M

Maxmaxi

#1
Hi,

I am trying to understand how to Classify a medical system that has 2 subsystems, where each subsystem poses a different risk.
For example, a system that has an active cardio-vascular implant and an external RF component.
How would one go about classifying this? and more importantly - can anyone provide a link to the FDA site that deals with this issue?

Thanks!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello and welcome to the Cove :bigwave:

The FDA classification mechanism doesn't work by risk. It works by device type, and formal risk level (=class) is a result. Once you know the applicable ProCode (FDA 3-letter code of the device type), you'll know the class (and the risk level FDA assigns to that device type).

Off the top of my head, I think you should try to assign 2 ProCodes, one to each sub-system, unless you can find an existing code for such a system comprising similar sub-systems (is there already a cleared predicate on the USA market?). If you go by 2 codes then I guess you'll have to manage your clearance either as 2 separate processes (for the 2 sub-systems) or as a single process, going by the higher risk (with the lower risk sub-system covered as an ancillary function). Please note that this is just a preliminary guess based on general knowledge - I didn't research the topic (some people call it "work"). I'm pretty sure that there is some sort of relevant guidance available from the FDA.

Cheers,
Ronen.
 
M

maaquilino

#3
Hi,

I am trying to understand how to Classify a medical system that has 2 subsystems, where each subsystem poses a different risk.
For example, a system that has an active cardio-vascular implant and an external RF component.
How would one go about classifying this? and more importantly - can anyone provide a link to the FDA site that deals with this issue?

Thanks!
These may help:

http://www.fda.gov/medicaldevices/d...nce/overview/classifyyourdevice/ucm051512.htm

http://www.fda.gov/medicaldevices/d...dance/overview/classifyyourdevice/default.htm

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm077210.htm

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm267829.htm


Articles on devices that sounds similar to your example; doing a search on the FDA website for these devices may garner you more info that will help you.

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm399024.htm

http://www.accessdata.fda.gov/cdrh_docs/pdf4/h040006c.pdf
 
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