FDA Traceability Requirements - Component lots

Nancylove

Starting to get Involved
#1
Hello forum folks,

I have a question about traceability. I was always under the impression that FDA and ISO 13485 required that distributed Class 2 devices (not implantable or life support) required traceability to the component level. I.e. what supplier lots were assembled into complete devices. FDA has no requirements for traceability if not a surgical implant or a life support/life sustaining device. ISO 13485 requires procedures on traceability which are to be based on applicable regulatory requirements (with additional requirements for implantables).

This sounds like, as long as there are no other regulatory requirements or no risks to be mitigated, tracability to component lots are not required.

Do forum members/moderators/others agree?
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
The main risk regarding component traceability is recall due to a problem with a specific component. if you don't have lot traceability you'd have to recall all devices containing that part number, regardless of lot.
 
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