What is the FDA guidance regarding selling replacement parts and traceability?

bcsnave

Involved In Discussions
#1
Our organization manufactures a low risk Class II bed that has electronics that raises and lowers the bed. When someone calls for a replacement component out of warranty, and the facility has hundreds of beds, the order is not associated with a device serial number. (think of going to an auto parts store and purchasing replacement shocks or brake pads there is no VIN number associated with the purchase)

What is the FDA guidance regarding selling replacement parts and traceability?
:2cents:
 

Ronen E

Just a person
Super Moderator
#3
Hi,

I don't think FDA bothers to oversee low-risk repairs (I recommend a documented risk evaluation to support that it is indeed low-risk). The only issue I can see is when a faulty component requires a field action and there's no traceability within an institute, you might have to advise replacement in hundreds of beds, many of them actually in perfect condition as far as that component is concerned.

(I'm assuming that you do have lot/batch traceability of spare parts sold, at the institute / customer level.)

Cheers,
Ronen.
 
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