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


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Some Related Topic Tags
convenience kits (medical device), fda requirements, guidance documents, replacement parts, traceability of parts materials and products
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  Post Number #1  
Old 30th March 2015, 01:18 PM
bcsnave

 
 
Total Posts: 27
Question What is the FDA guidance regarding selling replacement parts and traceability?

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?

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  Post Number #2  
Old 1st April 2015, 11:55 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,326
Re: What is the FDA guidance regarding selling replacement parts and traceability?

A Quick Bump!

Can someone help?

Thank you very much!!
  Post Number #3  
Old 1st April 2015, 07:15 PM
Ronen E

 
 
Total Posts: 3,736
Re: What is the FDA guidance regarding selling replacement parts and traceability?

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.
Thanks to Ronen E for your informative Post and/or Attachment!
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