Instructions for Use of Finished Medical Device (IFU)

dbaz000442

Starting to get Involved
My company does not manufacturer a finished medical device. We supply a PCBA to a company who installs that PCBA into a Class 2 Medical Device who then markets that device for sale to doctors.

Is it a requirement for my company to have a copy of the Instructions for Use of Finished Medical Device (IFU) included in our DMH/DMR files, though we do not build/are not manufacturing the finished medical device registered with the FDA?
 

yodon

Leader
Super Moderator
I don't know of a reason or any regulatory requirement for you to keep a copy of the IFU in your files.

I'm curious what triggered the question? Did someone say you should?
 

dbaz000442

Starting to get Involved
Our ISO 13485:2016 external auditor requested to see this document and I was told I should have a copy saved in our DHR/DMR folder where we keep all the manufacturing documents for the PCBA we sell to our customer. I do not see any where in CFR 21 820 a requirement to have this document seeing we do not build the final medical device.
 

yodon

Leader
Super Moderator
Ask the auditor for the requirement! If already issued a NC, challenge it. (Do be sure to check your internal procedures before doing so in case you have something written that indicates you should have a copy in your files.)
 

dbaz000442

Starting to get Involved
The auditor did not issue me a NC but told me to make sure I have it for next years audit. We do not have this requirement listed as a required document in any of our procedures/SOP's. I will definitely request the auditor to show where in the ISO 13485:2016 standard and CFR 21 820 requires a company who does not build/manufacturer the finished medical device to have readily available, a copy of the IFU. Just trying to find out if anyone else had such a request.
 

ChrisM

Quite Involved in Discussions
Oh dear, another "dumb" auditor. If you only make/assemble the PCBA and it cannot function on its own without other sub-assemblies etc, what use would the product's IFU be to you?
 

dbaz000442

Starting to get Involved
Oh dear, another "dumb" auditor. If you only make/assemble the PCBA and it cannot function on its own without other sub-assemblies etc, what use would the product's IFU be to you?
I agree, but when asked again for it next year during a surveillance audit, I will definitely ask the auditor to show me where it states that a vendor that supplies a component but not the finished medical device, is required to have this document on file. The only benefit I see of having this document is that it shows me that the finished device is a Class 2 device and what the device is being used for which we know in advance prior to assembling PCBA's.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Does your customer provide feedback to you on your product performance? If so that’s enough.
 
Top Bottom