adv_webdev

Starting to get Involved
#1
Our company is a distributor for a product manufactured by another company. The other company has the 510K. Are we in anyway responsible for the Design History Files?
 

Michael Malis

Quite Involved in Discussions
#4
Re: Is distributor responsible for Design history files

Is it because 21 CFR 820.30 doesnt consider distributor as manufacturer?
Because only manufacturer has responsibility and authority for all personnel who manage, perform and assess work related to quality of this product!

As distributor, you are not involved in Design or Manufacture of the device, therefore, you don't generate any Device History documentation.

Hope this helps,
Mike
 

adv_webdev

Starting to get Involved
#5
Mike,
You make a good point about the device history documentation (I guess you are talking about batch records). I was worried about Design History Files (Design Master REcords). As a distributor, are we responsible to ensure that they are all in order? If there is an FDA audit, could we point a finger to the actual manufactuer and if they (FDA) actually find that there is something missing there, are we held responsible?

Prema.
 

AndyN

A problem shared...
Staff member
Super Moderator
#6
You are not responsible for the design and manufacture of the product - pure and simple. All kinds of questions may be asked of you during an audit. You cannot be (reasonably) held responsible for what happens at the manufacturers. Don't be overly concerned.
 

Michael Malis

Quite Involved in Discussions
#7
Mike,
You make a good point about the device history documentation (I guess you are talking about batch records). I was worried about Design History Files (Design Master REcords). As a distributor, are we responsible to ensure that they are all in order? If there is an FDA audit, could we point a finger to the actual manufactuer and if they (FDA) actually find that there is something missing there, are we held responsible?

Prema.
Prema,

You are not resposible for Design or Manufacture of the product.
DMR, DHR, DHF records are generated by manufacturer. As distributor, you responsible for product traceability (in case of product recall) so you need to maintain records of the Lot Numbers for disposible products or Serial Numbers for Instruments.

I hope this is beneficial.
Regards,
Mike
 
J

jwgideon123

#9
To tag onto the original post - I work for an initial importer / distributor of Med Devices in the US as the QA/RA rep. We do supply our own artwork to the suppliers for private labeling. I have been keeping up with Design History of our artwork, revision control, etc.
One question I do have regarding regulatory as a distributor (in the past, I have worked at the manufacturer or med devices) - when evaluating / selecting suppliers for products, how far into the details should I go? For instance, I do check to ensure they have a 510K for the specific products, but for sterile products, I will usually ask to see their dose settings / does audits or sterilization validations. For expiration dates, I will ask to see stability studies to confirm it can hold up to FDA scrutiny. Is this too much? Should I just be ensuring that the facility is registered, the product is registered and the 510K exists (for applicable products requiring 510Ks)?
 
M

MIREGMGR

#10
There are no hard and fast rules. It's reasonable for you as a distributor to do as much as you think is appropriate to protect your customers, reputation and business continuity. You might want to go considerably farther with less well established suppliers, and you might determine that just periodic supplier requalification plus C of Cs is enough with more established suppliers.
 

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