Establishment License for Medical Device Suppliers

M

mogluk

#1
I am trying to collect a DHR and DMR for a company I just joined.

they essentially are taking a device that is commercially made for another use (non regulated) and are tying it into a 510k device ( device A, software, sample receptacle). My question is will I need to get an establishment ID # for the manufacturer of Device A.

the device is being screened 100% upon receipt at our facility.

I am not sure if the manufacturer of Device A has an agreement or is aware of our use as a medical device they are not ISO nor obviously a medical manufacturer establishment or signed up on the FDA website.

Do I need to sign them up even though we are the "Labeled" manufacturer of the final medical device?

I know its kinda convoluted but feel free to ask me questions.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi,

It seems that significant sorting is needed here, before any action is taken. First thing first.

I assume that by "collecting a DHR/DMR" you meen assembling or compiling. I also assume you actually referred to a DMR and a DHF (Design History File). Reminder - the DHR is the compilation of records that shows that the device (each and every unit / batch / lot) was manufactured in accordance with the DMR; while the DHF is a compilation of the D&D documentation (under Design Control). Typically, putting together a compliant (and useful, and manageable) DMR / DHF is a coordinated, thoughtful effort, rather than just "collecting" existing documents; unless you have a very well-oiled system that already produced some such files (doesn't sound like your case but I may be wrong).

To the point - I understand that "device A" is the non-medical device that you use as a component in the medical device you make (and label). Right? Not sure what kind of product it is, though. I also understand that you use another product - a 510k cleared medical device - as a component. Not sure what that device is either (or how software is involved in all this). A clarification would go a long way in enabling effective advice.

Also, what do you mean by "tying into"? is it integrated (in what way)? is it used as an accessory? etc.

Another question - is all this related to IVD?

Screening at entry to your premises is of lower relevance, as much as I can say at this stage.

To me, it sounds that "A" is just a component to your own medical device, and its maker is a "component manufacturer". As such, they are not required to register as an establishment, and do not officially require ISO certification, unless your own purchasing controls require that. It's recommended that they are aware of what you're using their product for (so they can better cooperate with you), and that your mutual understandings are captured in a contract / quality agreement, but this is not a regulatory requirement and would depend on both companies practices and established procedures.

Cheers,
Ronen.
 
M

mogluk

#3
your last paragraph is what I thought but I wanted to touch base with some others.

its a drugs of abuse screener. device A + Software (algorithim on computer attached to screener) + specimen receptacle = 510k device.

yes I am compiling a DMR first and then organizing the myriad documents that the company thought they needed for a DHF. I mistyped on DHR it is a DHF.
 
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