Do I need to Register with FDA? How shall my structure of processes look like?

P

patilrahuld

Involved In Discussions
Hello,

Need your input.

We are a small rubber component manufacturer. Do we need to register with FDA. One of our customer's is asking us to get registered based on the fact that the rubber part we supply to them is treated by them as a finished device since it is a part of a kit. Our customer does Inspection/Packaging/Labeling/Sterilization once parts are received and hence we think that we not need to get registered. PLEASE ADVICE.

If we have to get registered, what are the odds that we will be audited by FDA? We do not feel that we are set up to comply with FDA from the process stand point.
How shall FDA processes look like? Is there any guideline regarding the look and set up of a facility that is FDA registered? DO i need to change my document structure? if yes, how?

Thank you
 
Ronen E

Ronen E

Problem Solver
Moderator
patilrahuld said:
Hello,

Need your input.

We are a small rubber component manufacturer. Do we need to register with FDA. One of our customer's is asking us to get registered based on the fact that the rubber part we supply to them is treated by them as a finished device since it is a part of a kit. Our customer does Inspection/Packaging/Labeling/Sterilization once parts are received and hence we think that we not need to get registered. PLEASE ADVICE.

If we have to get registered, what are the odds that we will be audited by FDA? We do not feel that we are set up to comply with FDA from the process stand point.
How shall FDA processes look like? Is there any guideline regarding the look and set up of a facility that is FDA registered? DO i need to change my document structure? if yes, how?

Thank you
Click to expand...

Hi,

What is the nature of this "component" / device? If taken out of the kit context, can it (and is it likely to) be used on its own, as a medical device?

If the answer is yes, I'd say that you are acting as a "Contract Manufacturer" of this device, and need to register as such.

As a registered Contract Manufacturer you are likely to get inspected by the FDA, sooner or later. This might take years to take place, depending on various factors.

FDA's requirements and expectations regarding processes, documentation and otherwise depend on what exactly the device is and how it is classified (as in what Procode - three letter code - is designated). I can't say what the Procode is without knowing more about the device.

Cheers,
Ronen.
 
Last edited:
M

MIREGMGR

If your customer is telling you that they regard your product as a medical device, and you don't want to be a medical device maker, don't sell to that customer.

If your product meets the functional definition of a medical device, and you sell it to someone that you reasonably should know regards it as a medical device, you are a medical device maker.

If you're a medical device maker and you don't conform to the regulatory requirements for medical device manufacturing, sooner or later you will be caught.

It's not a good idea to cheat on the rules. Either conform, or don't sell medical devices.
 
P

patilrahuld

Involved In Discussions
Ronen,
Customer stated that the parts are" Sold as a kit with the device and the accessory".
Also, we have been making this parts for more than 15 years and this request just came in from the customer.
Can you advise as what changes i have to make into my quality management system to comply with FDA?

Rahul
 
Ronen E

Ronen E

Problem Solver
Moderator
patilrahuld said:
Ronen,
Customer stated that the parts are" Sold as a kit with the device and the accessory".
Also, we have been making this parts for more than 15 years and this request just came in from the customer.
Can you advise as what changes i have to make into my quality management system to comply with FDA?

Rahul
Click to expand...

Hi Rahul,

I'm sorry, but the sentence

the parts are" Sold as a kit with the device and the accessory".
Click to expand...

Doesn't clarify much to me. Who is the device? What is the accessory? Is "your" product one of them? Which? Or maybe it is just a component in one of them? And what is this device / kit, in specific?

I understand that you might not be able to share this information in a public forum, but please understand that our ability to help you with so little input is very limited. If you prefer, please send me a private message with more details.

Regarding your other question, I estimate that it's not just a question of introducing a few changes to your QMS. If you didn't make an intentional effort to comply with the regulation (the whole package), and now you have to, there will be many things to look at - some directly related to the QMS, and others. What exactly you need to do needs to be determined through a specific, on-site gap analysis, by someone that has full access to the relevant information and systems.

Last, the fact that you've been going the way you did for 15 years is not of great relevance, IMO. Perhaps you / your client were not compliant and were (not necessarily intentionally) flying under FDA's radar. The important thing is that now there is an apparent discrepancy that has to be dealt with. It may be a result of a regulation change (happens from time to time) or just a result of somebody noticing something that they didn't notice earlier. Again, it's difficult to say without knowing what kind of device we're talking about.

Cheers,
Ronen.
 
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