New clean room change submission - FDA Requirements

S

Sphinx

We are in the process of building a new cleanroom for one of our class II device and was eager to know what documents would we would need to submit to the FDA for this change?
Any help in this matter would be appreciated.
 
Ronen E

Ronen E

Problem Solver
Moderator
Hello Sphinx and welcome to the Cove!

Is this new cleanroom intended for just that device? is that an already-cleared device or a new one? If a cleared one, what steps did you initially take to clear it?

Is the cleanroom going to be a new facility (separate location)? If not, do you already have an equivalent cleanroom on the same site?
 
S

Sphinx

Hi Ronen - Glad to be a new member of this forum; hoping to be a contributor soon. I've answered your questions below.

Is this new cleanroom intended for just that device?
Yes that is the intent at this moment of time.

is that an already-cleared device or a new one?
Yes it is a FDA cleared device

If a cleared one, what steps did you initially take to clear it?
Traditional 510k

Is the cleanroom going to be a new facility (separate location)?
Yes - adjacent building with new equipment.


If not, do you already have an equivalent cleanroom on the same site?
Yes, the current cleanroom is functional.

I am new to the FDA arena and hence the questions.

Thanks
 
Ronen E

Ronen E

Problem Solver
Moderator
Sphinx said:
Hi Ronen - Glad to be a new member of this forum; hoping to be a contributor soon. I've answered your questions below.

Is this new cleanroom intended for just that device?
Yes that is the intent at this moment of time.

is that an already-cleared device or a new one?
Yes it is a FDA cleared device

If a cleared one, what steps did you initially take to clear it?
Traditional 510k

Is the cleanroom going to be a new facility (separate location)?
Yes - adjacent building with new equipment.


If not, do you already have an equivalent cleanroom on the same site?
Yes, the current cleanroom is functional.

I am new to the FDA arena and hence the questions.

Thanks
Click to expand...

Based on your answers, and assuming that the validated manufacturing processes in the new cleanroom are essentially the same as those utilised for manufacturing the same device in the existing cleanroom (on the same site; I take “adjacent building” to mean both buildings are on the same site), and are aligned with the information provided in the cleared 510(k), I think you don’t need to notify the FDA anything at this stage.

Make sure though to document in full detail the construction, commissioning and validation of the new cleanroom as well as the qualification and validation of its manufacturing equipment and processes. I don’t think you need to proactively submit any of that to the FDA but they’ll probably want to see them when they eventually come for their next site inspection.

Cheers,
Ronen.
 
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