FDA Sub contractor Requirements

[a harrison]

Hello all,

I currently work as the quality engineer for a (ISO 9001) company that primarily produces plastic products for the retail display market, although we do produce other plastic related items.

We have just taken on a contract to manufacture transfer boards (basically a flat plastic board used to help individuals move from bed, chair etc to a wheelchair).

This product is classed as a medical device and, because our customer sells to the USA, we have been told we need to be FDA certified.

I have worked for an FDA certified company before, but I have never been in the position where I have to apply and manage the system required.

I have done the usual research and have read through several "Title 21" documents, but it can get a bit confusing.

Is there anyone out there who can give me some pointers on how to progress this?

Do we actually need FDA approval ourselves if we are supplying to a UK company, regardless of the fact that it is there decision to export to the USA?

If it is the case that we do need approval, how valid is our ISO 9001 certification? does it cover us?

Any guidance (or help on where to look) would be appreciated.

 

[Ronen E]

Why the sad face?...

Do we actually need FDA approval ourselves if we are supplying to a UK company, regardless of the fact that it is there decision to export to the USA?

“FDA approval” is not the best term for what you’re asking. I guess the relevant question would be what actions you need to take to meet FDA requirements that apply to you. The answer depends on what you make. Is it the finished / the whole product (device), or is it just a component to be included in an assembly / further processed etc.? If just a component, you don’t have direct obligations towards the FDA. Your client might, though, so they need to study their position thoroughly, and then they might pose some specific requirements to you (eg via contract or purchase order) to support their endeavour to comply. Then, your job would be to make sure what they require is reasonable to you, considering the business value as you perceive it. If, however, you manufacture a finished device for your client you might qualify as a Contract Manufacturer in FDA terms. You can read about CM obligations on the FDA website. The specifics depend on the device classification - the easiest way to classify is to identify an identical (or very similar) device already on the US market, and look up its classification on the FDA database.

Give us a shout if you get stuck.

If it is the case that we do need approval, how valid is our ISO 9001 certification? does it cover us?

Unfortunately its almost useless, except the fact that it means you already have an up-and-running QMS. Where QMS requirements apply under the FDA, the binding reference is 21 CFR 820 (which is close, but not identical, to ISO 13485).

Cheers,
Ronen.