Selling Medical Device Components to US hospitals and doctors

katiesam

Starting to get Involved
#1
We are a UK based company distributing medical devices across the globe and have been approached by a surgeon in the USA who would like to buy a component from us. We are currently selling this custom made component to one hospital in the UK, where it is then added to other components to make up a device used during surgery (think along the lines of a particular connector used to make up a tubing set). This surgeon in the US has heard about it and would also like to buy some. We are a registered establishment with the FDA already as we export a device that gained 510k clearance last year. Does anyone know what we would need to do to start selling this component to the surgeon in the US? I can't seem to find any guidance to fit this particular example.

Any help is very much appreciated.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
We are currently selling this custom made component to one hospital in the UK, where it is then added to other components to make up a device used during surgery (think along the lines of a particular connector used to make up a tubing set).
1. Can this component be used as a medical device on its own, i.e. does it have any medical purpose without being integrated with other components? It would actually help if you said what it is (if confidential, you're welcome to send a PM).

2. By "custom made", do you mean that each individual unit is being somehow customised for each patient, or simply that you've customised that model for that specific customer (but all its units are identical)?
 

katiesam

Starting to get Involved
#3
Thank you for your answer. I will clarify each point separately:

1. The component cannot be used as a device on it's own. It is a metal tip that the hospital will be putting on to a venous line, effectively making their own venous cannula.

2. The latter; all the units are identical but the component has been designed for a specific customer.

Thanks again
 

Ronen E

Problem Solver
Staff member
Super Moderator
#4
Thank you for your answer. I will clarify each point separately:

1. The component cannot be used as a device on it's own. It is a metal tip that the hospital will be putting on to a venous line, effectively making their own venous cannula.

2. The latter; all the units are identical but the component has been designed for a specific customer.

Thanks again
Thanks for clarifying.

You will be making a component and not subject to the USA medical devices regulations in this specific context. The regulatory responsibility will rest with whoever will be integrating it into a medical device (not necessarily the entity producing the item, but the one on whose behalf this will be done, e.g. the surgeon, hospital etc.)

Your customer may have all sorts of requirements applied to you through contract, including echoes of regulatory requirements that apply to them, however from your perspective that would be more a commercial/contractual obligation than a regulatory one. For instance they may want to enforce some cleanliness requirements on your production.
 

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