Good day Rabel,
If you have already determined your 510(k) (by the way it is referred to as "cleared" not approved) does not need a new 510(k) application, based on the changes being made, then it is up to you as the manufacturer how this part is placed in the market. From your explanation, it appears this is a reusable part allowing the main device to be connected to the OR table. It also appears this can indeed be considered a accessory as you are calling it a part.
There are different ways this can be brought as a "replacement" of the current EU part for now the US part (meeting the US OR table standards). However, note you should have a quality plan (service plan) or thorough change control describing how this is going to be done. As an example, when the local representative provides the new US part - is this need to be replaced by the local representative or can the user replace? What happens to the EU part? Can they use both (as part of the disposition)? All of these activities and documentation should be part of your quality system, i.e. change control as part of document control, a field change notice as part of servicing or customer support.
To answer your questions:
1. See my comment above regarding having a quality plan, service plan, or thorough change control on how this is done. You could have a Field Change Notice or similar which describes what happens when the user receives the US part (in the quality management system documentation). As part of shipping you can decide when to "switch over" from the EU part to the US part. Or you can even decide to send both at same time if this meets user needs. As part of your change impact assessment and the changes to providing either the EU part of US part just make sure all of this is documented internally to the company.
2. I am not sure understand your statement here. If you have determined not to submit a new 510(k) as stated in your post, then there is no 'device accessory application,' and already there is nothing like that in the US regulatory framework. As noted, you can document these changes internally, document how it is being managed, and all the planning around this change. If you want to send the US part separately or together with the device kit - really this is completely up to your organisation. The important point as noted above is making sure you have this all documented internally how this is going to be managed.
Hope that helps !
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-May-2022 02:56
From: Rabel Talpur
Subject: Additional part for already 510 (k) approved Medical device
Dear Regulatory Experts,
I have one querstion on which i need an expert opinion.
Description of QUestion:
We have one approved 510 k(10) device in U.S, that include one part as per European Standards, side part of device that helps to connect device to an OR table, to meet the U.S OR table standard we have modified dimension of that side part. So, that can be fixed.
Moreover, this is not leading to any material change and considering the technology / Engineering part as per the FDA guidance, the change is not leading to new 510 (k) submission.
Our Aim:
As the 510 (k) is already approved for the device including the side part that is as per European standard, that we are already selling in EU and ROW, but to fullfill End user requirement is U.S, we would like to include an additional side part (as per U.S OR table standards), and want our local representative in U.S to replace the side EU part of device with the sent U.S part.
My Solution:
1: To ship the part together with the device from EU facility, as documenting the change does not impact safety and effectiveness on device, according to FDA guidance "When to consider change for the already approved devcies".
2: To apply for device accessory application, if we would like to send the part separetly together with the devcie kit, this will take 85 days until FDA process an appllication.
I would really appreciate your valuable comments on this query.
Best,
Rabel Talpur
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Rabel Talpur
Freiburg
Germany
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