I agree; the FDA is not going to require you to demonstrate that the model they are selling you is covered by the 510(k).
Have the manufacturer sign a statement indicating that your product is covered. Have an internal document stating you're not making any changes. Both together should be sufficient for your purposes.
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Joshua Lust
Caledonia MI
United States
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Original Message:
Sent: 12-Nov-2021 16:40
From: Craig Simdon
Subject: Guidance for Relabeler / Repackager
Thank you for you feedback. We are not changing anything with the labeling or packaging for the product. Nothing we do would impact the safety or efficacy of the device. My question was more around if the actual manufacturer of the device states that this model is covered under their specific 510(k), my experience is that is all the documentation we need. I don't believe that the FDA is expecting that we would conduct our own internal evaluation to determine if the specific model is covered under their 510(k) when we are not modifying it in any way. As how would we claim that we have the proper expertise to conduct this evaluation?
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Craig Simdon
Brighton MI
United States
Original Message:
Sent: 12-Nov-2021 09:22
From: Joshua Lust
Subject: Guidance for Relabeler / Repackager
Repackager / Relabeler implies that your actions may have some impact on the safety or efficacy of the product. For example, if you relabel a product for an indication or patient population that wasn't cleared in the original 510(k) you're out of bounds. If you change the IFU or change the primary packaging that has a special feature to protect the product (e.g. sterility, shelf life), you're out of bounds. In this case, the previous direction you received to review the 510(k) change evaluation tree is correct; you need to make sure any action your company is taking on the product does not impact the parameters for the original device clearance. If they do, rethink your marketing strategy or document / mitigate risks.
Otherwise if you know that your actions have no impact on product safety/efficacy - e.g. you are importing it and putting your own brand label on it without making any other changes and not covering anything up, then document that and you're good to go. You're still an initial importer, which makes you a manufacturer under the 820 definition - so keep all those requirements in mind.
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Joshua Lust
Caledonia MI
United States
Original Message:
Sent: 11-Nov-2021 09:52
From: Craig Simdon
Subject: Guidance for Relabeler / Repackager
I am looking for sources to provide guidance on FDA expectations for a company that imports medical devices and performs some relabeling and repackaging? I am specifically looking for expectations around clearance of devices. If the company has received documentation from the actual device manufacturer stating "product XXXXXX is cleared under 510(k) KXXXXXXXX" is there any more the company is expected to do? I have received opinions that we should review the FDA's 510(k) Decision Tree to make our own assessment that the product XXXXXX is actually cleared under the stated 510(k). I am skeptical of this because since we are neither the specification developer or the manufacturer, how would we have the appropriate knowledge to make this assessment.
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Craig Simdon
Brighton MI
United States
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