Hello Thomas,
First, thank you Sathya for the kind reference, maybe in confidence of being able to provide an answer to the question ... hopefully haha.
Thomas, indeed you can do something like this, but let me give some advice. The more complicated you make it ... well the more complicated it will be, especially for someone from outside the company.
When a company submits a 510(k) under their name as the Applicant (or Sponsor if you like that term), when the 510(k) is cleared, they basically "own" the 510(k). Unlike other regulatory approvals or licenses around the world, a 510(k) is really written in stone. There are no amendments, supplements, or renewals, so there is either a Letter to File for a change or a new 510(k) submission. If you already had a 510(k) in and wanting two different Branches with two different indications, I would recommend having a discussion with FDA. In this case, because you will have two companies, with two 510(k)s, with two indications for use, then it would just be separate in that regard, which is fine from a submission perspective.
Now where the complication will occur is during a FDA inspection. Once you have the two 510(k)s cleared, for the same device, you would still want to keep them separate. You could market the same device with two different indications on the same IFU, same part number, same lot number assignment, etc., but as two different companies, e.g. two different Applicants so two different owners of 510(k), if you combine the packaging and labelling, this will make it complicated. During an FDA inspection the investigator wants to see Product A and you show them Product A. Then they want to see Product B and you show them Product A. You can already see where this will be confusing to someone. I also am not sure you could even write a clear explanation in your QMS which would not take time for someone to fully grasp.
Going back to the original point: if complicated, it will be complicated. You can have two companies under the same roof, in the same building, with the two different products. However, I would recommend keeping those two products as indeed, separate products. The processes could be the same such as receiving, manufacturing, testing, etc., but where the departure would occur is in the finished device configuration during packaging and labelling. It would be less complicated to assign two different finished good part numbers, two UDIs, two IFUs, two packages, two labels. You can combine everything together, but it would make it quite complicated. Plus if you read into the Act 505, 510(k), and parts 801, 807, I think an FDA investigator would find difficulty having two different indications for two different 510(k)s in the same IFU. Because that would not be the IFU they cleared during the review; nor the indications for a "singular" product. You would want to submit the
hysteroscope indications after including the urology indication in a subsequent 510(k).------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 20-Feb-2021 01:53
From: Sathya T N
Subject: Marketing two devices with different indications for use
@Richard Vincins:
Can you please add your inputs to this query?
Many thanks
------------------------------
Sathya T N
Regulatory Toxicologist
Original Message:
Sent: 13-Feb-2021 14:59
From: Thomas Lawson
Subject: Marketing two devices with different indications for use
A client has a cystoscopy that is cleared via 510(k) for use in urology and is in the midst of review of the exact same endoscope but for an indication of use as a hysteroscope in OB/GYN. Once the hysteroscope model clears, the senior management would like to market the same scope for the two different uses but in the same package-- so same unit in the pouch but with the IFU now having a cystoscope/urology section and a hysteroscope/OBGYN section.
The twist here is that the client decided to split out the hysteroscope focus into a new company but with all the same senior management. That means that the 510(k) clearances are with two different companies. I have experience of when one company licenses another device or one company buys another company and so it inherits all 510(k)s, but at the moment these two companies are separate corporations (albeit with all the same senior management).
Anyone have experience or thoughts on making a combined IFU (and also SKU numbers, lot numbers, etc) for the same device-- but with different intended uses and different 510(k) numbers-- from two different companies?
Thom