Regulatory Open Forum

Hi all, 

Looking for some feedback from the group.

If we have a list of class II 510(k) exempt IVD products that we are planning to bring to market. The list is individually exempt, but if we bulk them together does it still falls within class II 510K exempt or does the classification change? or is there further analysis that needs to be made?

To clarify further, the IVD products will function individually in the instrument. 

If is falls within the same class, is there anything else that needs to be done except for listing the product in FURLS and having all the internal documentation in place?

Thank you in advance!

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Suraj Maharjan
Sr. Regulatory Affairs Specialist
United States
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Do you sell the devices as multiples or individually to users?

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[Robert] [Falcone] PhD, FTOPRA, FRAPS
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Original Message:
Sent: 17-Oct-2022 11:21
From: Suraj Maharjan
Subject: Class II 510k Exempt device

Hi all,

Looking for some feedback from the group.

If we have a list of class II 510(k) exempt IVD products that we are planning to bring to market. The list is individually exempt, but if we bulk them together does it still falls within class II 510K exempt or does the classification change? or is there further analysis that needs to be made?

To clarify further, the IVD products will function individually in the instrument.

If is falls within the same class, is there anything else that needs to be done except for listing the product in FURLS and having all the internal documentation in place?

Thank you in advance!

------------------------------
Suraj Maharjan
Sr. Regulatory Affairs Specialist
United States
------------------------------

Suraj,

It depends if the indications for use (intended use) exceed the xxx.9 from the regulations.  Meaning if all of the IVD devices as 510(k) Exempt are used individually or even if used together, do not exceed the requirements under xxx.9 then probably ok.  It really depends if the combination or if using them together exceeds the limitations of the regulations.  Also have to mirror Robert's question because there is a significant difference between selling them together to be individually or selling them together to be used in conjunction with each other.  As you indicate they are to be used individually on the instrument, then seems like they are still 510(k) Exempt and you are only selling them together.  However, if you had another piece or software in there where the results of many tests are combined for the healthcare professional's decision, then again this might exceed the limitations of the regulation.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 17-Oct-2022 17:10
From: Robert Falcone
Subject: Class II 510k Exempt device

Do you sell the devices as multiples or individually to users?

------------------------------
[Robert] [Falcone] PhD, FTOPRA, FRAPS

Original Message:
Sent: 17-Oct-2022 11:21
From: Suraj Maharjan
Subject: Class II 510k Exempt device

Hi all,

Looking for some feedback from the group.

If we have a list of class II 510(k) exempt IVD products that we are planning to bring to market. The list is individually exempt, but if we bulk them together does it still falls within class II 510K exempt or does the classification change? or is there further analysis that needs to be made?

To clarify further, the IVD products will function individually in the instrument.

If is falls within the same class, is there anything else that needs to be done except for listing the product in FURLS and having all the internal documentation in place?

Thank you in advance!

------------------------------
Suraj Maharjan
Sr. Regulatory Affairs Specialist
United States
------------------------------