Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all, 
could you please provide guidance on how to proceed from a regulatory point of view with a class I accessory to a class II parent device?

1) Can the manufacturer autonomously decide that the accessory is a class I device based on risk analysis and simply apply design controls on it, without submitting pre-market documentation to the FDA?
2) Is the accessory classification request mandatory or just a recommendation? My understanding is that FDA treats this request as a Q-sub so it should be up to manufacturer to decide whether or not to discuss it with the FDA. 
3) Shall the accessory still be included in the 510k of the parent device and proven to be substantial equivalent to an accessory of the predicate device or another class I device?
4) Finally, is there any specific FDA guidance on mutual compatibility of different devices in a system? I believe there is something in Europe about it but I did not manage to find the same information for USA. 

I am aware that there is a guidance on accessories, but unfortunately I am not finding that very helpful and clear. 
Thanks in advance for your guidance

1) If there is no existing separate classification regulation for the accessory then the accessory has the same risk-based classification as the parent device. The FDA determines the level of regulatory control necessary for devices (and accessories), not the manufacturer. 

2) An accessory classification request is not mandatory.

3) The accessory should be included in the 510(k) of the parent device, but you should discuss with the FDA how you intend to demonstrate substantial equivalence.

Here's an example: My company recently received 510(k) clearance for an IVD. In order to measure the amount of analyte in the sample, an extraction step must be completed first. Our IVD includes a bottle of extraction buffer concentrate that can be used as part of a "manual weighing extraction process", but this extraction process is not ideal as it requires the end-user to weigh out the sample and add the correct amount of extraction buffer. In our submission we also included an alternative/optional "easy" extraction procedure that is completed using a product that we sell separately. For our submission we had to perform a comparison study to demonstrate that the same results can be obtained regardless of what extraction method was used. The same set of 60 samples had to be extracted using both the "manual weighing extraction process" and the "easy" extraction device, the extracts were subsequently analyzed using the IVD, and then the results were compared qualitatively and quantitatively.

------------------------------
Jeffrey Freedman
Regulatory Affairs Specialist II
Lowell MA
United States
------------------------------

Original Message:
Sent: 17-Mar-2020 05:44
From: Anonymous Member
Subject: class I accessory to class II parent device - FDA

This message was posted by a user wishing to remain anonymous

Hi all,
could you please provide guidance on how to proceed from a regulatory point of view with a class I accessory to a class II parent device?

1) Can the manufacturer autonomously decide that the accessory is a class I device based on risk analysis and simply apply design controls on it, without submitting pre-market documentation to the FDA?
2) Is the accessory classification request mandatory or just a recommendation? My understanding is that FDA treats this request as a Q-sub so it should be up to manufacturer to decide whether or not to discuss it with the FDA.
3) Shall the accessory still be included in the 510k of the parent device and proven to be substantial equivalent to an accessory of the predicate device or another class I device?
4) Finally, is there any specific FDA guidance on mutual compatibility of different devices in a system? I believe there is something in Europe about it but I did not manage to find the same information for USA.

I am aware that there is a guidance on accessories, but unfortunately I am not finding that very helpful and clear.
Thanks in advance for your guidance

This message was posted by a user wishing to remain anonymous

Thank you Jeffrey for your explanation.
Just a clarification:
What if there is an existing separate classification regulation available (class I and 510k exempt) for the accessory? should we still include include the accessory in our 510k and prove equivalence?
Thanks again
Original Message:
Sent: 19-Mar-2020 11:45
From: Jeffrey Freedman
Subject: class I accessory to class II parent device - FDA

1) If there is no existing separate classification regulation for the accessory then the accessory has the same risk-based classification as the parent device. The FDA determines the level of regulatory control necessary for devices (and accessories), not the manufacturer.

2) An accessory classification request is not mandatory.

3) The accessory should be included in the 510(k) of the parent device, but you should discuss with the FDA how you intend to demonstrate substantial equivalence.

Here's an example: My company recently received 510(k) clearance for an IVD. In order to measure the amount of analyte in the sample, an extraction step must be completed first. Our IVD includes a bottle of extraction buffer concentrate that can be used as part of a "manual weighing extraction process", but this extraction process is not ideal as it requires the end-user to weigh out the sample and add the correct amount of extraction buffer. In our submission we also included an alternative/optional "easy" extraction procedure that is completed using a product that we sell separately. For our submission we had to perform a comparison study to demonstrate that the same results can be obtained regardless of what extraction method was used. The same set of 60 samples had to be extracted using both the "manual weighing extraction process" and the "easy" extraction device, the extracts were subsequently analyzed using the IVD, and then the results were compared qualitatively and quantitatively.

------------------------------
Jeffrey Freedman
Regulatory Affairs Specialist II
Lowell MA
United States

Original Message:
Sent: 17-Mar-2020 05:44
From: Anonymous Member
Subject: class I accessory to class II parent device - FDA

This message was posted by a user wishing to remain anonymous

Hi all,
could you please provide guidance on how to proceed from a regulatory point of view with a class I accessory to a class II parent device?

1) Can the manufacturer autonomously decide that the accessory is a class I device based on risk analysis and simply apply design controls on it, without submitting pre-market documentation to the FDA?
2) Is the accessory classification request mandatory or just a recommendation? My understanding is that FDA treats this request as a Q-sub so it should be up to manufacturer to decide whether or not to discuss it with the FDA.
3) Shall the accessory still be included in the 510k of the parent device and proven to be substantial equivalent to an accessory of the predicate device or another class I device?
4) Finally, is there any specific FDA guidance on mutual compatibility of different devices in a system? I believe there is something in Europe about it but I did not manage to find the same information for USA.

I am aware that there is a guidance on accessories, but unfortunately I am not finding that very helpful and clear.
Thanks in advance for your guidance

This message was posted by a user wishing to remain anonymous

Hello all,
I hope somebody in the forum can provide some guidance on my questions above. As a follow-up question, I wonder how product regulations for class I devices are created, if often these devices are exempt from submitting pre-market documentation (e.g., 510k) to the FDA. This is somehow linked to question 1 of my previous post: whether the manufacturer can autonomously decide and classify the device without FDA's documentation review and authorization.
Thanks again. I hope somebody can help me understand a little more about class I accessories.
Original Message:
Sent: 17-Mar-2020 05:44
From: Anonymous Member
Subject: class I accessory to class II parent device - FDA

This message was posted by a user wishing to remain anonymous

Hi all,
could you please provide guidance on how to proceed from a regulatory point of view with a class I accessory to a class II parent device?

1) Can the manufacturer autonomously decide that the accessory is a class I device based on risk analysis and simply apply design controls on it, without submitting pre-market documentation to the FDA?
2) Is the accessory classification request mandatory or just a recommendation? My understanding is that FDA treats this request as a Q-sub so it should be up to manufacturer to decide whether or not to discuss it with the FDA.
3) Shall the accessory still be included in the 510k of the parent device and proven to be substantial equivalent to an accessory of the predicate device or another class I device?
4) Finally, is there any specific FDA guidance on mutual compatibility of different devices in a system? I believe there is something in Europe about it but I did not manage to find the same information for USA.

I am aware that there is a guidance on accessories, but unfortunately I am not finding that very helpful and clear.
Thanks in advance for your guidance