Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi RA folks,

My question is regarding a 510(k) for an indication expansion whereby the legal manufacturer wants to get clearance for the additional conditions/uses already cleared for a Predicate device.

I was wondering whether to submit a new traditional 510(k) or to submit a special 510(k) for this scenario. The proposed labeling change does not add new risk or modify existing risks. There is no change to the device design. So, I was leaning towards submission of a special 510(k), however, my understanding is that in a special 510(k) the predicate device is the device which got cleared in the original Traditional 510(k) and predicate in a special 510(k) cannot be the device of another manufacturer. Thoughts?

Thanks in advance for any insights!

Hello Anon.

You will have to submit a Traditional 510(k). In a Special 510(k) submission, as you mention, the predicate must be your own 'unmodified' device. According to the Sep 2019 Special 510(k) guidance: "The Special 510(k) Program is intended to facilitate the submission, review, and clearance of a change to a manufacturer's own legally marketed predicate device ("existing device")". 

In addition, the guidance also states that a Special 510(k) is not appropriate: "When . . . FDA anticipates a review of complete test reports will be necessary to establish SE, such as: Changes to the indications for use that are supported by clinical, animal, or cadaver data".

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
------------------------------

Original Message:
Sent: 16-Mar-2020 07:55
From: Anonymous Member
Subject: Special 510(k)

This message was posted by a user wishing to remain anonymous

Hi RA folks,

My question is regarding a 510(k) for an indication expansion whereby the legal manufacturer wants to get clearance for the additional conditions/uses already cleared for a Predicate device.

I was wondering whether to submit a new traditional 510(k) or to submit a special 510(k) for this scenario. The proposed labeling change does not add new risk or modify existing risks. There is no change to the device design. So, I was leaning towards submission of a special 510(k), however, my understanding is that in a special 510(k) the predicate device is the device which got cleared in the original Traditional 510(k) and predicate in a special 510(k) cannot be the device of another manufacturer. Thoughts?

Thanks in advance for any insights!

Roger is correct, a Special 510(k) is only allowed on your own device (using your previous version device as the predicate) with no changes to indications for use or substantial technology changes.  A Special 510(k) is for use when there are new product line extensions that are significant, changing to a process say like sterilisation, or changes to the device say like materials.  If you are adding conditions of use for the predicate, it sounds like you are talking about another company's device, which already would not be allowed under the Special 510(k) - it has to be your own device.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 17-Mar-2020 06:30
From: Roger Gray
Subject: Special 510(k)

Hello Anon.

You will have to submit a Traditional 510(k). In a Special 510(k) submission, as you mention, the predicate must be your own 'unmodified' device. According to the Sep 2019 Special 510(k) guidance: "The Special 510(k) Program is intended to facilitate the submission, review, and clearance of a change to a manufacturer's own legally marketed predicate device ("existing device")".

In addition, the guidance also states that a Special 510(k) is not appropriate: "When . . . FDA anticipates a review of complete test reports will be necessary to establish SE, such as: Changes to the indications for use that are supported by clinical, animal, or cadaver data".

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 16-Mar-2020 07:55
From: Anonymous Member
Subject: Special 510(k)

This message was posted by a user wishing to remain anonymous

Hi RA folks,

My question is regarding a 510(k) for an indication expansion whereby the legal manufacturer wants to get clearance for the additional conditions/uses already cleared for a Predicate device.

I was wondering whether to submit a new traditional 510(k) or to submit a special 510(k) for this scenario. The proposed labeling change does not add new risk or modify existing risks. There is no change to the device design. So, I was leaning towards submission of a special 510(k), however, my understanding is that in a special 510(k) the predicate device is the device which got cleared in the original Traditional 510(k) and predicate in a special 510(k) cannot be the device of another manufacturer. Thoughts?

Thanks in advance for any insights!

Changes to the indications for use, especially those that are expanding uses or making them more specific, are not eligible for Special 510(k). Says so right in the 510(k) paradigm guidance.

Thus, for the situation you describe a traditional 510(k) should be submitted.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 16-Mar-2020 07:55
From: Anonymous Member
Subject: Special 510(k)

This message was posted by a user wishing to remain anonymous

Hi RA folks,

My question is regarding a 510(k) for an indication expansion whereby the legal manufacturer wants to get clearance for the additional conditions/uses already cleared for a Predicate device.

I was wondering whether to submit a new traditional 510(k) or to submit a special 510(k) for this scenario. The proposed labeling change does not add new risk or modify existing risks. There is no change to the device design. So, I was leaning towards submission of a special 510(k), however, my understanding is that in a special 510(k) the predicate device is the device which got cleared in the original Traditional 510(k) and predicate in a special 510(k) cannot be the device of another manufacturer. Thoughts?

Thanks in advance for any insights!