Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear network, 

I am looking for the right terminology to explain what action FDA are performing when they review the labelling within a 510k. 

I am clear on the 510k clearance aspect, in that the 510k process is to demonstrate that the device is as safe and effective as the legally marketed device. Also, that a new 510k would be required in instances whereby labeling is changed with impact on indications for use (etc.). 

What I am struggling with is device claims (for example, an accuracy claim) on the device labeling. My understanding as part of the clearance is that the labeling is reviewed from a safety and performance perspective, but are FDA 'approving' (clearing) marketing claims or performance claims such as accuracy?

When FDA reviews a 510(k) and the proposed labeling therein and issues a substantial equivalence finding, then the reviewed labeling is generally referred to as "510(k)-cleared" labeling as a matter of general fact.  Yet as an aside, be sure not to subsequently violate FDA's Part 807 prohibitions against any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations, as that is deemed by FDA to be misleading and constitutes misbranding.

Your ultimate question can be a touchy topic.  This is because FDA requires that the 510(k) include the proposed labeling and advertisements sufficient to describe the device, its intended use, and the directions for its use.

In order to avoid having to include a proposed labeled accuracy claim in the 510(k), then one would need to be able to justify that such a proposed labeling claim isn't needed for describing the device, its intended use, and the directions for its use.  But such an argument can get pretty dicey pretty quick for something like an accuracy claim, as such a claim could be quite germane to the indications for use, which is a sub-tier under the intended use.

On the other hand, clients often WANT FDA's blessing for some provocative, edgy advertising claim, and so will be sure to include it in the 510(k) in order to get clearance for that claim.

So, your firm's overall motives for the claim with respect to FDA clearance will affect your course of action.

One thing to keep in mind is that, in practice, if no advertising has yet been proposed, then no advertising needs to be included in the 510(k).  Indeed, 510(k) clearance isn't generally contingent on provision of such advertising.  However, for certain technologies, FDA might in theory call for the advertising during the 510(k) review, though I've not ever seen that before in a 510(k).

What can get risky for a firm is if it has proposed advertising but then doesn't include it in the 510(k).  That could be viewed by FDA as misleading and fraudulent.  Yet such a situation wouldn't generally arise and blow up unless a serious public health issue was caused by the advertising claim and then FDA somehow made its way back to discovering that the claim was wrongly omitted from the 510(k).  Again, such a theoretical scenario is highly unlikely to occur, and I've never seen such a scenario come to pass.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 26-Oct-2022 02:55
From: Anonymous Member
Subject: 510k Labelling 'clearance'/'approval'

This message was posted by a user wishing to remain anonymous

Dear network,

I am looking for the right terminology to explain what action FDA are performing when they review the labelling within a 510k.

I am clear on the 510k clearance aspect, in that the 510k process is to demonstrate that the device is as safe and effective as the legally marketed device. Also, that a new 510k would be required in instances whereby labeling is changed with impact on indications for use (etc.).

What I am struggling with is device claims (for example, an accuracy claim) on the device labeling. My understanding as part of the clearance is that the labeling is reviewed from a safety and performance perspective, but are FDA 'approving' (clearing) marketing claims or performance claims such as accuracy?

When I was legal counsel at a device manufacturer, they made it a best practice to include key claims as an optional/voluntary part of the submission, especially what we used to call "clinical-sounding technical claims" that were comparative in nature but were shown to be true with supporting test results.   

It was a big success as having the content in the submission gave the ad/prom review team confidence that the content was defensible, rather than the traditional approach of zero promotional materials as they are not technically required.    In my opinion, part of the grey area that Kevin Randall nicely explained in his response is due to the fact that this issue varies widely between Class II/III and even more when compared to drugs/biologics.   

On the non-generic drug side, one files promotional content before (e.g., accelerated approval) or upon first use on 2253, and like drugs, Class III requires clinical data, which substantiates promo claims.   For Class II, however, it's more of an 'honor' system as nothing is filed and I'd recommend including a claims sheet with supporting proof in your submission for whatever key claims everyone agrees will be used after clearance.   Whatever you include will help everyone after clearance as you review power point slides and debate whether a promotional claim that the commercial team wants to use is ok, especially if it seems like a comparative or superiority claim.

------------------------------
Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361
------------------------------

Original Message:
Sent: 26-Oct-2022 02:55
From: Anonymous Member
Subject: 510k Labelling 'clearance'/'approval'

This message was posted by a user wishing to remain anonymous

Dear network,

I am looking for the right terminology to explain what action FDA are performing when they review the labelling within a 510k.

I am clear on the 510k clearance aspect, in that the 510k process is to demonstrate that the device is as safe and effective as the legally marketed device. Also, that a new 510k would be required in instances whereby labeling is changed with impact on indications for use (etc.).

What I am struggling with is device claims (for example, an accuracy claim) on the device labeling. My understanding as part of the clearance is that the labeling is reviewed from a safety and performance perspective, but are FDA 'approving' (clearing) marketing claims or performance claims such as accuracy?

This message was posted by a user wishing to remain anonymous

Not to open a new topic, but I have a question.

If you submit your proposed labeling for the 510(k), including the user guide, manuals, and brochure, what are the criteria for the update without having to submit a new 510(k)?

I see the obvious ones, such as changing the intended use or the described technology, but changing the visual layout of the brochure would not constitute such a change. Or making enhancements to the existing product, without impacting the cleared safety and effectiveness, which results in updating the user guide.

Do you have any other examples or stories to share?

Original Message:
Sent: 27-Oct-2022 10:38
From: Roger Cepeda
Subject: 510k Labelling 'clearance'/'approval'

When I was legal counsel at a device manufacturer, they made it a best practice to include key claims as an optional/voluntary part of the submission, especially what we used to call "clinical-sounding technical claims" that were comparative in nature but were shown to be true with supporting test results.   

It was a big success as having the content in the submission gave the ad/prom review team confidence that the content was defensible, rather than the traditional approach of zero promotional materials as they are not technically required.    In my opinion, part of the grey area that Kevin Randall nicely explained in his response is due to the fact that this issue varies widely between Class II/III and even more when compared to drugs/biologics.   

On the non-generic drug side, one files promotional content before (e.g., accelerated approval) or upon first use on 2253, and like drugs, Class III requires clinical data, which substantiates promo claims.   For Class II, however, it's more of an 'honor' system as nothing is filed and I'd recommend including a claims sheet with supporting proof in your submission for whatever key claims everyone agrees will be used after clearance.   Whatever you include will help everyone after clearance as you review power point slides and debate whether a promotional claim that the commercial team wants to use is ok, especially if it seems like a comparative or superiority claim.

------------------------------
Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361

Original Message:
Sent: 26-Oct-2022 02:55
From: Anonymous Member
Subject: 510k Labelling 'clearance'/'approval'

This message was posted by a user wishing to remain anonymous

Dear network,

I am looking for the right terminology to explain what action FDA are performing when they review the labelling within a 510k.

I am clear on the 510k clearance aspect, in that the 510k process is to demonstrate that the device is as safe and effective as the legally marketed device. Also, that a new 510k would be required in instances whereby labeling is changed with impact on indications for use (etc.).

What I am struggling with is device claims (for example, an accuracy claim) on the device labeling. My understanding as part of the clearance is that the labeling is reviewed from a safety and performance perspective, but are FDA 'approving' (clearing) marketing claims or performance claims such as accuracy?