Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

510K cleared products are cleared as being "Substantially Equivalent" to a predicate device. Would this preclude a company from promoting observational information that demonstrates superiority to the predicate device? Ultimately would claiming superiority misbrand your device?

Any thoughts would be appreciated!

you are correct. Claiming superior cant be done by 510k clearance decision. Technically proving superiority Done with a study powered for the statistics to make that claim. I would avoid those kinds of terms while presenting the data that you have to allow the reader to come to the conclusion themselves.

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Sarah Parsons RAC
Director Regulatory Affairs, Diagnostics
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Original Message:
Sent: 07-Jul-2023 09:19
From: Anonymous Member
Subject: 510K Device Comparison Promotion Vs. Predicate Device

This message was posted by a user wishing to remain anonymous

510K cleared products are cleared as being "Substantially Equivalent" to a predicate device. Would this preclude a company from promoting observational information that demonstrates superiority to the predicate device? Ultimately would claiming superiority misbrand your device?

Any thoughts would be appreciated!

You can't claim superiority to the predicate device unless you have performed a well controlled study to demonstrate this and FDA agrees.  It is not easy to prove superiority for a product, regardless of the type of approval.

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Michael Hamrell, Ph.D., FRAPS, RAC, FRAPS
Nipomo CA
United States
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Original Message:
Sent: 07-Jul-2023 09:19
From: Anonymous Member
Subject: 510K Device Comparison Promotion Vs. Predicate Device

This message was posted by a user wishing to remain anonymous

510K cleared products are cleared as being "Substantially Equivalent" to a predicate device. Would this preclude a company from promoting observational information that demonstrates superiority to the predicate device? Ultimately would claiming superiority misbrand your device?

Any thoughts would be appreciated!

And if you do have superiority, then no, it doesn't have to constitute misbranding. "Substantial equivalence" doesn't mean it's identical.

From 21 CFR 807.92 on demonstrating equivalence, "(3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section."

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Anne LeBlanc
United States
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Original Message:
Sent: 08-Jul-2023 16:20
From: Michael Hamrell
Subject: 510K Device Comparison Promotion Vs. Predicate Device

You can't claim superiority to the predicate device unless you have performed a well controlled study to demonstrate this and FDA agrees.  It is not easy to prove superiority for a product, regardless of the type of approval.

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Michael Hamrell, Ph.D., FRAPS, RAC, FRAPS
Nipomo CA
United States

Original Message:
Sent: 07-Jul-2023 09:19
From: Anonymous Member
Subject: 510K Device Comparison Promotion Vs. Predicate Device

This message was posted by a user wishing to remain anonymous

510K cleared products are cleared as being "Substantially Equivalent" to a predicate device. Would this preclude a company from promoting observational information that demonstrates superiority to the predicate device? Ultimately would claiming superiority misbrand your device?

Any thoughts would be appreciated!

Dear Anon,

You have received some good responses to your question, but they remain somewhat divided. I believe that your use of the term superiority has engendered some of the confusion.  As stated by some of the respondents, substantial equivalence does not a device cannot be better than the predicate.  In fact, the 510(k) process has always been used to advance the technology, features and functions of devices as compared to their predicate device.  Your device nay have features that add significant value and make it clearly better or "superior" to the predicate device.  Your device may be easier to use which can produce the same effect.

I believe the confusion is the use of the term "superior" which seems tube a term of art for clinical comparisons.  There are many clinical studies that show non-inferiority or superiority for a clinical benefit, effect, adverse event, etc.  If you are speaking about superiority as demonstrated by a clinical study (which are not usually required for 510(k) clearance), then you should certainly have that data to back up your claim.  It does not make you device not substantially equivalent and not make your device misbranded.

The use of the generic term superior to mean better, prettier, easier, or with more features that are desirable, is a marketing claim that if worded correctly can be more a statement of fact then an actual claim. For example, "T use this device only requires one step to make it ready to use, unlike competitive devices that require multiple step before it is ready." or the product has a glow in the dark display that makes it easier to see at night without use of a light.   There are a multitude of things that could make one device "better' or "superior" to the predicate without making it non-substantially equivalen, or requiring a new submission, or even requiring a study.

If you clarify whether the difference is from a clinical study, or a "better than" derived comparison, that may help you get a more definitive answer.

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Lee Leichter RAC
President
Fort Denaud FL
United States
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Original Message:
Sent: 07-Jul-2023 09:19
From: Anonymous Member
Subject: 510K Device Comparison Promotion Vs. Predicate Device

This message was posted by a user wishing to remain anonymous

510K cleared products are cleared as being "Substantially Equivalent" to a predicate device. Would this preclude a company from promoting observational information that demonstrates superiority to the predicate device? Ultimately would claiming superiority misbrand your device?

Any thoughts would be appreciated!

Hello Anon,

To add some further thought: claiming superiority to a predicate device or even a competitive device really depends on the indications for use and the claim which is being made.  As an example, a study which shows a device processes something faster or allows faster response may or may not cross this superiority.  However, a study where the device shows a better superiority in another disease state may not be within the indications for use - or passing a line over the indications for use.  Personally what I have seen is companies sometimes push the envelope a bit, depending on the device type.  There can be a fine line between safety and efficacy of a device and advertising.  It would probably be recommended to have an expert review the objectives of this observational study to determine whether this falls under the 8xx.9 limitation of exemption (going outside the regulation intended use) or may really just show the device performs better in some characteristic.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Jul-2023 08:12
From: Lee Leichter
Subject: 510K Device Comparison Promotion Vs. Predicate Device

Dear Anon,

You have received some good responses to your question, but they remain somewhat divided. I believe that your use of the term superiority has engendered some of the confusion.  As stated by some of the respondents, substantial equivalence does not a device cannot be better than the predicate.  In fact, the 510(k) process has always been used to advance the technology, features and functions of devices as compared to their predicate device.  Your device nay have features that add significant value and make it clearly better or "superior" to the predicate device.  Your device may be easier to use which can produce the same effect.

I believe the confusion is the use of the term "superior" which seems tube a term of art for clinical comparisons.  There are many clinical studies that show non-inferiority or superiority for a clinical benefit, effect, adverse event, etc.  If you are speaking about superiority as demonstrated by a clinical study (which are not usually required for 510(k) clearance), then you should certainly have that data to back up your claim.  It does not make you device not substantially equivalent and not make your device misbranded.

The use of the generic term superior to mean better, prettier, easier, or with more features that are desirable, is a marketing claim that if worded correctly can be more a statement of fact then an actual claim. For example, "T use this device only requires one step to make it ready to use, unlike competitive devices that require multiple step before it is ready." or the product has a glow in the dark display that makes it easier to see at night without use of a light.   There are a multitude of things that could make one device "better' or "superior" to the predicate without making it non-substantially equivalen, or requiring a new submission, or even requiring a study.

If you clarify whether the difference is from a clinical study, or a "better than" derived comparison, that may help you get a more definitive answer.

------------------------------
Lee Leichter RAC
President
Fort Denaud FL
United States

Original Message:
Sent: 07-Jul-2023 09:19
From: Anonymous Member
Subject: 510K Device Comparison Promotion Vs. Predicate Device

This message was posted by a user wishing to remain anonymous

510K cleared products are cleared as being "Substantially Equivalent" to a predicate device. Would this preclude a company from promoting observational information that demonstrates superiority to the predicate device? Ultimately would claiming superiority misbrand your device?

Any thoughts would be appreciated!

Anonymous,

I hope you are doing well.  Here are some preliminary thoughts.  

o  FDA considers comparative/superiority claims inherently misleading unless based on appropriate head-to-head testing.

§  21 CFR Part 801: Labeling. Subpart A: General Labeling Provisions. Sec. 801.6 Medical Devices Misleading Statements. "Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic." Even where a company is comparing to a prior version of its own device, head-to-head supportive testing should be provided. Typically, such testing must be reviewed by FDA prior to serving as a basis for claims.

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William Coulston PMP, MS, RAC
Director of Quality & Regulatory Affairs
San Antonio TX
United States
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Original Message:
Sent: 07-Jul-2023 09:19
From: Anonymous Member
Subject: 510K Device Comparison Promotion Vs. Predicate Device

This message was posted by a user wishing to remain anonymous

510K cleared products are cleared as being "Substantially Equivalent" to a predicate device. Would this preclude a company from promoting observational information that demonstrates superiority to the predicate device? Ultimately would claiming superiority misbrand your device?

Any thoughts would be appreciated!

Hi, superiority claim can be done during the 510k submission by doing appropriate performance testing and getting the relevant data reviewed and approved. Otherwise, it will be deemed misbranding. .

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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
------------------------------

Original Message:
Sent: 07-Jul-2023 09:19
From: Anonymous Member
Subject: 510K Device Comparison Promotion Vs. Predicate Device

This message was posted by a user wishing to remain anonymous

510K cleared products are cleared as being "Substantially Equivalent" to a predicate device. Would this preclude a company from promoting observational information that demonstrates superiority to the predicate device? Ultimately would claiming superiority misbrand your device?

Any thoughts would be appreciated!

Claiming superiority over a predicate device could potentially be seen as misbranding, as it might imply a different intended use or different technological characteristics that were not evaluated during the 510(k) clearance process.

However, observational information that demonstrates superiority to the predicate device could potentially be used in marketing materials, provided that it does not contradict or go beyond the cleared intended use or technological characteristics of the device. Any such claims would need to be supported by appropriate evidence and should not be misleading.

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John Zachary
Orca1 DI
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Original Message:
Sent: 07-Jul-2023 09:19
From: Anonymous Member
Subject: 510K Device Comparison Promotion Vs. Predicate Device

This message was posted by a user wishing to remain anonymous

510K cleared products are cleared as being "Substantially Equivalent" to a predicate device. Would this preclude a company from promoting observational information that demonstrates superiority to the predicate device? Ultimately would claiming superiority misbrand your device?

Any thoughts would be appreciated!

Hello

Very interesting question and discussion!

I agree that the term "superior" is leading to a lot of confusion. Superior to what and in what way?

If the "superiority" claims appear to give an impression the device could reasonably be used outside of the intended use/indication, then surely it will lead to a determination of "misbranded". I have seen many warning letters to this effect where marketing claims are judged to be outside the authorized use. 

Another point to consider - if the "superiority" claim points to a new technological characteristic not evaluated by the FDA in the original 510k, then you should review if a new 510k is warranted. If not, again, the device would be considered "misbranded".

Take a step back - ask if the "superior" claim could in any way impact the initial assessment of safety and effectiveness (Benefit-Risk). If so, review if a new 510k is warranted. Document your decision with a good analysis and justification. 

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Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
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Original Message:
Sent: 07-Jul-2023 09:19
From: Anonymous Member
Subject: 510K Device Comparison Promotion Vs. Predicate Device

This message was posted by a user wishing to remain anonymous

510K cleared products are cleared as being "Substantially Equivalent" to a predicate device. Would this preclude a company from promoting observational information that demonstrates superiority to the predicate device? Ultimately would claiming superiority misbrand your device?

Any thoughts would be appreciated!