Regulatory Open Forum

If we show that our results are predictive of an important clinical outcome (e.g. patients who are treated based on a target produced by our product do not have surgical complications) do we still need to show equivalence to a predicate device?

It is my understanding for a 510(k) that we must always show substantial equivalence to a predicate device. However, it's also my understanding that we can have additional or different outcomes than our predicate and this is known as a 'technological difference'. If we V&V it and have the proper documentation, this should still suffice in our submission. Do you have a different understanding or experience?

Christa,

Luckily the equivalent device approach with US FDA has some flexibility in supporting safety and efficacy (performance) against a predicate device.  You must demonstrate equivalency, but if there are differences, these can be explained, justified, or provide rationale through some other method such as Verification and Validation (V&V) testing or comparative testing.  The simple answer is demonstrating equivalency can be shown in different ways, these just need to be substantiated through documentation, testing, or other information.  To provide further comments, would need to look at the specific devices, intended use, testing, etc., but this can be done.

If we show that our results are predictive of an important clinical outcome (e.g. patients who are treated based on a target produced by our product do not have surgical complications) do we still need to show equivalence to a predicate device?

It is my understanding for a 510(k) that we must always show substantial equivalence to a predicate device. However, it's also my understanding that we can have additional or different outcomes than our predicate and this is known as a 'technological difference'. If we V&V it and have the proper documentation, this should still suffice in our submission. Do you have a different understanding or experience?

If we show that our results are predictive of an important clinical outcome (e.g. patients who are treated based on a target produced by our product do not have surgical complications) do we still need to show equivalence to a predicate device?

It is my understanding for a 510(k) that we must always show substantial equivalence to a predicate device. However, it's also my understanding that we can have additional or different outcomes than our predicate and this is known as a 'technological difference'. If we V&V it and have the proper documentation, this should still suffice in our submission. Do you have a different understanding or experience?

Hi Christa

To me, it sounds like you can make a good case for additional clinical benefits compared to the predicate. Safety and effectiveness is evaluated in the context of clinical benefits and risks. Substantial equivalence does not mean "equal". Your device can have a different benefit-risk balance; equivalent or better. 

Main point is to be able to backup your claims with clinical evidence. Otherwise, it is all speculative!

Hope this helps.

Best regards

If we show that our results are predictive of an important clinical outcome (e.g. patients who are treated based on a target produced by our product do not have surgical complications) do we still need to show equivalence to a predicate device?

It is my understanding for a 510(k) that we must always show substantial equivalence to a predicate device. However, it's also my understanding that we can have additional or different outcomes than our predicate and this is known as a 'technological difference'. If we V&V it and have the proper documentation, this should still suffice in our submission. Do you have a different understanding or experience?