Regulatory Open Forum

Hello Everyone,

I've read through several discussions regarding what kind of 510k to submit when you have a device change but I have a different question on this topic.  We manufacture IVDs and have a device change to one of our products.  I am 99% sure the change requires a new 510(k) submission.  My question is, in the submission, do we use the unmodified device as the predicate?

Also, after the modified device has been cleared through the 510(k) process, can the unmodified device stay on the market?

Thank you for any guidance and advice!

Joy

The particular details of the change need to be considered in order to definitively answer your question.  But as a general rule, you should choose whichever predicate gives you the best chance of convincing FDA that the new version is "substantially equivalent".  The unmodified version of the device may or may not be the best candidate for this.

For example, if you've only made a change in the IVD performance characteristics (i.e., analytical sensitivity, specificity, precision, etc.), then your own unmodified version may be a good choice as predicate.  But if you've changed the intended use, then you would need to choose a different predicate.

Remember the basis of substantial equivalence:

• the same intended use and the same technological characteristics as the predicate;

OR                

• the same intended use and different technological characteristics, wherein the data submitted to FDA:
  • do not raise new questions of safety and effectiveness; and
  • demonstrate that the device is at least as safe and effective as the predicate.

For your last question: There is no statutory/regulatory prohibition against having both versions on the market at the same time. But certain factors could dictate otherwise. For example, if having both versions in the marketplace could lead to confusion, user errors, etc., then that would be a problem. Or if there were safety issues associated with the unmodified version, then that also could disqualify it from further marketing.  There could also be other reasons to avoid marketing both at the same time.

Hope this helps.

Hello Everyone,

I've read through several discussions regarding what kind of 510k to submit when you have a device change but I have a different question on this topic.  We manufacture IVDs and have a device change to one of our products.  I am 99% sure the change requires a new 510(k) submission.  My question is, in the submission, do we use the unmodified device as the predicate?

Also, after the modified device has been cleared through the 510(k) process, can the unmodified device stay on the market?

Thank you for any guidance and advice!

Joy

Thank you Kevin!  This helps.  Our modified device changes the method for semi-quantification. The intended use is the same and the technological characteristics are the same.  The reason for my original question is that for a previous 510(k) submission, we used one of our devices (510k cleared) as a predicate and FDA didn't like that.  They wanted us to compare to another company's product so my concern was that for this modified product, they would make us go to a competitor's product for comparison.  In our case, it is so much easier to compare to the unmodified product and in theory should show the best substantial equivalence

Thanks again for your input.  

Joy

The particular details of the change need to be considered in order to definitively answer your question.  But as a general rule, you should choose whichever predicate gives you the best chance of convincing FDA that the new version is "substantially equivalent".  The unmodified version of the device may or may not be the best candidate for this.

For example, if you've only made a change in the IVD performance characteristics (i.e., analytical sensitivity, specificity, precision, etc.), then your own unmodified version may be a good choice as predicate.  But if you've changed the intended use, then you would need to choose a different predicate.

Remember the basis of substantial equivalence:

• the same intended use and the same technological characteristics as the predicate;

OR                

• the same intended use and different technological characteristics, wherein the data submitted to FDA:
  • do not raise new questions of safety and effectiveness; and
  • demonstrate that the device is at least as safe and effective as the predicate.

For your last question: There is no statutory/regulatory prohibition against having both versions on the market at the same time. But certain factors could dictate otherwise. For example, if having both versions in the marketplace could lead to confusion, user errors, etc., then that would be a problem. Or if there were safety issues associated with the unmodified version, then that also could disqualify it from further marketing.  There could also be other reasons to avoid marketing both at the same time.

Hope this helps.

Hello Everyone,

I've read through several discussions regarding what kind of 510k to submit when you have a device change but I have a different question on this topic.  We manufacture IVDs and have a device change to one of our products.  I am 99% sure the change requires a new 510(k) submission.  My question is, in the submission, do we use the unmodified device as the predicate?

Also, after the modified device has been cleared through the 510(k) process, can the unmodified device stay on the market?

Thank you for any guidance and advice!

Joy

Thank you Kevin!  This helps.  Our modified device changes the method for semi-quantification. The intended use is the same and the technological characteristics are the same.  The reason for my original question is that for a previous 510(k) submission, we used one of our devices (510k cleared) as a predicate and FDA didn't like that.  They wanted us to compare to another company's product so my concern was that for this modified product, they would make us go to a competitor's product for comparison.  In our case, it is so much easier to compare to the unmodified product and in theory should show the best substantial equivalence

Thanks again for your input.  

Joy

Ginger,

The predicate device and subject device must have the same intended use, period.  There is no leeway on this critical U.S. statutory and regulatory requirement.  If devices have different intended uses, then they are not substantially equivalent.  Accordingly, there has never been any instance where FDA found a subject device and predicate device substantially equivalent when the devices had different intended uses. If the predicate doesn't have the same intended use as the subject, then a different predicate must be chosen.  The examples to which you referred were undoubtedly examples of different “indications for use”.

It appears that you are equating/confusing "intended use" with "indications for use".  You wouldn't be the first to do so, as FDA’s approach to this has not been one of its clearest campaigns. Although “intended use” and “indications for use” are related, they are fundamentally different, and they are handled absolutely differently by the Agency when reviewing a 510(k) notification.

Here are links to a couple FDA guidance documents that will help you better understand the vital differences between "intended use" and "indications for use":

http://www.fda.gov/downloads/MedicalDevices/.../UCM284443.pdf   [see Part IV.D., page 15]

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073945.pdf

Ginger,

The predicate device and subject device must have the same intended use, period.  There is no leeway on this critical U.S. statutory and regulatory requirement.  If devices have different intended uses, then they are not substantially equivalent.  Accordingly, there has never been any instance where FDA found a subject device and predicate device substantially equivalent when the devices had different intended uses. If the predicate doesn't have the same intended use as the subject, then a different predicate must be chosen.  The examples to which you referred were undoubtedly examples of different “indications for use”.

It appears that you are equating/confusing "intended use" with "indications for use".  You wouldn't be the first to do so, as FDA’s approach to this has not been one of its clearest campaigns. Although “intended use” and “indications for use” are related, they are fundamentally different, and they are handled absolutely differently by the Agency when reviewing a 510(k) notification.

Here are links to a couple FDA guidance documents that will help you better understand the vital differences between "intended use" and "indications for use":

http://www.fda.gov/downloads/MedicalDevices/.../UCM284443.pdf   [see Part IV.D., page 15]

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073945.pdf

Ginger,

Some participants in this Forum may not have the breadth of experience you have (I may even be one of them).  Would you be willing to tell us more about how to achieve substantial equivalence when the predicate device and subject device don't have the same intended use?

Thanks,

Kevin

Ginger,

Some participants in this Forum may not have the breadth of experience you have (I may even be one of them).  Would you be willing to tell us more about how to achieve substantial equivalence when the predicate device and subject device don't have the same intended use?

Thanks,

Kevin

My strong suggestion for everyone is that 510(k) Sponsors be careful to stay within statutory/regulatory boundaries until someone provides proper evidence showing how it's acceptable to do otherwise.  For the purposes of this discussion, one such boundary is:

• "...Under section 513(i) of the FD&C Act, FDA may only determine that a device is substantially equivalent to a predicate device if it has the same intended use..." - FDA

Nonetheless, different indications for use can be permissible as long as they don't create a new intended use.

The term "intended use" means the general purpose of the device or its function. This encompasses the indications for use. In contrast, “indications for use” [see 21 CFR 814.20(b)(3)(i)], means the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended.

In addition to the prior links I gave, here's a link to another FDA guidance that helps specifically with determining a device's particular intended use:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm082162.htm

Ginger,

Some participants in this Forum may not have the breadth of experience you have (I may even be one of them).  Would you be willing to tell us more about how to achieve substantial equivalence when the predicate device and subject device don't have the same intended use?

Thanks,

Kevin

Hello Everyone,

I've read through several discussions regarding what kind of 510k to submit when you have a device change but I have a different question on this topic.  We manufacture IVDs and have a device change to one of our products.  I am 99% sure the change requires a new 510(k) submission.  My question is, in the submission, do we use the unmodified device as the predicate?

Also, after the modified device has been cleared through the 510(k) process, can the unmodified device stay on the market?

Thank you for any guidance and advice!

Joy

Hello Everyone,

I've read through several discussions regarding what kind of 510k to submit when you have a device change but I have a different question on this topic.  We manufacture IVDs and have a device change to one of our products.  I am 99% sure the change requires a new 510(k) submission.  My question is, in the submission, do we use the unmodified device as the predicate?

Also, after the modified device has been cleared through the 510(k) process, can the unmodified device stay on the market?

Thank you for any guidance and advice!

Joy