Regulatory Open Forum

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

Hi Dan,

• The three most common types of 510(k) are: Traditional, Special, and Abbreviated. If the subject device of a 510(k) notification is found to be NOT substantially equivalent (NSE), then the sponsor may have the option of pursuing premarket clearance nonetheless via a de novo 510(k). But sponsors may also elect to pursue the de novo approach proactively rather than reactively. So a “de novo 510(k)” could I supposed be considered as a fourth type, but a Traditional, for example, could ultimately become a de novo.

• When a sponsor assesses a change to determine if the change requires a new 510(k), it is important to remember that the basic purpose of the change assessment is not to decide if the changed version is substantially equivalent (SE). Instead, the basic purpose of the assessment is to determine if the changed version “could raise new questions of safety and effectiveness”. If so, then a new 510(k) is required, whereby FDA will decide if the changed version is still SE to a legally marketed predicate device. The reason this distinction is important is because deciding if a change raises new questions of safety and effectiveness is a fundamentally different task than deciding if a modified device is SE to a predicate device. Moreover, the change could very well "raise new questions of safety and effectiveness", yet still be found by FDA to be SE to a predicate device.  An example is when a non-sterile device is changed to a device labeled as "STERILE".

•  Despite the fact that FDA’s new paradigm guidance document uses the terminology “Special 510(k): Device Modification”, that is merely a coincidental use of terms. In actuality, any of the three types of 510(k)’s can be used for a modified device depending on certain factors germane to each particular 510(k) type. For example, the Special 510(k) route depends on a declaration of conformity with design controls. But since compliance with design controls may or may not be present, a sponsor might instead choose an Abbreviated 510(k), which is based on declaration(s) of conformity to recognized consensus standards. But if there isn’t enough conformity to recognized consensus standards, then the sponsor may instead elect to use a Traditional 510(k), where the actual data directly supporting the SE assertion are provided for Agency review.  In addition, there can be other strategic or operational reasons for choosing one type over another. 

Hope this helps,

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

Thank you very much; I appreciate your clarification on the types of 510(k).

If a manufacturer follows the logic and concludes a 510(k) submission is in order, the next question is which kind of 510(k) is most appropriate. This is an area in which I don’t feel comfortable, but I think it is an important decision for any manufacturer that implements the current guidance or is exploring the draft guidance documents in anticipation of their becoming final.

Regardless of the decision, document or a new 510(k), I also see linkages to Corrections and Removals in Part 806 and the final guidance document in that area.

Change evaluation also leads to decisions about a new DI and about changes to the ISO 14971:2007 risk management file.

Hi Dan,

• The three most common types of 510(k) are: Traditional, Special, and Abbreviated. If the subject device of a 510(k) notification is found to be NOT substantially equivalent (NSE), then the sponsor may have the option of pursuing premarket clearance nonetheless via a de novo 510(k). But sponsors may also elect to pursue the de novo approach proactively rather than reactively. So a “de novo 510(k)” could I supposed be considered as a fourth type, but a Traditional, for example, could ultimately become a de novo.

• When a sponsor assesses a change to determine if the change requires a new 510(k), it is important to remember that the basic purpose of the change assessment is not to decide if the changed version is substantially equivalent (SE). Instead, the basic purpose of the assessment is to determine if the changed version “could raise new questions of safety and effectiveness”. If so, then a new 510(k) is required, whereby FDA will decide if the changed version is still SE to a legally marketed predicate device. The reason this distinction is important is because deciding if a change raises new questions of safety and effectiveness is a fundamentally different task than deciding if a modified device is SE to a predicate device. Moreover, the change could very well "raise new questions of safety and effectiveness", yet still be found by FDA to be SE to a predicate device.  An example is when a non-sterile device is changed to a device labeled as "STERILE".

•  Despite the fact that FDA’s new paradigm guidance document uses the terminology “Special 510(k): Device Modification”, that is merely a coincidental use of terms. In actuality, any of the three types of 510(k)’s can be used for a modified device depending on certain factors germane to each particular 510(k) type. For example, the Special 510(k) route depends on a declaration of conformity with design controls. But since compliance with design controls may or may not be present, a sponsor might instead choose an Abbreviated 510(k), which is based on declaration(s) of conformity to recognized consensus standards. But if there isn’t enough conformity to recognized consensus standards, then the sponsor may instead elect to use a Traditional 510(k), where the actual data directly supporting the SE assertion are provided for Agency review.  In addition, there can be other strategic or operational reasons for choosing one type over another. 

Hope this helps,

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

Nice summary Dan. However, I do not see the De Novo process as a fourth type of 510(k). It is simply a process to determine whether FDA considers the device as Class II (or I), allowing you to follow the 510(k) route. This is versus Class III which requires the pre-market approval (PMA) route.

Regardless of when you embark on the De Novo process, if FDA agrees to a Class II (or I) designation you must complete a traditional 510(K) unless the determination puts the device in an existing product regulation category, thus potentially allowing the possibility for an Abbreviated or Special 510(k) if you are modifying a device with an existing 510(k). This non-traditional De Novo 510(k) scenario, rarely, if ever, happens (I'd like to solicit feedback from others on this). In the end, you only have the three 510(k) routes. 

Thank you very much; I appreciate your clarification on the types of 510(k).

If a manufacturer follows the logic and concludes a 510(k) submission is in order, the next question is which kind of 510(k) is most appropriate. This is an area in which I don’t feel comfortable, but I think it is an important decision for any manufacturer that implements the current guidance or is exploring the draft guidance documents in anticipation of their becoming final.

Regardless of the decision, document or a new 510(k), I also see linkages to Corrections and Removals in Part 806 and the final guidance document in that area.

Change evaluation also leads to decisions about a new DI and about changes to the ISO 14971:2007 risk management file.

Hi Dan,

• The three most common types of 510(k) are: Traditional, Special, and Abbreviated. If the subject device of a 510(k) notification is found to be NOT substantially equivalent (NSE), then the sponsor may have the option of pursuing premarket clearance nonetheless via a de novo 510(k). But sponsors may also elect to pursue the de novo approach proactively rather than reactively. So a “de novo 510(k)” could I supposed be considered as a fourth type, but a Traditional, for example, could ultimately become a de novo.

• When a sponsor assesses a change to determine if the change requires a new 510(k), it is important to remember that the basic purpose of the change assessment is not to decide if the changed version is substantially equivalent (SE). Instead, the basic purpose of the assessment is to determine if the changed version “could raise new questions of safety and effectiveness”. If so, then a new 510(k) is required, whereby FDA will decide if the changed version is still SE to a legally marketed predicate device. The reason this distinction is important is because deciding if a change raises new questions of safety and effectiveness is a fundamentally different task than deciding if a modified device is SE to a predicate device. Moreover, the change could very well "raise new questions of safety and effectiveness", yet still be found by FDA to be SE to a predicate device.  An example is when a non-sterile device is changed to a device labeled as "STERILE".

•  Despite the fact that FDA’s new paradigm guidance document uses the terminology “Special 510(k): Device Modification”, that is merely a coincidental use of terms. In actuality, any of the three types of 510(k)’s can be used for a modified device depending on certain factors germane to each particular 510(k) type. For example, the Special 510(k) route depends on a declaration of conformity with design controls. But since compliance with design controls may or may not be present, a sponsor might instead choose an Abbreviated 510(k), which is based on declaration(s) of conformity to recognized consensus standards. But if there isn’t enough conformity to recognized consensus standards, then the sponsor may instead elect to use a Traditional 510(k), where the actual data directly supporting the SE assertion are provided for Agency review.  In addition, there can be other strategic or operational reasons for choosing one type over another. 

Hope this helps,

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

Thank you very much; I appreciate your clarification on the types of 510(k).

If a manufacturer follows the logic and concludes a 510(k) submission is in order, the next question is which kind of 510(k) is most appropriate. This is an area in which I don’t feel comfortable, but I think it is an important decision for any manufacturer that implements the current guidance or is exploring the draft guidance documents in anticipation of their becoming final.

Regardless of the decision, document or a new 510(k), I also see linkages to Corrections and Removals in Part 806 and the final guidance document in that area.

Change evaluation also leads to decisions about a new DI and about changes to the ISO 14971:2007 risk management file.

Hi Dan,

• The three most common types of 510(k) are: Traditional, Special, and Abbreviated. If the subject device of a 510(k) notification is found to be NOT substantially equivalent (NSE), then the sponsor may have the option of pursuing premarket clearance nonetheless via a de novo 510(k). But sponsors may also elect to pursue the de novo approach proactively rather than reactively. So a “de novo 510(k)” could I supposed be considered as a fourth type, but a Traditional, for example, could ultimately become a de novo.

• When a sponsor assesses a change to determine if the change requires a new 510(k), it is important to remember that the basic purpose of the change assessment is not to decide if the changed version is substantially equivalent (SE). Instead, the basic purpose of the assessment is to determine if the changed version “could raise new questions of safety and effectiveness”. If so, then a new 510(k) is required, whereby FDA will decide if the changed version is still SE to a legally marketed predicate device. The reason this distinction is important is because deciding if a change raises new questions of safety and effectiveness is a fundamentally different task than deciding if a modified device is SE to a predicate device. Moreover, the change could very well "raise new questions of safety and effectiveness", yet still be found by FDA to be SE to a predicate device.  An example is when a non-sterile device is changed to a device labeled as "STERILE".

•  Despite the fact that FDA’s new paradigm guidance document uses the terminology “Special 510(k): Device Modification”, that is merely a coincidental use of terms. In actuality, any of the three types of 510(k)’s can be used for a modified device depending on certain factors germane to each particular 510(k) type. For example, the Special 510(k) route depends on a declaration of conformity with design controls. But since compliance with design controls may or may not be present, a sponsor might instead choose an Abbreviated 510(k), which is based on declaration(s) of conformity to recognized consensus standards. But if there isn’t enough conformity to recognized consensus standards, then the sponsor may instead elect to use a Traditional 510(k), where the actual data directly supporting the SE assertion are provided for Agency review.  In addition, there can be other strategic or operational reasons for choosing one type over another. 

Hope this helps,

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

I was going to share my opinion, but Kevin said it all. I believe that Kevin's answer will be very helpful to you, as he mentioned, the basic purpose of the assessment is to determine if the changed version “could raise new questions of safety and effectiveness”.

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

I am sure that you might know about these two FDA guidance already, but in case that you don't, these two Guidance are very helpful

Deciding When to Submit a 510(k) for a Change to an Existing Device

Deciding When to Submit a 510(k) for a Software Change to an Existing Device

I was going to share my opinion, but Kevin said it all. I believe that Kevin's answer will be very helpful to you, as he mentioned, the basic purpose of the assessment is to determine if the changed version “could raise new questions of safety and effectiveness”.

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

I am sure that you might know about these two FDA guidance already, but in case that you don't, these two Guidance are very helpful

Deciding When to Submit a 510(k) for a Change to an Existing Device

Deciding When to Submit a 510(k) for a Software Change to an Existing Device

Mark, was this a published opinion?  I would be interested to read it.

Also, what was the client's relative ROI here, litigation time and cost versus the time and cost of filing a 510(k) for the labeling change?

Mark may be referring to this article. It's a bit lengthy, but quite fascinating read.

http://www.massdevice.com/legalization-off-label-promotion-vascular-solutions-beat-fda-victory-means-medtech/

Mark, was this a published opinion?  I would be interested to read it.

Also, what was the client's relative ROI here, litigation time and cost versus the time and cost of filing a 510(k) for the labeling change?

Mark, was this a published opinion?  I would be interested to read it.

Also, what was the client's relative ROI here, litigation time and cost versus the time and cost of filing a 510(k) for the labeling change?

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

Hi Dan, 

As has been alluded to, the assessment of whether a modification needs a new 510(k), and the type of 510(k) submission needed can be seen as two independent things.

It is not necessary that a change to an existing device autimatically means a special 510(k) is warranted. There are basic rules for determining what type of 510(k) can be used for any 510(k) submission, whether or not it is the result of a device modification. The rules are below: 

Special 510(k) - A special 510(k) us warranted for modification to an existing device where the modification (1) does not change intended use; and (2) does not involve a change in fundamental scientific technology (in some guidance, fundamental scientific technology amounts to operating principle or control mechanism). As long as both these conditions are true, a special 510(k) may be used. Otherwise, it would need to be a traditional or abbreviated. So, while it is true that a special 510(k) is only applicable for a device modification, not all device modifications are eligible for the special 510(k) route.

Abbreviated 510(k) - This could be used for a new device or for a device modification. It is warranted when there are established FDA recognized performance standards (an example is IEC 60601-2-41 for surgical lights). in this case, a manufacturer can declare conformity to the performance standard and be able to do an abbreviated 510(k), relying on the standrd for performance data. 

Traditional 510(k) - this is generally applicable for a brand new device for which there are no FDA recognized performance standards or for a device modification which does not fall into the special 510(k) criteria.

Regarding De-novo, this is essentially for novel devices have no predicate (automatic clasa III) but a manufacturer beleives it does not pose a high risk to warrant a PMA. 

Hope this helps! 

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

I don’t work in the 510(k) preparation area, only the aftermath. Consequently, I have a basic question. As I understand the situation, there are three kinds of 510(k): Regular, Special, and De novo.

Assume a manufacturer follows the process to determine if a device change or modification requires a new 510(k). The manufacturer expects that the device after the change or modification is substantially equivalent to the device before the modification.

I believe the proper vehicle, in this case, is the Special 510(k) and the predicate device is the manufacturer’s device as most recently cleared.

Could somebody confirm this? If not, please point me in the right direction.

Thanks to all of you who provided information. This has certainly clarified the situation for me.

I appreciate your taking the time.

David, I must disagree.  I don't think the De novo process is a "510(k) program" at all.  Kevin notes that the De novo comes from a different section of the Act, 510(j), but perhaps the attorney in the room (Mark?) can quote us final chapter and verse on this. 

I think a device might or might not go through the 510(k) process in advance of the De novo process,  but once it is determined to be NSE, it leaves the 510(k) behind and enters into a completely different process.

Julie, you're right in that the De Novo petition is not the same as 510(k), but it is more similar to a 510(k) submission than any other submission, and in a sense it's an extension of the 510(k). Most of the content from a 510(k) submission applies to the De Novo, especially if it contained the clinical data.

The process is not so much different either, in my opinion, with the exception of creating the new classification by the agency.

You submit paper and e-copy, which may be rejected. Then you may get a few administrative or clarification questions before the substantive review begins. During the substantive review you will likely receive a request for additional information (also called deficiency letter). Next you enter an interactive phase where additional questions or data, or requests for changes may be made.

Finally you get the decision, which consists of two parts: the device clearance, and the new device classification.

At least that's what my experience was. I submitted after the draft guidance of 2014. It took just over a year to get the clearance (came through yesterday); not including a withdrawn 510(k) submission.

As you may know, there was another De Novo guidance released in 2011, and for the most part it's similar to the more recent once with the exception of the direct De Novo route. In the older guidance, the agency described a "Post-PDS Concurrent 510(k)/De Novo Petition", which seems to be a precursor to the current direct De Novo route. 

David, I must disagree.  I don't think the De novo process is a "510(k) program" at all.  Kevin notes that the De novo comes from a different section of the Act, 510(j), but perhaps the attorney in the room (Mark?) can quote us final chapter and verse on this. 

I think a device might or might not go through the 510(k) process in advance of the De novo process,  but once it is determined to be NSE, it leaves the 510(k) behind and enters into a completely different process.

David, I must disagree.  I don't think the De novo process is a "510(k) program" at all.  Kevin notes that the De novo comes from a different section of the Act, 510(j), but perhaps the attorney in the room (Mark?) can quote us final chapter and verse on this. 

I think a device might or might not go through the 510(k) process in advance of the De novo process,  but once it is determined to be NSE, it leaves the 510(k) behind and enters into a completely different process.

David, I must disagree.  I don't think the De novo process is a "510(k) program" at all.  Kevin notes that the De novo comes from a different section of the Act, 510(j), but perhaps the attorney in the room (Mark?) can quote us final chapter and verse on this. 

I think a device might or might not go through the 510(k) process in advance of the De novo process,  but once it is determined to be NSE, it leaves the 510(k) behind and enters into a completely different process.

David, I must disagree.  I don't think the De novo process is a "510(k) program" at all.  Kevin notes that the De novo comes from a different section of the Act, 510(j), but perhaps the attorney in the room (Mark?) can quote us final chapter and verse on this. 

I think a device might or might not go through the 510(k) process in advance of the De novo process,  but once it is determined to be NSE, it leaves the 510(k) behind and enters into a completely different process.