Regulatory Open Forum

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.

It is up to the firm as it is part of their business decision whether to push back at least once (with compelling argument) or go with the de novo.  Most times, FDA wins!

What is important is the following when a firm determines there is no suitable predicate from FDA perspectives.

First with full awareness regarding de novo process under FDASIA, a firm should decide which process to take.

1). With a pre-sub done, submit a 510(k) with de novo request simultaneously. Separate fee payment applies.

OR

2). Without a pre-sub done, submit a 510(k) first and present with all possible argument (scientifically sound and clinically meaningful argument). 

If successful, the 510(k) gets cleared. If not, get an NSE letter and then file a de novo petition within 30 days!

A good assessment on each case is critical.

You are welcome to go through me and I can provide my assessment, most of my various types of assessments* have turned out to be on points in good alignment with the FDA's final decision.
*: it includes, but not limited to, 510(k) review and assessment.

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?

1. NSE's are definitely not dead. You can absolutely get NSE for lack of performance data, new questions of intended use, etc. 
2. I think a good reason for FDA not publishing NSEs are IP concerns. NSE's can still come back and attempt clearance again under 510(k) or de novo when more evidence is available. An NSE can be considered a product still in development, therefore, the FDA shouldn't be publishing anything about it.

Has anyone had any recent experience dealing with a 510(k) that was not "straightforward" (heh), so that you needed to try to assess the odds that FDA would accept the argument for SE?

In my experience (startups), if there is a reasonable chance that the claim of SE will be accepted, the company will decided to move forward with a 510(k) to resolve the question, without pursuing a pre-sub or 513(g) determination.

What I'm interested in is what happens (and when) if the FDA decides it should be a De novo.  If that decision doesn't come until the full review has been completed, then it seems to me that, for all practical purposes, FDASIA will have, for the most part, taken a 5-year detour to bring us back to where we started, with most NSE devices going through an "indirect" De novo process.

Does anyone know if this is what is happening?  If it isn't, then what?

Also, does anyone know what this means in terms of user fees?  Does the applicant have to pay both the 510(k) filing fee and the De novo fee?

Finally, everyone has been inclined to think that, with the direct De novo option now available, FDA would become less flexible in its SE determinations.  Has anyone here seen this as a trend?