Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello Anon,

I understand your dilemma, in the same situation.  We submitted a 513(g) on 18 September and still have not heard anything.  In the current state of the world, some things have been moving faster by people working at home, yet other things seem to have stalled to no movement.  Reaching out to speak with someone in the FDA is a bit challenging, especially as they will not give any information on the status or review point of a submission like a 513(g) classification request.  The only suggestion is to send an email to the 513(g) group on the webpage and hopefully someone will respond - other than sending an email - it is just waiting for a government institution to complete a task (which could take a long time).  They do have metrics for 513(g) classification request because this is a User Fee activity, so you might be able to push them along.

Regarding the meeting minutes of your Q-Submission meeting - the meeting minutes are composed by you as the company.  When provided to FDA, just allows them to give comment, make any corrections, and/or agree with the content of the meeting minutes.  Be careful about not sending in the "official" version of the meeting minutes to ensure this is on record.  Just because the reviewer had not responded, you want to make sure the official meeting minutes are on record with the Q-Submission.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 15-Nov-2020 09:37
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

We submitted a 513(g) on Sep 4, but have not heard anything from FDA. We previously had a Pre-Sub meeting in May 2020, where FDA told us to submit a 513(g), suggesting it might be a de novo. We sent our version of the meeting minutes to FDA, but never got FDA's version. The reviewer just said they are severely understaffed.

 

We've seen a competitor come in as a wellness device. 

 

I previously wrote about it here:

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ba6e5311-b452-4730-9eaa-df3dc9aad585&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmba6e5311-b452-4730-9eaa-df3dc9aad585

 

What should we do?

Sorry to hear about your experience with the 513(g) process. It's one of the few pathways at FDA that doesn't have a MDUFA agreed timeline. In short, that means the review staff are not under any congressional pressure to respond within 60 days (even though it's one of the few files where they charge a user fee). 513(g) submissions are rare for many reasons, and we've had a few reviewers even tell us "well, I'm supposed to tell you to submit a 513(g) to get classification information but I'm not sure it's the best path forward." The most recent one we submitted, FDA responded on Day 125 after receipt. Ouch.

From that recent experience, here's what you can try: You can email your reviewer and see if they need any additional information (you did get some acknowledgement of receipt, correct?) Alternatively, you can always try the Ombudsman. They can look into it and try to get the review team to respond. Unfortunately, response time depends on FDA resources (and those are stretched at the Agency thanks/no thanks to Covid). Good luck! 


------------------------------
Allison Komiyama
AcKnowledge RS
San Diego CA United States
www.acknowledge-rs.com
------------------------------

Original Message:
Sent: 15-Nov-2020 09:37
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

We submitted a 513(g) on Sep 4, but have not heard anything from FDA. We previously had a Pre-Sub meeting in May 2020, where FDA told us to submit a 513(g), suggesting it might be a de novo. We sent our version of the meeting minutes to FDA, but never got FDA's version. The reviewer just said they are severely understaffed.

 

We've seen a competitor come in as a wellness device. 

 

I previously wrote about it here:

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ba6e5311-b452-4730-9eaa-df3dc9aad585&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmba6e5311-b452-4730-9eaa-df3dc9aad585

 

What should we do?

So I am curious now, just about to do a Pre-Sub proposing a path (510(k)) and proposing data in that to get better feedback and a teleconference (assuming they are not swamped).  And yes I realized it could have a queue for a while.  I didn't want to do a straight 513(g), because there is no opportunity to discuss it with the Agency at all and the fee is involved as well.  And yes, i just attended a webinar on this by a local FDA law firm confirming my opinion that 513(g)s were effectively not the best use of calendar time and money,  and were not totally binding, really.

So now, either though neither 513(g) or PreSub is truly "binding " on the Agency (they are Teflon and nothing sticks until they see the marketing application, or until the fat lady sings -should i sing?).....it sounds from this string that even if a Pre-Sub discussion is had, FDA may still make the client turn around and  pay for a non-binding 513(g)?

Allison, did you get feedback on acceptability of the classification/ regulatory path from the Pre-Sub, even if the reviewer told you "well, I m supposed to tell you to submit a 513(g)...."?  Or did you get at the very least a good tingly spider sense of how they would consider things in the future submissions such that you didn't need to do a 513(g) for that?

Clearly we know that industry timelines are really not FDA's priority, as much as safety, and their own timelines/performance.   Just wondering if a frustrated client is going to develop....  i am handling a few pre-Subs right now, so am very curious.

Thanks for insight....... i just think 513(g)s are practically worthless. 🙄

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 17-Nov-2020 03:01
From: Allison Komiyama
Subject: 513(g) - No response from FDA after 60 days

Sorry to hear about your experience with the 513(g) process. It's one of the few pathways at FDA that doesn't have a MDUFA agreed timeline. In short, that means the review staff are not under any congressional pressure to respond within 60 days (even though it's one of the few files where they charge a user fee). 513(g) submissions are rare for many reasons, and we've had a few reviewers even tell us "well, I'm supposed to tell you to submit a 513(g) to get classification information but I'm not sure it's the best path forward." The most recent one we submitted, FDA responded on Day 125 after receipt. Ouch.

From that recent experience, here's what you can try: You can email your reviewer and see if they need any additional information (you did get some acknowledgement of receipt, correct?) Alternatively, you can always try the Ombudsman. They can look into it and try to get the review team to respond. Unfortunately, response time depends on FDA resources (and those are stretched at the Agency thanks/no thanks to Covid). Good luck!


------------------------------
Allison Komiyama
AcKnowledge RS
San Diego CA United States
www.acknowledge-rs.com

Original Message:
Sent: 15-Nov-2020 09:37
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

We submitted a 513(g) on Sep 4, but have not heard anything from FDA. We previously had a Pre-Sub meeting in May 2020, where FDA told us to submit a 513(g), suggesting it might be a de novo. We sent our version of the meeting minutes to FDA, but never got FDA's version. The reviewer just said they are severely understaffed.

 

We've seen a competitor come in as a wellness device. 

 

I previously wrote about it here:

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ba6e5311-b452-4730-9eaa-df3dc9aad585&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmba6e5311-b452-4730-9eaa-df3dc9aad585

 

What should we do?

Be prepared to wait at least 4 months, if not more. After you submit your pre-sub they will likely close it in their system and request that you submit a pre-sub supplement to re-open it, or at least that's what happened when I submitted a pre-sub last month.

------------------------------
Jeffrey Freedman
QA/RA Specialist III
Lowell MA
United States
------------------------------

Original Message:
Sent: 18-Nov-2020 07:43
From: Ginger Cantor
Subject: 513(g) - No response from FDA after 60 days

So I am curious now, just about to do a Pre-Sub proposing a path (510(k)) and proposing data in that to get better feedback and a teleconference (assuming they are not swamped).  And yes I realized it could have a queue for a while.  I didn't want to do a straight 513(g), because there is no opportunity to discuss it with the Agency at all and the fee is involved as well.  And yes, i just attended a webinar on this by a local FDA law firm confirming my opinion that 513(g)s were effectively not the best use of calendar time and money,  and were not totally binding, really.

So now, either though neither 513(g) or PreSub is truly "binding " on the Agency (they are Teflon and nothing sticks until they see the marketing application, or until the fat lady sings -should i sing?).....it sounds from this string that even if a Pre-Sub discussion is had, FDA may still make the client turn around and  pay for a non-binding 513(g)?

Allison, did you get feedback on acceptability of the classification/ regulatory path from the Pre-Sub, even if the reviewer told you "well, I m supposed to tell you to submit a 513(g)...."?  Or did you get at the very least a good tingly spider sense of how they would consider things in the future submissions such that you didn't need to do a 513(g) for that?

Clearly we know that industry timelines are really not FDA's priority, as much as safety, and their own timelines/performance.   Just wondering if a frustrated client is going to develop....  i am handling a few pre-Subs right now, so am very curious.

Thanks for insight....... i just think 513(g)s are practically worthless. 🙄

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 17-Nov-2020 03:01
From: Allison Komiyama
Subject: 513(g) - No response from FDA after 60 days

Sorry to hear about your experience with the 513(g) process. It's one of the few pathways at FDA that doesn't have a MDUFA agreed timeline. In short, that means the review staff are not under any congressional pressure to respond within 60 days (even though it's one of the few files where they charge a user fee). 513(g) submissions are rare for many reasons, and we've had a few reviewers even tell us "well, I'm supposed to tell you to submit a 513(g) to get classification information but I'm not sure it's the best path forward." The most recent one we submitted, FDA responded on Day 125 after receipt. Ouch.

From that recent experience, here's what you can try: You can email your reviewer and see if they need any additional information (you did get some acknowledgement of receipt, correct?) Alternatively, you can always try the Ombudsman. They can look into it and try to get the review team to respond. Unfortunately, response time depends on FDA resources (and those are stretched at the Agency thanks/no thanks to Covid). Good luck!


------------------------------
Allison Komiyama
AcKnowledge RS
San Diego CA United States
www.acknowledge-rs.com

Original Message:
Sent: 15-Nov-2020 09:37
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

We submitted a 513(g) on Sep 4, but have not heard anything from FDA. We previously had a Pre-Sub meeting in May 2020, where FDA told us to submit a 513(g), suggesting it might be a de novo. We sent our version of the meeting minutes to FDA, but never got FDA's version. The reviewer just said they are severely understaffed.

 

We've seen a competitor come in as a wellness device. 

 

I previously wrote about it here:

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ba6e5311-b452-4730-9eaa-df3dc9aad585&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmba6e5311-b452-4730-9eaa-df3dc9aad585

 

What should we do?

Hi Jeffrey

I did tell the client that was the case on the timeline, but was not sure on the mechanism.  But again, if nobody is hearing on 513(g) on time either, what is the point of paying the fee? 

Sigh.  Life as we know it.  I understand some offices are accepting pre-Subs, some not, some yes, with a queue.... etc.

Take care,

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 18-Nov-2020 13:53
From: Jeffrey Freedman
Subject: 513(g) - No response from FDA after 60 days

Be prepared to wait at least 4 months, if not more. After you submit your pre-sub they will likely close it in their system and request that you submit a pre-sub supplement to re-open it, or at least that's what happened when I submitted a pre-sub last month.

------------------------------
Jeffrey Freedman
QA/RA Specialist III
Lowell MA
United States

Original Message:
Sent: 18-Nov-2020 07:43
From: Ginger Cantor
Subject: 513(g) - No response from FDA after 60 days

So I am curious now, just about to do a Pre-Sub proposing a path (510(k)) and proposing data in that to get better feedback and a teleconference (assuming they are not swamped).  And yes I realized it could have a queue for a while.  I didn't want to do a straight 513(g), because there is no opportunity to discuss it with the Agency at all and the fee is involved as well.  And yes, i just attended a webinar on this by a local FDA law firm confirming my opinion that 513(g)s were effectively not the best use of calendar time and money,  and were not totally binding, really.

So now, either though neither 513(g) or PreSub is truly "binding " on the Agency (they are Teflon and nothing sticks until they see the marketing application, or until the fat lady sings -should i sing?).....it sounds from this string that even if a Pre-Sub discussion is had, FDA may still make the client turn around and  pay for a non-binding 513(g)?

Allison, did you get feedback on acceptability of the classification/ regulatory path from the Pre-Sub, even if the reviewer told you "well, I m supposed to tell you to submit a 513(g)...."?  Or did you get at the very least a good tingly spider sense of how they would consider things in the future submissions such that you didn't need to do a 513(g) for that?

Clearly we know that industry timelines are really not FDA's priority, as much as safety, and their own timelines/performance.   Just wondering if a frustrated client is going to develop....  i am handling a few pre-Subs right now, so am very curious.

Thanks for insight....... i just think 513(g)s are practically worthless. 🙄

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 17-Nov-2020 03:01
From: Allison Komiyama
Subject: 513(g) - No response from FDA after 60 days

Sorry to hear about your experience with the 513(g) process. It's one of the few pathways at FDA that doesn't have a MDUFA agreed timeline. In short, that means the review staff are not under any congressional pressure to respond within 60 days (even though it's one of the few files where they charge a user fee). 513(g) submissions are rare for many reasons, and we've had a few reviewers even tell us "well, I'm supposed to tell you to submit a 513(g) to get classification information but I'm not sure it's the best path forward." The most recent one we submitted, FDA responded on Day 125 after receipt. Ouch.

From that recent experience, here's what you can try: You can email your reviewer and see if they need any additional information (you did get some acknowledgement of receipt, correct?) Alternatively, you can always try the Ombudsman. They can look into it and try to get the review team to respond. Unfortunately, response time depends on FDA resources (and those are stretched at the Agency thanks/no thanks to Covid). Good luck!


------------------------------
Allison Komiyama
AcKnowledge RS
San Diego CA United States
www.acknowledge-rs.com

Original Message:
Sent: 15-Nov-2020 09:37
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

We submitted a 513(g) on Sep 4, but have not heard anything from FDA. We previously had a Pre-Sub meeting in May 2020, where FDA told us to submit a 513(g), suggesting it might be a de novo. We sent our version of the meeting minutes to FDA, but never got FDA's version. The reviewer just said they are severely understaffed.

 

We've seen a competitor come in as a wellness device. 

 

I previously wrote about it here:

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ba6e5311-b452-4730-9eaa-df3dc9aad585&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmba6e5311-b452-4730-9eaa-df3dc9aad585

 

What should we do?

@Ginger Cantor I have found that in-person meetings at FDA have been the best way to get a read on what FDA believes the regulatory pathway to be when it's not clear. Sadly, the recent teleconference calls-only (with FDA's cameras always off) aren't as telling...though I confess I like being home more this year with my new baby! Many times at in-person meetings I've had someone from management in the room say "this should be in product code ABC" (YAY!) and that is swiftly carried into the notes we submit. There are often ways to read between the lines in their written response, for example, "we are unable to identify a suitable predicate for your device and believe this may not be appropriate for a 510(k) premarket notification. However, we believe this device may fulfil the eligibility criteria for a de novo application based on the moderate risk it poses to patients." This is almost always followed up with a recommendation that a 513(g) will confirm this if we choose to submit one. Sadly, the boiler plate language for 513(g) letters can be rather vague and often damning for companies who have to show it to investors. I've seen 513(g) letters that roughly state "you are Class III, PMA device" when it's clear from previous FDA interactions that the device is appropriate for automatic reclassification. Alternatively, some 513(g) letters do state that a de novo is appropriate so I'm unsure how those letters are written. These files are rare for reviewers and many I've spoken to at the Agency will state they've maybe reviewed one or two in their careers. I've found that the only sure way to get at whether a device needs a de novo or not (if it's truly unclear), is to submit the 510(k) and have it reviewed. It's often the overall cheapest (if you're a small business) and fastest (~60 days depending on when it's NSE'd) way to get a very thorough review of your device classification. True, no one likes getting an NSE and, yes, it's more work to prepare the file compared to a pre-sub or a 513(g). But at least it's reliable and more binding than the other options. Also, it keeps you from getting stuck in the vicious cycle of "we recommend you submit (yet another) pre-sub supplement" followed by "you have not submitted enough information in this pre-sub for us to respond to this question."

------------------------------
Allison Komiyama
AcKnowledge RS
San Diego CA United States
www.acknowledge-rs.com
------------------------------

Original Message:
Sent: 18-Nov-2020 07:43
From: Ginger Cantor
Subject: 513(g) - No response from FDA after 60 days

So I am curious now, just about to do a Pre-Sub proposing a path (510(k)) and proposing data in that to get better feedback and a teleconference (assuming they are not swamped).  And yes I realized it could have a queue for a while.  I didn't want to do a straight 513(g), because there is no opportunity to discuss it with the Agency at all and the fee is involved as well.  And yes, i just attended a webinar on this by a local FDA law firm confirming my opinion that 513(g)s were effectively not the best use of calendar time and money,  and were not totally binding, really.

So now, either though neither 513(g) or PreSub is truly "binding " on the Agency (they are Teflon and nothing sticks until they see the marketing application, or until the fat lady sings -should i sing?).....it sounds from this string that even if a Pre-Sub discussion is had, FDA may still make the client turn around and  pay for a non-binding 513(g)?

Allison, did you get feedback on acceptability of the classification/ regulatory path from the Pre-Sub, even if the reviewer told you "well, I m supposed to tell you to submit a 513(g)...."?  Or did you get at the very least a good tingly spider sense of how they would consider things in the future submissions such that you didn't need to do a 513(g) for that?

Clearly we know that industry timelines are really not FDA's priority, as much as safety, and their own timelines/performance.   Just wondering if a frustrated client is going to develop....  i am handling a few pre-Subs right now, so am very curious.

Thanks for insight....... i just think 513(g)s are practically worthless. 🙄

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com

Original Message:
Sent: 17-Nov-2020 03:01
From: Allison Komiyama
Subject: 513(g) - No response from FDA after 60 days

Sorry to hear about your experience with the 513(g) process. It's one of the few pathways at FDA that doesn't have a MDUFA agreed timeline. In short, that means the review staff are not under any congressional pressure to respond within 60 days (even though it's one of the few files where they charge a user fee). 513(g) submissions are rare for many reasons, and we've had a few reviewers even tell us "well, I'm supposed to tell you to submit a 513(g) to get classification information but I'm not sure it's the best path forward." The most recent one we submitted, FDA responded on Day 125 after receipt. Ouch.

From that recent experience, here's what you can try: You can email your reviewer and see if they need any additional information (you did get some acknowledgement of receipt, correct?) Alternatively, you can always try the Ombudsman. They can look into it and try to get the review team to respond. Unfortunately, response time depends on FDA resources (and those are stretched at the Agency thanks/no thanks to Covid). Good luck!


------------------------------
Allison Komiyama
AcKnowledge RS
San Diego CA United States
www.acknowledge-rs.com

Original Message:
Sent: 15-Nov-2020 09:37
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

We submitted a 513(g) on Sep 4, but have not heard anything from FDA. We previously had a Pre-Sub meeting in May 2020, where FDA told us to submit a 513(g), suggesting it might be a de novo. We sent our version of the meeting minutes to FDA, but never got FDA's version. The reviewer just said they are severely understaffed.

 

We've seen a competitor come in as a wellness device. 

 

I previously wrote about it here:

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ba6e5311-b452-4730-9eaa-df3dc9aad585&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmba6e5311-b452-4730-9eaa-df3dc9aad585

 

What should we do?

Hi Anon,
We have heard that in the COVID environment persons are being pulled into EUA reviews from areas they normally support, thus it is understandable that the group is short staffed. However, if a competitor is determined as Health Software then that can impact the decision process by identifying that a predicate exists. 
With regard to the 513g timeframe, we have had both experiences: one within the time frame and one grossly outside of it.  One recourse if you are not getting a satisfactory response is to move up the chain of command (ccing your contact) until you get your response.

------------------------------
Sarah Parsons RAC
Director Regulatory Affairs, Diagnostics
Pittsford NY
United States
------------------------------

Original Message:
Sent: 15-Nov-2020 09:37
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

We submitted a 513(g) on Sep 4, but have not heard anything from FDA. We previously had a Pre-Sub meeting in May 2020, where FDA told us to submit a 513(g), suggesting it might be a de novo. We sent our version of the meeting minutes to FDA, but never got FDA's version. The reviewer just said they are severely understaffed.

 

We've seen a competitor come in as a wellness device. 

 

I previously wrote about it here:

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ba6e5311-b452-4730-9eaa-df3dc9aad585&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmba6e5311-b452-4730-9eaa-df3dc9aad585

 

What should we do?

This is a bit of a business strategy and risk discussion as much as an RA one, but here are a few thoughts.

- Ping FDA again about the 513(g) - including central staff and not just the reviewer. That might break it loose, though FDA is swamped by Covid related items and is falling more and more behind, particularly in some review groups.

- if you think it is a 510(k), force the issue and submit one - it might still get delayed but at least is "on the clock" and allows you to start with the least burdensome approach before going de novo (which you still could always do)

- if you think it is 510(k) exempt, write up a really good rationale establishing what rule/regulation you fall under, and then proceed. Be sure you assess how QSR applies as well, and meet all relevant requirements

- if you want to go down the wellness path, make sure, first that your indications truly are wellness claims, and not claims that go into the medical device space. Possibly, but not certainly, your competitor did this, so you can use theirs as reference but I would do your own assessment here
* if you do this, make sure your business knows there may be risks if FDA disagrees with your assessment, though these risks could be likely to be the same for your competition

Do some combination of the wellness device approach and the 510(k) for the more "advanced" claims you actually want.

g-


------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 15-Nov-2020 09:37
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

We submitted a 513(g) on Sep 4, but have not heard anything from FDA. We previously had a Pre-Sub meeting in May 2020, where FDA told us to submit a 513(g), suggesting it might be a de novo. We sent our version of the meeting minutes to FDA, but never got FDA's version. The reviewer just said they are severely understaffed.

 

We've seen a competitor come in as a wellness device. 

 

I previously wrote about it here:

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ba6e5311-b452-4730-9eaa-df3dc9aad585&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmba6e5311-b452-4730-9eaa-df3dc9aad585

 

What should we do?

This message was posted by a user wishing to remain anonymous

Thanks everyone for the response.

We did E-mail the Device Classification mailbox and received a response with a CC to 2 of the FDA reviewers, one of whom participated in the Q-Sub in May. Note, we submitted the meeting minutes months ago. I think what Vincent is saying is to ask FDA to confirm the meeting minutes are on record with the Q-Sub.

 

The proposed device is an actual physical device, not just software. During our Pre-Sub in May, FDA raised concerns about the 510(k) exempt product code because of words: the product code included the word "water" and ours has alternative technology such that no liquid is required. We also asked feedback on a predicate cleared by a 510(k) (secondary code is the same 510(k) exempt code) with an identical intended use, and with a claim of no water. However, if you look in detail at the manual, you can see they do require water. FDA seemed leaning towards a de novo and asked us to submit a 513(g).

 

In our 513(g), we went through each similar device, had a table of the 8 or so most similar devices comparing intended uses and technology, none of which was exactly the same technology. Then another 20 less similar devices that had a 510(k). And then a list of 60 or so devices as an appendix that were 510(k) exempt. We had included that wellness device as the 2^nd most similar device, but at the time didn't know its classification. From looking at the claims on  the wellness device website (which we included in the 513(g)), I would NOT say no way is it a wellness device. However, after ordering the wellness device from them, and not being able to find it on any FDA database, we asked the wellness device manufacturer. That is when (a week ago) they told us they were under wellness. The founders Linkedin profile suggests they have been talking to FDA. So we find this very surprising. As I said, we included the wellness's device website in our 513(g), but did not say it was wellness since we didn't know at the time.

 

So a wide span – from wellness all the way to de novo.

 

The wellness product should arrive at our engineering offices in a few days so we can reverse engineer it. If the technology does look similar, we may go back to the 513(g) reviewers and point it out to them.

 

Original Message:
Sent: 17-Nov-2020 08:53
From: Ginger Glaser
Subject: 513(g) - No response from FDA after 60 days

This is a bit of a business strategy and risk discussion as much as an RA one, but here are a few thoughts.

- Ping FDA again about the 513(g) - including central staff and not just the reviewer. That might break it loose, though FDA is swamped by Covid related items and is falling more and more behind, particularly in some review groups.

- if you think it is a 510(k), force the issue and submit one - it might still get delayed but at least is "on the clock" and allows you to start with the least burdensome approach before going de novo (which you still could always do)

- if you think it is 510(k) exempt, write up a really good rationale establishing what rule/regulation you fall under, and then proceed. Be sure you assess how QSR applies as well, and meet all relevant requirements

- if you want to go down the wellness path, make sure, first that your indications truly are wellness claims, and not claims that go into the medical device space. Possibly, but not certainly, your competitor did this, so you can use theirs as reference but I would do your own assessment here
* if you do this, make sure your business knows there may be risks if FDA disagrees with your assessment, though these risks could be likely to be the same for your competition

Do some combination of the wellness device approach and the 510(k) for the more "advanced" claims you actually want.

g-


------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 15-Nov-2020 09:37
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

We submitted a 513(g) on Sep 4, but have not heard anything from FDA. We previously had a Pre-Sub meeting in May 2020, where FDA told us to submit a 513(g), suggesting it might be a de novo. We sent our version of the meeting minutes to FDA, but never got FDA's version. The reviewer just said they are severely understaffed.

 

We've seen a competitor come in as a wellness device. 

 

I previously wrote about it here:

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ba6e5311-b452-4730-9eaa-df3dc9aad585&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmba6e5311-b452-4730-9eaa-df3dc9aad585

 

What should we do?

This message was posted by a user wishing to remain anonymous

meant to say that based on the wellness product's website, there was no way I'd say it was wellness.
Original Message:
Sent: 17-Nov-2020 14:47
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

Thanks everyone for the response.

We did E-mail the Device Classification mailbox and received a response with a CC to 2 of the FDA reviewers, one of whom participated in the Q-Sub in May. Note, we submitted the meeting minutes months ago. I think what Vincent is saying is to ask FDA to confirm the meeting minutes are on record with the Q-Sub.

 

The proposed device is an actual physical device, not just software. During our Pre-Sub in May, FDA raised concerns about the 510(k) exempt product code because of words: the product code included the word "water" and ours has alternative technology such that no liquid is required. We also asked feedback on a predicate cleared by a 510(k) (secondary code is the same 510(k) exempt code) with an identical intended use, and with a claim of no water. However, if you look in detail at the manual, you can see they do require water. FDA seemed leaning towards a de novo and asked us to submit a 513(g).

 

In our 513(g), we went through each similar device, had a table of the 8 or so most similar devices comparing intended uses and technology, none of which was exactly the same technology. Then another 20 less similar devices that had a 510(k). And then a list of 60 or so devices as an appendix that were 510(k) exempt. We had included that wellness device as the 2^nd most similar device, but at the time didn't know its classification. From looking at the claims on  the wellness device website (which we included in the 513(g)), I would NOT say no way is it a wellness device. However, after ordering the wellness device from them, and not being able to find it on any FDA database, we asked the wellness device manufacturer. That is when (a week ago) they told us they were under wellness. The founders Linkedin profile suggests they have been talking to FDA. So we find this very surprising. As I said, we included the wellness's device website in our 513(g), but did not say it was wellness since we didn't know at the time.

 

So a wide span – from wellness all the way to de novo.

 

The wellness product should arrive at our engineering offices in a few days so we can reverse engineer it. If the technology does look similar, we may go back to the 513(g) reviewers and point it out to them.

 

Original Message:
Sent: 17-Nov-2020 08:53
From: Ginger Glaser
Subject: 513(g) - No response from FDA after 60 days

This is a bit of a business strategy and risk discussion as much as an RA one, but here are a few thoughts.

- Ping FDA again about the 513(g) - including central staff and not just the reviewer. That might break it loose, though FDA is swamped by Covid related items and is falling more and more behind, particularly in some review groups.

- if you think it is a 510(k), force the issue and submit one - it might still get delayed but at least is "on the clock" and allows you to start with the least burdensome approach before going de novo (which you still could always do)

- if you think it is 510(k) exempt, write up a really good rationale establishing what rule/regulation you fall under, and then proceed. Be sure you assess how QSR applies as well, and meet all relevant requirements

- if you want to go down the wellness path, make sure, first that your indications truly are wellness claims, and not claims that go into the medical device space. Possibly, but not certainly, your competitor did this, so you can use theirs as reference but I would do your own assessment here
* if you do this, make sure your business knows there may be risks if FDA disagrees with your assessment, though these risks could be likely to be the same for your competition

Do some combination of the wellness device approach and the 510(k) for the more "advanced" claims you actually want.

g-


------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 15-Nov-2020 09:37
From: Anonymous Member
Subject: 513(g) - No response from FDA after 60 days

This message was posted by a user wishing to remain anonymous

We submitted a 513(g) on Sep 4, but have not heard anything from FDA. We previously had a Pre-Sub meeting in May 2020, where FDA told us to submit a 513(g), suggesting it might be a de novo. We sent our version of the meeting minutes to FDA, but never got FDA's version. The reviewer just said they are severely understaffed.

 

We've seen a competitor come in as a wellness device. 

 

I previously wrote about it here:

https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=ba6e5311-b452-4730-9eaa-df3dc9aad585&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer#bmba6e5311-b452-4730-9eaa-df3dc9aad585

 

What should we do?