Regulatory Open Forum

Hello Everyone, 

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo). 
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study. 

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

I'm experiencing a crisis of confidence in CDRH these days, so I don't know if it can be expected to know whether or not it should have problems with a study because it was done under the abbreviated IDE regulations.  I will be interested to hear what experience others might have had with this scenario recently.

The only problem this type of study SHOULD present to CDRH is that it may slow its review (510k or De novo) because it is seeing the study for the first time.  This issue should be easily addressed with a pre-510(k) or pre-De novo meeting.  (Unless of course, the would-be sponsor is a start-up that prefers to get its bad news later rather than sooner.)

I think this type of study presents a bigger problem for the manufacturer, since it increases the probability that the study was not designed or conducted in a manner that CDRH will accept. Since no submission is required for an abbreviated IDE, you can't address this problem with a pre-IDE meeting, but you may be able to address it by holding a pre-510(k) or pre-De novo meeting before the study is initiated.

The other problem that I have found to be common with device sponsors is that they are so excited to hear that a study can be conducted based solely on IRB approval, they race out the door to conduct the study.  They don't stop to read the regulations under which this is permitted, or the related guidance.  They then end up with a study that does not meet those requirements, which is to say, a study that was conducted in violation of the IDE regulations.
And that's always fun.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 10-May-2019 08:11
From: Kenny Walsh
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Hello Everyone,

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo).
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study.

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

Thanks for the feedback Julie. 

regards
Kenny

------------------------------
Kenny Walsh
Galway
Ireland
------------------------------

Original Message:
Sent: 10-May-2019 14:25
From: Julie Omohundro
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I'm experiencing a crisis of confidence in CDRH these days, so I don't know if it can be expected to know whether or not it should have problems with a study because it was done under the abbreviated IDE regulations.  I will be interested to hear what experience others might have had with this scenario recently.

The only problem this type of study SHOULD present to CDRH is that it may slow its review (510k or De novo) because it is seeing the study for the first time.  This issue should be easily addressed with a pre-510(k) or pre-De novo meeting.  (Unless of course, the would-be sponsor is a start-up that prefers to get its bad news later rather than sooner.)

I think this type of study presents a bigger problem for the manufacturer, since it increases the probability that the study was not designed or conducted in a manner that CDRH will accept. Since no submission is required for an abbreviated IDE, you can't address this problem with a pre-IDE meeting, but you may be able to address it by holding a pre-510(k) or pre-De novo meeting before the study is initiated.

The other problem that I have found to be common with device sponsors is that they are so excited to hear that a study can be conducted based solely on IRB approval, they race out the door to conduct the study.  They don't stop to read the regulations under which this is permitted, or the related guidance.  They then end up with a study that does not meet those requirements, which is to say, a study that was conducted in violation of the IDE regulations.
And that's always fun.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 10-May-2019 08:11
From: Kenny Walsh
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Hello Everyone,

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo).
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study.

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

I'm assuming that you did not get an IDE for the study.   I'd recommend a Pre-Submission meeting wirh the FDA.  It'd be a good idea to at least educate them about the study design and how it supports your market application.  Plus you can learn about their concerns about the study before getting a NSE letter.    Best of luck!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States
------------------------------

Original Message:
Sent: 10-May-2019 08:11
From: Kenny Walsh
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Hello Everyone,

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo).
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study.

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

I completely agree with Patrick's recommendation. I would like to add that my experience is that FDA has never had a problem with a study design that they did not approve or review before the study was conducted - IF - the study answers the questions they would have about effectiveness and safety. Sometimes those questions are not so clear to the industry.

Julie - regarding your comment about a start-up not wanting bad news earlier than later? Please expand.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 12-May-2019 16:53
From: Patrick Martin
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I'm assuming that you did not get an IDE for the study.   I'd recommend a Pre-Submission meeting wirh the FDA.  It'd be a good idea to at least educate them about the study design and how it supports your market application.  Plus you can learn about their concerns about the study before getting a NSE letter.    Best of luck!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States

Original Message:
Sent: 10-May-2019 08:11
From: Kenny Walsh
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Hello Everyone,

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo).
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study.

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

Thanks Patrick and Glen for your feedback.
We have not started the study yet - we are in the early stages of developing the regulatory strategy. I do believe that the study meets the criteria for an NSR but my concern with this is if we steam rolled ahead with this approach without any FDA involvement, we run a  risk that the study design will not support a future market application. 
I agree that the best strategy to follow is a pre-sub to educate FDA on the design for the future pre-market application. 

thanks for your thoughts. 
Kenny

------------------------------
Kenny Walsh
Galway
Ireland
------------------------------

Original Message:
Sent: 13-May-2019 09:03
From: Glen Park
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I completely agree with Patrick's recommendation. I would like to add that my experience is that FDA has never had a problem with a study design that they did not approve or review before the study was conducted - IF - the study answers the questions they would have about effectiveness and safety. Sometimes those questions are not so clear to the industry.

Julie - regarding your comment about a start-up not wanting bad news earlier than later? Please expand.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 12-May-2019 16:53
From: Patrick Martin
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I'm assuming that you did not get an IDE for the study.   I'd recommend a Pre-Submission meeting wirh the FDA.  It'd be a good idea to at least educate them about the study design and how it supports your market application.  Plus you can learn about their concerns about the study before getting a NSE letter.    Best of luck!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States

Original Message:
Sent: 10-May-2019 08:11
From: Kenny Walsh
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Hello Everyone,

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo).
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study.

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

Glen, investors want bad news early ("fail fast"), so they can promptly cut their losses and move on.  Startups want bad news later, because once investors move on, so do the startup's salaries.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 13-May-2019 09:03
From: Glen Park
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I completely agree with Patrick's recommendation. I would like to add that my experience is that FDA has never had a problem with a study design that they did not approve or review before the study was conducted - IF - the study answers the questions they would have about effectiveness and safety. Sometimes those questions are not so clear to the industry.

Julie - regarding your comment about a start-up not wanting bad news earlier than later? Please expand.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 12-May-2019 16:53
From: Patrick Martin
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I'm assuming that you did not get an IDE for the study.   I'd recommend a Pre-Submission meeting wirh the FDA.  It'd be a good idea to at least educate them about the study design and how it supports your market application.  Plus you can learn about their concerns about the study before getting a NSE letter.    Best of luck!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States

Original Message:
Sent: 10-May-2019 08:11
From: Kenny Walsh
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Hello Everyone,

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo).
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study.

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

OK, that makes sense. I am working on a paper on what happens to start-up companies that try to delay the bad news by false and/or misleading statements to the investors. Call it a cautionary tale.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 13-May-2019 17:41
From: Julie Omohundro
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Glen, investors want bad news early ("fail fast"), so they can promptly cut their losses and move on.  Startups want bad news later, because once investors move on, so do the startup's salaries.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-May-2019 09:03
From: Glen Park
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I completely agree with Patrick's recommendation. I would like to add that my experience is that FDA has never had a problem with a study design that they did not approve or review before the study was conducted - IF - the study answers the questions they would have about effectiveness and safety. Sometimes those questions are not so clear to the industry.

Julie - regarding your comment about a start-up not wanting bad news earlier than later? Please expand.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 12-May-2019 16:53
From: Patrick Martin
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I'm assuming that you did not get an IDE for the study.   I'd recommend a Pre-Submission meeting wirh the FDA.  It'd be a good idea to at least educate them about the study design and how it supports your market application.  Plus you can learn about their concerns about the study before getting a NSE letter.    Best of luck!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States

Original Message:
Sent: 10-May-2019 08:11
From: Kenny Walsh
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Hello Everyone,

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo).
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study.

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

Good morning.
My experience with FDA and NSR studies to support pre-market submissions have been positive.  I find it depends on the review team as well.  Some want to know everything well in advance, others are more open provided that the study design (and results) are in line with the labeling/claims you wish to seek.

I agree (and disagree) with Julie on her comment "I think this type of study presents a bigger problem for the manufacturer, since it increases the probability that the study was not designed or conducted in a manner that CDRH will accept."

I agree that there is an increased probability that the review team can push back and challenge the study design and results if you go ahead and do not consult with them before the study is conducted.  However, if the design of the study will statistically answer the question and the results show safety and efficacy to back up your claims, the agency must accept the data.  They cannot give an NSE simply because they were not consulted from the beginning. 

The start-up medical device world does not have all the money or time to consult with the agency in a pre-Sub to only get non-binding feedback from the agency prior to a study beginning.  The desired labeling/claims that are being sought for the product need to be thought through and a clear path using the study design to prove those claims.  If there are questions or doubts and the path is not clear, then a pre-Sub is in order.

Thanks for reading.

------------------------------
Douglas Oberly
South Windsor CT
United States
------------------------------

Original Message:
Sent: 14-May-2019 08:19
From: Glen Park
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

OK, that makes sense. I am working on a paper on what happens to start-up companies that try to delay the bad news by false and/or misleading statements to the investors. Call it a cautionary tale.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 13-May-2019 17:41
From: Julie Omohundro
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Glen, investors want bad news early ("fail fast"), so they can promptly cut their losses and move on.  Startups want bad news later, because once investors move on, so do the startup's salaries.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-May-2019 09:03
From: Glen Park
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I completely agree with Patrick's recommendation. I would like to add that my experience is that FDA has never had a problem with a study design that they did not approve or review before the study was conducted - IF - the study answers the questions they would have about effectiveness and safety. Sometimes those questions are not so clear to the industry.

Julie - regarding your comment about a start-up not wanting bad news earlier than later? Please expand.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 12-May-2019 16:53
From: Patrick Martin
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I'm assuming that you did not get an IDE for the study.   I'd recommend a Pre-Submission meeting wirh the FDA.  It'd be a good idea to at least educate them about the study design and how it supports your market application.  Plus you can learn about their concerns about the study before getting a NSE letter.    Best of luck!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States

Original Message:
Sent: 10-May-2019 08:11
From: Kenny Walsh
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Hello Everyone,

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo).
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study.

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

I totally agree with "if the design of the study will statistically answer the question and the results show safety and efficacy to back up your claims, the agency must accept the data."

I personally think the probability that a medical device company can/will design a study that statistically answers the question (or that even understands the concept of a research question, when, for example, four Harvard academics and a bunch of reviewers at the BMJ obviously do not) is pretty low, so for me this is a routine caution. 

I also cannot gauge the probability that a CDRH review team can recognize a study that is designed to statistically answer the question, but even before my current crisis of confidence, I would not have pegged that at 100%.  However, to me that's not really the point when it comes to getting your product on the market.  CDRH simply has to think that your study is designed to statistically answer the question.  And the only way to know what CDRH thinks is to ask CDRH.  I could be snarky and say that even it doesn't have enough confidence in its opinion to give you a binding answer, but that would be truly unfair. (Oh, oops, I said it anyway.)  I don't think any answer CDRH gives in advance of a full premarket review should be binding, even if it knows a well-designed study when it sees one.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 14-May-2019 09:13
From: Douglas Oberly
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Good morning.
My experience with FDA and NSR studies to support pre-market submissions have been positive.  I find it depends on the review team as well.  Some want to know everything well in advance, others are more open provided that the study design (and results) are in line with the labeling/claims you wish to seek.

I agree (and disagree) with Julie on her comment "I think this type of study presents a bigger problem for the manufacturer, since it increases the probability that the study was not designed or conducted in a manner that CDRH will accept."

I agree that there is an increased probability that the review team can push back and challenge the study design and results if you go ahead and do not consult with them before the study is conducted.  However, if the design of the study will statistically answer the question and the results show safety and efficacy to back up your claims, the agency must accept the data.  They cannot give an NSE simply because they were not consulted from the beginning.

The start-up medical device world does not have all the money or time to consult with the agency in a pre-Sub to only get non-binding feedback from the agency prior to a study beginning.  The desired labeling/claims that are being sought for the product need to be thought through and a clear path using the study design to prove those claims.  If there are questions or doubts and the path is not clear, then a pre-Sub is in order.

Thanks for reading.

------------------------------
Douglas Oberly
South Windsor CT
United States

Original Message:
Sent: 14-May-2019 08:19
From: Glen Park
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

OK, that makes sense. I am working on a paper on what happens to start-up companies that try to delay the bad news by false and/or misleading statements to the investors. Call it a cautionary tale.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 13-May-2019 17:41
From: Julie Omohundro
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Glen, investors want bad news early ("fail fast"), so they can promptly cut their losses and move on.  Startups want bad news later, because once investors move on, so do the startup's salaries.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-May-2019 09:03
From: Glen Park
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I completely agree with Patrick's recommendation. I would like to add that my experience is that FDA has never had a problem with a study design that they did not approve or review before the study was conducted - IF - the study answers the questions they would have about effectiveness and safety. Sometimes those questions are not so clear to the industry.

Julie - regarding your comment about a start-up not wanting bad news earlier than later? Please expand.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 12-May-2019 16:53
From: Patrick Martin
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I'm assuming that you did not get an IDE for the study.   I'd recommend a Pre-Submission meeting wirh the FDA.  It'd be a good idea to at least educate them about the study design and how it supports your market application.  Plus you can learn about their concerns about the study before getting a NSE letter.    Best of luck!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States

Original Message:
Sent: 10-May-2019 08:11
From: Kenny Walsh
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Hello Everyone,

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo).
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study.

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

Cool.  Where will you publish it?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 14-May-2019 08:19
From: Glen Park
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

OK, that makes sense. I am working on a paper on what happens to start-up companies that try to delay the bad news by false and/or misleading statements to the investors. Call it a cautionary tale.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 13-May-2019 17:41
From: Julie Omohundro
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Glen, investors want bad news early ("fail fast"), so they can promptly cut their losses and move on.  Startups want bad news later, because once investors move on, so do the startup's salaries.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 13-May-2019 09:03
From: Glen Park
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I completely agree with Patrick's recommendation. I would like to add that my experience is that FDA has never had a problem with a study design that they did not approve or review before the study was conducted - IF - the study answers the questions they would have about effectiveness and safety. Sometimes those questions are not so clear to the industry.

Julie - regarding your comment about a start-up not wanting bad news earlier than later? Please expand.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 12-May-2019 16:53
From: Patrick Martin
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

I'm assuming that you did not get an IDE for the study.   I'd recommend a Pre-Submission meeting wirh the FDA.  It'd be a good idea to at least educate them about the study design and how it supports your market application.  Plus you can learn about their concerns about the study before getting a NSE letter.    Best of luck!

------------------------------
Patrick Martin
VP, Clinical & Regulatory Affairs
Seattle WA
United States

Original Message:
Sent: 10-May-2019 08:11
From: Kenny Walsh
Subject: FDA Acceptance of NSR Clinical Study data to support a pre-market approval

Hello Everyone,

I would appreciate any feedback from the group on FDAs acceptance of clinical data from a non-significant risk (NSR) study to support a pre-market submission (510k or De Novo).
If the Study is conducted in accordance with the abbreviated requirements for an IDE and was approved by the IRB as an NSR, have you any experience of this causing an issues when the data are presented to FDA in a pre-market submission - i.e. that the FDA raises issues due to the fact that they were not involved in the approval of study.

thanks

------------------------------
Kenny Walsh
QA/RA Manager
Galway
Ireland
------------------------------

Original Message------

Cool.  Where will you publish it?

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------