Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ? 

Is there a device description and proposed intended use? you can propose the pathway to the FDA.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 22-May-2023 23:44
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Hello,

For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ? 

This message was posted by a user wishing to remain anonymous

Hi Ed,

I wanted to know if it is possible to request feedback on the risk classification, clinical protocol for IDE and the submission pathway in one pre-sub?

Original Message:
Sent: 23-May-2023 09:21
From: Ed Panek
Subject: FDA Pre-submission for a new device

Is there a device description and proposed intended use? you can propose the pathway to the FDA.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 22-May-2023 23:44
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Hello,

For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ? 

This message was posted by a user wishing to remain anonymous

For risk classification feedback, submit a 513(g) which has a user fee of $2,980 for a small business and $5,961 for a standard fee. Even though I have seen FDA provide feedback to a Pre-Sub regarding classification. The clinical protocol can be submitted as an attachment to the Pre-Sub. Within the Pre-Sub should have specific questions regarding the clinical protocol for FDA's feedback and concurrence. If the clinical protocol is effective, it can be revised based on FDA's pertinent feedback. For feedback on the regulatory pathway, provide a proposal in the Pre-Sub with specific questions for FDA's feedback.

Original Message:
Sent: 23-May-2023 19:28
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Hi Ed,

I wanted to know if it is possible to request feedback on the risk classification, clinical protocol for IDE and the submission pathway in one pre-sub?

Original Message:
Sent: 23-May-2023 09:21
From: Ed Panek
Subject: FDA Pre-submission for a new device

Is there a device description and proposed intended use? you can propose the pathway to the FDA.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 22-May-2023 23:44
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Hello,

For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ? 

This message was posted by a user wishing to remain anonymous

The first Pre-Sub should address the verification and validation study proposals (analytical and clinical) for FDA's feedback and concurrence as well as the proposed regulatory pathway (if planning for a future 510(k), a proposed predicate). It is recommended by FDA in their Q-Sub Program guidance document to target three to four substantial topics to allow sufficient FDA review time.

A link to the Q-Sub Program guidance document:
https://www.fda.gov/media/114034/download

Original Message:
Sent: 22-May-2023 23:44
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Hello,

For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ? 

Providing more information about the device would be beneficial in providing an accurate response. If the classification and submission pathway are not clear, you really need to start there because without that information you cannot adequately setup the clinical protocol for IDE. I suspect you have an idea of the classification and submission pathway but maybe are torn between a few different options. It is in your best interest to make an argument for the one which fits best and is the least burdensome and see what the FDA has to say about it in your initial pre-submission. 

Feel free to reach out directly for additional assistance. 

------------------------------
Wade Munsch
Regulatory Affairs Manager
Biotex, Inc.
Houston TX
United States
Company Website: www.biotexmedical.com
Test Lab Website: https://www.biotexmedical.com/criterion/
------------------------------

Original Message:
Sent: 22-May-2023 23:44
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Hello,

For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ? 

I wanted to echo what others have said. The purpose of a pre-submission is to get feedback from FDA on your planned submission. I'd highly suggest putting together the best proposed regulatory strategy you can and asking FDA in the pre-sub if they concur. If you ask FDA what they believe the classification etc. should be they will likely respond that you should submit a 513(g) request which does have a fee associated with it. FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act | FDA

In the first pre-submission, I think it is reasonable to expect that you could get clarity on what submission type FDA will require for your device and what type of validation data is likely to be required. If it is evident that a clinical trial would be required I would plan to have a pre-sub supplement to discuss the protocol with FDA. 

------------------------------
Michelle Hasse
Elkhart IN
United States
------------------------------

Original Message:
Sent: 22-May-2023 23:44
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Hello,

For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ? 

First step would be to come up with the intended use, description and submit a  513(g) Request  with FDA, this is specifically for classification request. it is advisable to utilize that and then work on the risk management, IDE, clinical pathway. Presubs recommendation by FDA is 3-4 substantial topics per meeting. If the topics are more than recommended FDA will come back to you to focus on more important ones. 

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
------------------------------

Original Message:
Sent: 22-May-2023 23:44
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Hello,

For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ? 

This message was posted by a user wishing to remain anonymous

Does Classification influence the IDE ?

Original Message:
Sent: 24-May-2023 10:15
From: Rajeswari Devanathan
Subject: FDA Pre-submission for a new device

First step would be to come up with the intended use, description and submit a  513(g) Request  with FDA, this is specifically for classification request. it is advisable to utilize that and then work on the risk management, IDE, clinical pathway. Presubs recommendation by FDA is 3-4 substantial topics per meeting. If the topics are more than recommended FDA will come back to you to focus on more important ones. 

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada

Original Message:
Sent: 22-May-2023 23:44
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Hello,

For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ? 

It definitely would. A lower class device will have less of a burden to show it can be used in humans than a higher class device. Additionally, if you have a predicate that will set the minimum bar for your study design because you have to show substantial equivalence. If your device is De Novo, then you would have much more flexibility in the study design but it still depends on other available interventions. You really need to be sure you do not have a predicate, then lock down the classification before attempting to submit and IDE.

------------------------------
Wade Munsch
Regulatory Affairs Manager
Biotex, Inc.
Houston TX
United States
Company Website: www.biotexmedical.com
Test Lab Website: https://www.biotexmedical.com/criterion/
------------------------------

Original Message:
Sent: 25-May-2023 23:42
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Does Classification influence the IDE ?

Original Message:
Sent: 24-May-2023 10:15
From: Rajeswari Devanathan
Subject: FDA Pre-submission for a new device

First step would be to come up with the intended use, description and submit a  513(g) Request  with FDA, this is specifically for classification request. it is advisable to utilize that and then work on the risk management, IDE, clinical pathway. Presubs recommendation by FDA is 3-4 substantial topics per meeting. If the topics are more than recommended FDA will come back to you to focus on more important ones. 

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada

Original Message:
Sent: 22-May-2023 23:44
From: Anonymous Member
Subject: FDA Pre-submission for a new device

This message was posted by a user wishing to remain anonymous

Hello,

For a new device in the final stages of development, where the classification is not clear nor the clinical pathway, what should the first pre-sub address ?  How many topics can the pre-sub cover ?