Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

How many here did their first 510(k) or PMA or IDE submission on their own, without the supervision of a more experienced colleague or a consultant? I'm sure it's much easier with the help of someone familiar with the details of the process, but is that always necessary? If I just follow the instructions and do our first submission on my own, what are the chances it will go through?

Hello Anon,

It can be done on your own reading the guidance provided on the FDA website, the eSTAR portal is fairly self-explanatory, and the content fairly well defined.  Where experience is helpful in compiling a 510(k) submission is understanding content of device testing, clinical needs, and intended use of the device.  This can vary from device to device.  If the product has been around for a while, searching through the 510(k) Summary which are listed online is helpful to understand testing and/or any clinical needed.  My first 510(k)s were fairly straight-forward, though that was over 20 years ago where a whole submission was 50 pages or so.  Not so now.

I would say if the product is well-established the submission could probably be prepared internally.  If the product is newer technology, then you might want to get a mentor or some external expert advice.  It can be difficult because when FDA reviewers do get incomplete and sloppy submission it makes their function so much more difficult.  Whereas, if they have a nice, clear, complete submission it goes a long way for a successful review and also a quick review.  The other option you could do which I recommend, is put the submission all together, then just spend some time and money having someone knowledgeable to conduct an assessment which could tell you if anything major is missing or needed.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 21-Dec-2023 13:31
From: Anonymous Member
Subject: Submission learning curve

This message was posted by a user wishing to remain anonymous

How many here did their first 510(k) or PMA or IDE submission on their own, without the supervision of a more experienced colleague or a consultant? I'm sure it's much easier with the help of someone familiar with the details of the process, but is that always necessary? If I just follow the instructions and do our first submission on my own, what are the chances it will go through?

Dear Anon,

I suppose it also depends on how much experience your company has with the 510(k) submissions. If the engineers know a lot about what is required for the regulatory submission and have prepared sufficient documentation, I suppose you (or someone else) can proceed by yourself taking into account Mr. Richard's advice. 

But if you are part of a new company and the company doesn't have much experience, I am afraid it would be difficult to proceed without the advice of the outside consultant. 

I prepared the first 510(k) submission by copying the previous documentation with a little supervision. Referring the previous documentation made the process much easier. 

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Soichiro Iida
Kyoto
Japan
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Original Message:
Sent: 21-Dec-2023 13:31
From: Anonymous Member
Subject: Submission learning curve

This message was posted by a user wishing to remain anonymous

How many here did their first 510(k) or PMA or IDE submission on their own, without the supervision of a more experienced colleague or a consultant? I'm sure it's much easier with the help of someone familiar with the details of the process, but is that always necessary? If I just follow the instructions and do our first submission on my own, what are the chances it will go through?

Dear Anon,

Putting a 510(k) together and writing the various sections are just one one part of the equation. The eStar submission template is quite helpful in that it provides a good outline of what is required and links to further information (regulations and guidances). Having a regulatory peer with whom you can discuss any questions that pop up while you are working on the submission is helpful. 

The second part  is the quality of the data that you will submit. The best written submission will not be cleared if the data is not adequate/leaves open questions.

Wishing you all the best. Good luck!

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Pat
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Original Message:
Sent: 21-Dec-2023 13:31
From: Anonymous Member
Subject: Submission learning curve

This message was posted by a user wishing to remain anonymous

How many here did their first 510(k) or PMA or IDE submission on their own, without the supervision of a more experienced colleague or a consultant? I'm sure it's much easier with the help of someone familiar with the details of the process, but is that always necessary? If I just follow the instructions and do our first submission on my own, what are the chances it will go through?

This message was posted by a user wishing to remain anonymous

Thank you!!

Original Message:
Sent: 26-Dec-2023 10:37
From: Patricia Taige
Subject: Submission learning curve

Dear Anon,

Putting a 510(k) together and writing the various sections are just one one part of the equation. The eStar submission template is quite helpful in that it provides a good outline of what is required and links to further information (regulations and guidances). Having a regulatory peer with whom you can discuss any questions that pop up while you are working on the submission is helpful. 

The second part  is the quality of the data that you will submit. The best written submission will not be cleared if the data is not adequate/leaves open questions.

Wishing you all the best. Good luck!

------------------------------
Pat

Original Message:
Sent: 21-Dec-2023 13:31
From: Anonymous Member
Subject: Submission learning curve

This message was posted by a user wishing to remain anonymous

How many here did their first 510(k) or PMA or IDE submission on their own, without the supervision of a more experienced colleague or a consultant? I'm sure it's much easier with the help of someone familiar with the details of the process, but is that always necessary? If I just follow the instructions and do our first submission on my own, what are the chances it will go through?