Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello RAPs colleagues,
I am working in a small company and my manager has not worked on an original PMA. We wanted to know since we are a brand new device for which there is no predicate, what should we include in our first module for the device classification. We know the medical specialty under which our device would classify but we don't have a CFR or a 3 letter code.

1. Do we have to get that information (a CFR or a 3 letter code) before we submit our first module? If yes, how should we engage with FDA regarding that?
2. If we do not have that information, should we leave it blank in our PMA module #1?

Appreciate your input.​

Hello Anon,

As a Class III device using the PMA process with no predicate in the first module for the Product Code and Regulation, I have just put 'None Listed,' as this is the reason having to go down the PMA route because there is no predicate.  The PMA and De Novo process when FDA issues the Decision Summary will include a newly assigned Product Code and Regulation Number (as applicable).  This is something they do, so in Module 1 of a Modular PMA, I had just put None Listed or None Assigned something like that - I also would not necessarily leave it blank.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 26-Oct-2021 02:35
From: Anonymous Member
Subject: FDA Class III Classification (PMA)

This message was posted by a user wishing to remain anonymous

Hello RAPs colleagues,
I am working in a small company and my manager has not worked on an original PMA. We wanted to know since we are a brand new device for which there is no predicate, what should we include in our first module for the device classification. We know the medical specialty under which our device would classify but we don't have a CFR or a 3 letter code.

1. Do we have to get that information (a CFR or a 3 letter code) before we submit our first module? If yes, how should we engage with FDA regarding that?
2. If we do not have that information, should we leave it blank in our PMA module #1?

Appreciate your input.​

You can leave it blank. However, it is generally a really good idea to let FDA know a PMA is coming - via a pre-sub, or a call or something. PMA staff and/or DICE can be really helpful with questions like this too.

Ginger

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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 26-Oct-2021 02:35
From: Anonymous Member
Subject: FDA Class III Classification (PMA)

This message was posted by a user wishing to remain anonymous

Hello RAPs colleagues,
I am working in a small company and my manager has not worked on an original PMA. We wanted to know since we are a brand new device for which there is no predicate, what should we include in our first module for the device classification. We know the medical specialty under which our device would classify but we don't have a CFR or a 3 letter code.

1. Do we have to get that information (a CFR or a 3 letter code) before we submit our first module? If yes, how should we engage with FDA regarding that?
2. If we do not have that information, should we leave it blank in our PMA module #1?

Appreciate your input.​