Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I am very much confused about the US impact of adding a new warning in the IFU. I have done my due-diligence of reviewing and making an assessment per Flowchart-A of the guidance doc 'Deciding when to submit a 510(k)' and it seems like if there are new risks , a potential special 510(k) is needed. There are associated new hazards in the risk files however those are what we are already aware of but now we are updating our risk files to add those additional hazards as a part of review. Does it mean that the addition of new warning is not technically leading to new risks and can be documented internally ?

Secondly, should those risks be specific to the new warnings ? 

I  just to want to understand when does a labeling change trigger a 510(k) submission. Any thoughts would be appreciated.

Thanks!

I'm failing to understand how there are new hazards being added to the risk files, yet were previously identified internally. Were they simply noted, but not addressed in the risk file initially submitted? If so it would seem that the initial risk analysis and controls were incomplete and these additions would be pertinent to determining if the individual and overall residual risk is outweighed by the benefit of the intended use of the device.

In my limited experience, it seems that A1.5 from flowchart A would indicate new risks require action.

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Christopher Erwin


Scottsdale AZ
United States
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Original Message:
Sent: 17-Mar-2021
From: Anonymous Member
Subject: Thoughts on 510(k)

This message was posted by a user wishing to remain anonymous

Hello,

I am very much confused about the US impact of adding a new warning in the IFU. I have done my due-diligence of reviewing and making an assessment per Flowchart-A of the guidance doc 'Deciding when to submit a 510(k)' and it seems like if there are new risks , a potential special 510(k) is needed. There are associated new hazards in the risk files however those are what we are already aware of but now we are updating our risk files to add those additional hazards as a part of review. Does it mean that the addition of new warning is not technically leading to new risks and can be documented internally ?

Secondly, should those risks be specific to the new warnings ? 

I  just to want to understand when does a labeling change trigger a 510(k) submission. Any thoughts would be appreciated.

Thanks!