Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

I would like to gain some wisdom on the labeling related changes for a 510(k) released product. The manufacturer is planning to revise the labeling for the new warnings and storage/transportation introduction in the IFU. I was using 'Deciding when to submit 510(k) issued in Oct 2017' as my guidance document for the regulatory strategy related to this change.

The guidance document is not referring to the storage conditions information. I would like to understand from your experience what changes can be qualified for a special 510(k) submission related to the labeling change.

Any guidance would be appreciated.

Hello Anon,

As long as the change in storage conditions does not significantly affect safety or efficacy of the device, then it can usually be documented internally.  In my experience, addition of or changing storage conditions can usually be documented internally.  The guidance document is not that specific you will find, so it is up to your own decision making process on determining whether change impacts safety or efficacy.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 08-Mar-2021 14:47
From: Anonymous Member
Subject: 510(k) question

This message was posted by a user wishing to remain anonymous

Hi all,

I would like to gain some wisdom on the labeling related changes for a 510(k) released product. The manufacturer is planning to revise the labeling for the new warnings and storage/transportation introduction in the IFU. I was using 'Deciding when to submit 510(k) issued in Oct 2017' as my guidance document for the regulatory strategy related to this change.

The guidance document is not referring to the storage conditions information. I would like to understand from your experience what changes can be qualified for a special 510(k) submission related to the labeling change.

Any guidance would be appreciated.

Hi,

Based on the October 2017 guidance, a risk-base assessment of the labeling changes should be completed.  Are "new risks or significantly modified existing risks" identified based on the manufacturer adding warnings and storage conditions?  If Yes, based on the guidance a new 510(k) is required. 

I have not gone through the new Special 510(k) guidance in detail, issued in 2019; however, if the changes are to the manufacturer's own device, which the labeling changes you describe are, you should evaluate the other Special 510(k) criteria to determine whether you meet it and can supply the needed submission data.  See the attached Special 510(k) guidance to determine if you meet the criteria.  I assume based on what you said that a Special 510(k) would be an appropriate path.  

Kind regards,

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Alyssa Thomas RAC
Principal Consultant
Beaverton OR
United States
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Original Message:
Sent: 08-Mar-2021 14:47
From: Anonymous Member
Subject: 510(k) question

This message was posted by a user wishing to remain anonymous

Hi all,

I would like to gain some wisdom on the labeling related changes for a 510(k) released product. The manufacturer is planning to revise the labeling for the new warnings and storage/transportation introduction in the IFU. I was using 'Deciding when to submit 510(k) issued in Oct 2017' as my guidance document for the regulatory strategy related to this change.

The guidance document is not referring to the storage conditions information. I would like to understand from your experience what changes can be qualified for a special 510(k) submission related to the labeling change.

Any guidance would be appreciated.