Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello friends,

Need urgent advice.

We just submitted a catch up 510k for one of our devices . The FDA did not come back with any other deficiency except for the labeling, where we need to provide a red-lined version for the updates. However over the years , the labeling has undergone several changes , and is a revamp of the cleared device labeling . Have you had any similar experience ? How would the FDA review such changes?

thanks

I've had lots of similar experience, as have others in the Forum.  Ultimately, the new 510(k) needs to elucidate all of relevant differences (those that can affect the substantial equivalence) between the subject device and the predicate device, and then make an assertion of substantial equivalence.  That remains true whether the predicate is your earlier device version or some other predicate.  When there has been a labeling change, FDA typically asks for redlined copies of the new labeling so the agency can more easily identify and review the various changes against the statutory "substantial equivalence" threshold that is the fundamental intent and premise of a section 510(k) notification.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 09-Oct-2021 03:07
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello friends,

Need urgent advice.

We just submitted a catch up 510k for one of our devices . The FDA did not come back with any other deficiency except for the labeling, where we need to provide a red-lined version for the updates. However over the years , the labeling has undergone several changes , and is a revamp of the cleared device labeling . Have you had any similar experience ? How would the FDA review such changes?

thanks

If you have made several changes over the years after you got your first 510(k), I guess you also have evaluated the changes and documented the decision each time based on which you decided not to submit a new 510(k) for the changes. If so, then you could pull out those decisions and send it to the reviewer along with your response to the deficiency.

------------------------------
Monoj Mon Kalita, PhD
Senior RA Specialist
New Taipei City
Taiwan
------------------------------

Original Message:
Sent: 09-Oct-2021 03:07
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello friends,

Need urgent advice.

We just submitted a catch up 510k for one of our devices . The FDA did not come back with any other deficiency except for the labeling, where we need to provide a red-lined version for the updates. However over the years , the labeling has undergone several changes , and is a revamp of the cleared device labeling . Have you had any similar experience ? How would the FDA review such changes?

thanks

Well, since you said this is a "catch up" 510(k), you should "catch up" on the labeling as well. Honestly that should have been done with the 510(k) and not wait for questions. That said, now is the time - make sure your updated labeling actually addresses the questions FDA had, and send them that. Regulations require disclosing all prior changes when a new 510(k) is filed, and as an added bonus you will have a new "baseline" for everything, including labeling, when you get done.

Ginger

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 09-Oct-2021 03:07
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello friends,

Need urgent advice.

We just submitted a catch up 510k for one of our devices . The FDA did not come back with any other deficiency except for the labeling, where we need to provide a red-lined version for the updates. However over the years , the labeling has undergone several changes , and is a revamp of the cleared device labeling . Have you had any similar experience ? How would the FDA review such changes?

thanks

This message was posted by a user wishing to remain anonymous

Hello Kevin,

Thanks for your response. As I mentioned the new labeling doesn't look anything like the old one , so providing a red-lined version would be a futile exercise as all the sections would have the red-line. We also provided a table of the key changes that the FDA wanted to look or was concerned about - indications , contraindications, warnings, precautions, complications and the rationale for the same , but they insisted on seeing the red-lined version. My question is how would they perceive this comparison?. Is there a different way of presenting the response ?
Original Message:
Sent: 09-Oct-2021 03:07
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello friends,

Need urgent advice.

We just submitted a catch up 510k for one of our devices . The FDA did not come back with any other deficiency except for the labeling, where we need to provide a red-lined version for the updates. However over the years , the labeling has undergone several changes , and is a revamp of the cleared device labeling . Have you had any similar experience ? How would the FDA review such changes?

thanks

If it's a complete strike out and replacement, so be it!

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States
------------------------------

Original Message:
Sent: 11-Oct-2021 18:04
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello Kevin,

Thanks for your response. As I mentioned the new labeling doesn't look anything like the old one , so providing a red-lined version would be a futile exercise as all the sections would have the red-line. We also provided a table of the key changes that the FDA wanted to look or was concerned about - indications , contraindications, warnings, precautions, complications and the rationale for the same , but they insisted on seeing the red-lined version. My question is how would they perceive this comparison?. Is there a different way of presenting the response ?
Original Message:
Sent: 09-Oct-2021 03:07
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello friends,

Need urgent advice.

We just submitted a catch up 510k for one of our devices . The FDA did not come back with any other deficiency except for the labeling, where we need to provide a red-lined version for the updates. However over the years , the labeling has undergone several changes , and is a revamp of the cleared device labeling . Have you had any similar experience ? How would the FDA review such changes?

thanks

My experience has been that FDA, simply for practical intents and purposes, will often request a redlined version of the revised labeling.  But since a redlined version isn't specifically a statutory/regulatory requirement, it means that FDA shouldn't be strictly requiring a redline as a condition of clearance other than insofar as what's needed for FDA to make its substantial equivalence comparison.  Accordingly, if there are so many redlines that it would defeat the purpose of making it easier for FDA to see the changes, then simply inform FDA of that, and then suggest an alternative way to communicate the changes to FDA.  For example, by itemizing the changes in a "before-and-after" or "old-and-new" table with cross-references to the page, section, caption, narrative, figure, etc., in the new labeling where the changes can be reviewed.  And ultimately, if FDA still demands a redlined version, then by all means, accommodate that request, as it's a simple clerical task for you.  I wouldn't focus too much on trying to manage or affect FDA's clerical needs.  Instead, keep your eye on the main goal, and that is making it clear for FDA exactly what has changed in the labeling.  A comparison matrix is a great way to go in that regard.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 11-Oct-2021 18:04
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello Kevin,

Thanks for your response. As I mentioned the new labeling doesn't look anything like the old one , so providing a red-lined version would be a futile exercise as all the sections would have the red-line. We also provided a table of the key changes that the FDA wanted to look or was concerned about - indications , contraindications, warnings, precautions, complications and the rationale for the same , but they insisted on seeing the red-lined version. My question is how would they perceive this comparison?. Is there a different way of presenting the response ?
Original Message:
Sent: 09-Oct-2021 03:07
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello friends,

Need urgent advice.

We just submitted a catch up 510k for one of our devices . The FDA did not come back with any other deficiency except for the labeling, where we need to provide a red-lined version for the updates. However over the years , the labeling has undergone several changes , and is a revamp of the cleared device labeling . Have you had any similar experience ? How would the FDA review such changes?

thanks

This message was posted by a user wishing to remain anonymous

Thanks all for your valuable comments  !
Original Message:
Sent: 12-Oct-2021 13:07
From: Kevin Randall, RAC
Subject: Catch up 510k and labeling changes

My experience has been that FDA, simply for practical intents and purposes, will often request a redlined version of the revised labeling.  But since a redlined version isn't specifically a statutory/regulatory requirement, it means that FDA shouldn't be strictly requiring a redline as a condition of clearance other than insofar as what's needed for FDA to make its substantial equivalence comparison.  Accordingly, if there are so many redlines that it would defeat the purpose of making it easier for FDA to see the changes, then simply inform FDA of that, and then suggest an alternative way to communicate the changes to FDA.  For example, by itemizing the changes in a "before-and-after" or "old-and-new" table with cross-references to the page, section, caption, narrative, figure, etc., in the new labeling where the changes can be reviewed.  And ultimately, if FDA still demands a redlined version, then by all means, accommodate that request, as it's a simple clerical task for you.  I wouldn't focus too much on trying to manage or affect FDA's clerical needs.  Instead, keep your eye on the main goal, and that is making it clear for FDA exactly what has changed in the labeling.  A comparison matrix is a great way to go in that regard.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 11-Oct-2021 18:04
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello Kevin,

Thanks for your response. As I mentioned the new labeling doesn't look anything like the old one , so providing a red-lined version would be a futile exercise as all the sections would have the red-line. We also provided a table of the key changes that the FDA wanted to look or was concerned about - indications , contraindications, warnings, precautions, complications and the rationale for the same , but they insisted on seeing the red-lined version. My question is how would they perceive this comparison?. Is there a different way of presenting the response ?
Original Message:
Sent: 09-Oct-2021 03:07
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello friends,

Need urgent advice.

We just submitted a catch up 510k for one of our devices . The FDA did not come back with any other deficiency except for the labeling, where we need to provide a red-lined version for the updates. However over the years , the labeling has undergone several changes , and is a revamp of the cleared device labeling . Have you had any similar experience ? How would the FDA review such changes?

thanks

This happened to me as well. The FDA understood that I was on their side, trying to make up for years of oversight. They cut me some slack. I hope they do that for you also.
I would run a comparison with the label from the last submission, with the current label. On that particular red line, ignore anything that happened in the middle time period.
However you will still need to address the labels that were on distributed product during that middle period. This might be a second red line, am appendix of sorts to the first. Some information might have been removed and added on and taken off again. You should provide information about that transition.
The main things are (1) to show that the product was never misbranded during those iterations, and (2) to show what it's like now and how it's different from the last time FDA saw it. 
I hope this helps.
Of course, please don't consider this specific legal advice since that would require an evaluation of all the iterations.

------------------------------
Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States
------------------------------

Original Message:
Sent: 09-Oct-2021 03:07
From: Anonymous Member
Subject: Catch up 510k and labeling changes

This message was posted by a user wishing to remain anonymous

Hello friends,

Need urgent advice.

We just submitted a catch up 510k for one of our devices . The FDA did not come back with any other deficiency except for the labeling, where we need to provide a red-lined version for the updates. However over the years , the labeling has undergone several changes , and is a revamp of the cleared device labeling . Have you had any similar experience ? How would the FDA review such changes?

thanks