Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues!

I would like to create a procedure for my company on how to redact a 510(k) when requested by the FDA.  That being said, I have a couple of questions:

1. Does FDA have information anywhere on their process when a FOIA request is received?
2. Who should be involved in 510(k) redaction?
3. Best practices for 510(k) redaction

Thank you!

That is a really good idea to have a methodology for redacting information especially defined in a procedure so it can be utilised for consistency in the future.  To answer your questions:

1. There are some processes the government uses, but most of the information is still done internally.  You can find some further information here (part of their website was not working for me at posting time) The Freedom of Information Act: U.S. Department of State - Freedom of Information Act 
2. This should be a multi-disciplinary team to review the contents of a 510(k) or PMA that is on file with FDA.  Though in reality or more in my experience as the responsible quality/regulatory person, I did the redacting.  Then I just had the CEO/President review and sent back to FDA.
3. I do not know of any source for redacting, but I can imagine there is some information out there from solicitor or lawyer sites.  I can say from experience that there is a fine line between redacting too much and too little.  One time we redacted too much and FDA sent it back to us telling us to 'try again'.  The Engineering Director was a little overzealous and was removing whole pages.  But also from experience, the FDA does not back very much at specific technical or proprietary information.

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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 02-May-2018 16:11
From: Anonymous Member
Subject: 510(k) Redaction

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues!

I would like to create a procedure for my company on how to redact a 510(k) when requested by the FDA.  That being said, I have a couple of questions:

1. Does FDA have information anywhere on their process when a FOIA request is received?
2. Who should be involved in 510(k) redaction?
3. Best practices for 510(k) redaction

Thank you!

This message was posted by a user wishing to remain anonymous

I echo Richard's comments that it would be good practice to have an internal job aid about how to redact a 510k submission requested from FDA FOI.

I myself believe it is important to have the engineering manager and RA manager review the proposed 510k redacted by FDA. We just did one and found several entire sections of proprietary information that were missed. We are now asking FDA to withheld.

One technical aspect of this process is that we needed to have Adobe Pro to be able to perform the redbox redaction (my Adobe Acrobat XI was not powerful enough). Otherwise we would have had to go through paper printing and manual redbox... not optimum!

Also note that as per the FOI process we were asked to respond within 10 business days but we negotiate a more logical timing (especially since the document was over 3000 pages long).


Original Message:
Sent: 04-May-2018 05:06
From: Richard Vincins
Subject: 510(k) Redaction

That is a really good idea to have a methodology for redacting information especially defined in a procedure so it can be utilised for consistency in the future.  To answer your questions:

1. There are some processes the government uses, but most of the information is still done internally.  You can find some further information here (part of their website was not working for me at posting time) The Freedom of Information Act: U.S. Department of State - Freedom of Information Act
2. This should be a multi-disciplinary team to review the contents of a 510(k) or PMA that is on file with FDA.  Though in reality or more in my experience as the responsible quality/regulatory person, I did the redacting.  Then I just had the CEO/President review and sent back to FDA.
3. I do not know of any source for redacting, but I can imagine there is some information out there from solicitor or lawyer sites.  I can say from experience that there is a fine line between redacting too much and too little.  One time we redacted too much and FDA sent it back to us telling us to 'try again'.  The Engineering Director was a little overzealous and was removing whole pages.  But also from experience, the FDA does not back very much at specific technical or proprietary information.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 02-May-2018 16:11
From: Anonymous Member
Subject: 510(k) Redaction

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues!

I would like to create a procedure for my company on how to redact a 510(k) when requested by the FDA.  That being said, I have a couple of questions:

1. Does FDA have information anywhere on their process when a FOIA request is received?
2. Who should be involved in 510(k) redaction?
3. Best practices for 510(k) redaction

Thank you!

We have a procedure for redaction, but I have a question.

I have had these requests from FDA, and I've had them direct from competitors.

What are our obligations in responding directly to competitors?

Thank you.

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Corey Jaseph RAC
Director of Regulatory Affairs
South Jordan UT
United States
------------------------------

Original Message:
Sent: 02-May-2018 16:11
From: Anonymous Member
Subject: 510(k) Redaction

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues!

I would like to create a procedure for my company on how to redact a 510(k) when requested by the FDA.  That being said, I have a couple of questions:

1. Does FDA have information anywhere on their process when a FOIA request is received?
2. Who should be involved in 510(k) redaction?
3. Best practices for 510(k) redaction

Thank you!

Original Message------

We have a procedure for redaction, but I have a question.

I have had these requests from FDA, and I've had them direct from competitors.

What are our obligations in responding directly to competitors?

Thank you.

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
South Jordan UT
United States
------------------------------

That is correct, one of the main reasons that I advise my clients to complete a 510(k) Summary and not a 510(k) Statement.  Request for a 510(k) Statement must provide the entire "redacted" 510(k) submission within 30 days, and I have seen FDA get quite serious with companies that do not maintain this.  Whereas, if there is a 510(k) Summary any company must request a copy of the 510(k) application through the Freedom of Information Act.  If there is a 510(k) Summary there is no obligation to provide directly to a competitor, they must go through the FOI process.

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs
------------------------------

Original Message:
Sent: 05-May-2018 07:49
From: Ginger Cantor
Subject: 510(k) Redaction

Hello Corey

If you filed  510(k) statement, you are obligated to send anyone who makes a request a copy of your 510(k) within 30 calendar days at no cost. You can redact trade secret and confidential information (e.g. Specific composition, proprietary methods,) but cannot redact information related to safety and efficacy.

If you filed a 510(k) Summary, you are in no way obligated to provide anyone with a copy directly, except if FDA asks for a redacted copy (or in a court-order I suppose). Anyone else, tell them to go to FOI services to get it.

Best regards,

Ginger Cantor, MBA, RAC

Centaur Consulting LLC centaurconsultingllc@gmail.com

(715) 307-1850

Original Message------

We have a procedure for redaction, but I have a question.

I have had these requests from FDA, and I've had them direct from competitors.

What are our obligations in responding directly to competitors?

Thank you.

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
South Jordan UT
United States
------------------------------

While this may be obvious to the folks posting, I seems worth stating that the reason you have the right to redact is to protect information that is either confidential/proprietary or is protected by privacy rights.  These are exceptions to the FOIA rule, and, while we're used to seeing them in warning letters, the rules are the same in this setting, when the FDA is asking you for a redacted copy of your own submission to respond to a FOIA request they received.   The FDA is "in the middle" on this issue, as they are going to have to agree with your redactions and defend them if the requestor thinks they were too broad.

In warning letters, you may have seen the "(b)(4)" and "(b)(6)" deletions.

The "(b)(4)" exception is for proprietary info such as trade secrets (confidential info that has economic value in the hands of a competitor). 
The "(b)(6)" exception covers privacy issues, such as specific references to individuals.

As you implement your redaction process, you'll want to make a simple table that states what language was blacked out and why (e.g., patient/doctor personal info, proprietary algorithm description, process/testing methods that are custom-made but no patented, etc.).  While big companies will involve legal, this doesn't need to be an expensive legal review, as most companies are well aware of the competition and who has what intellectual property.   You only need a clear explanation, and technical people love tables with short explanations, as opposed to the long narratives that lawyers like me are trained to write  :)    

For those who want the full gory legal details of FOIA and FDA, including statutory citations, here's a nice but old letter that covers it:  
https://www.citizen.org/sites/default/files/2181.pdf


Roger

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Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361
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Original Message:
Sent: 02-May-2018 16:11
From: Anonymous Member
Subject: 510(k) Redaction

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues!

I would like to create a procedure for my company on how to redact a 510(k) when requested by the FDA.  That being said, I have a couple of questions:

1. Does FDA have information anywhere on their process when a FOIA request is received?
2. Who should be involved in 510(k) redaction?
3. Best practices for 510(k) redaction

Thank you!