Regulatory Open Forum

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

Yes and the customer will redact all confidential information.
-------------------------------------------
Kelli Tanzella
Leader, Global Regulatory Affairs, Clinical, and Compliance
Thermo Fisher Scientific Inc.
Grand Island NY
United States
-------------------------------------------



Original Message:
Sent: 4/23/2015 1:30:48 PM
From: ensinson@gmail.com
Subject: 510(k) FOIA Request

Hello,  I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information?  Please advise and thank you. ------------------------------------------- Edsel Sinson Fullerton CA United States -------------------------------------------

Continuing on the discussion ...
how much redacting of a 510(k) is allowed?

I recently submitted an FOI request, and the received document was almost completely redacted. The only thing that wasn't redacted was the summary and the FDA forms, though they too were partially redacted.
All of proposed labeling, entire product description, entire software, and bench testing were redacted; and by entire I mean full pages blacked out. The executive summary and equivalence discussion sections were for the most part redacted too.

When I voiced my concern with the FDA stuff that the redaction was too extensive, I was told that it was allowed under FOIA exemptions, specifically b4 and in some cases b6.



The FDA person coordinating my request also told me that he not only contacts the owners of the file that was requested under the FOIA, but frequently instructs what information should be redacted for example when the owner does not know what to redact or if they don't redact enough.
 
--
-------------------------------------------
Michael Zagorski RAC
Director of Regulatory Affairs and Quality
Impact Applications, Inc.
Pittsburgh PA
United States
-------------------------------------------


Original Message:
Sent: 04-24-2015 07:48
From: Kelli Tanzella
Subject: 510(k) FOIA Request


Yes and the customer will redact all confidential information.
-------------------------------------------
Kelli Tanzella
Leader, Global Regulatory Affairs, Clinical, and Compliance
Thermo Fisher Scientific Inc.
Grand Island NY
United States
-------------------------------------------

Michael,

Thank you for sharing your experience.

Since FOIA requests to the FDA get rarely challenged beyond orally challenging inquiry or even emails, I am not sure whether lack of real challenges has caused or rather contributed to current FDA practice on the FOIA.

Whether FDA does good job at really redacting the info that must/should have been redacted under exemption 4 and 6 have been sometimes questionable. 

Industry should get familiar with the FDA's FOIA staff manual guides including exemption 4 and 6 at 
http://fdaguidance.net/fda-foia-staff-manual-guides/

___________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 


Original Message:
Sent: 04-30-2015 08:24
From: Michael Zagorski
Subject: 510(k) FOIA Request

Continuing on the discussion ...
how much redacting of a 510(k) is allowed?

I recently submitted an FOI request, and the received document was almost completely redacted. The only thing that wasn't redacted was the summary and the FDA forms, though they too were partially redacted.
All of proposed labeling, entire product description, entire software, and bench testing were redacted; and by entire I mean full pages blacked out. The executive summary and equivalence discussion sections were for the most part redacted too.

When I voiced my concern with the FDA stuff that the redaction was too extensive, I was told that it was allowed under FOIA exemptions, specifically b4 and in some cases b6.



The FDA person coordinating my request also told me that he not only contacts the owners of the file that was requested under the FOIA, but frequently instructs what information should be redacted for example when the owner does not know what to redact or if they don't redact enough.
 
--
-------------------------------------------
Michael Zagorski RAC
Director of Regulatory Affairs and Quality
Impact Applications, Inc.
Pittsburgh PA
United States
-------------------------------------------


Original Message:
Sent: 04-24-2015 07:48
From: Kelli Tanzella
Subject: 510(k) FOIA Request


Yes and the customer will redact all confidential information.
-------------------------------------------
Kelli Tanzella
Leader, Global Regulatory Affairs, Clinical, and Compliance
Thermo Fisher Scientific Inc.
Grand Island NY
United States
-------------------------------------------

Hi Edsel,

Yes, FDA will contact the owner of the 510(k) and provide the owner with the opportunity to redact any confidential or proprietary information from the 510(k) before FDA provides the 510(k) to the FOI requestor.

Thanks,

-------------------------------------------
Barbara Fant PharmD
President & CEO
Cincinnati OH
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

Kelli,

If the FDA already has a redacted copy on file, will they still contact that company?  I know of one occasion where the company was not contacted when I submitted an FOIA request.

 John

-------------------------------------------
John Minier RAC
Small Bone Innovations, Inc
Highland Mills NY
United States
-------------------------------------------

Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

The FDA has a backlog of about 2500 FOIA requests. FDA called me on the phone a few months ago and told me that there was a company asking for our 510(k), which HE had redacted for us to save time, and just wanted us to confirm his redaction. He emailed it to us, and we emailed our response back. From our viewpoint he did a great job. We only wanted one more thing redacted, and we were done with the whole process the same day.

-------------------------------------------
Paula Bojsen
Global Regulatory Compliance Manager
Grand Rapids, MI
United States
-------------------------------------------


Original Message:
Sent: 04-24-2015 08:14
From: John Minier
Subject: 510(k) FOIA Request

Kelli,

If the FDA already has a redacted copy on file, will they still contact that company?  I know of one occasion where the company was not contacted when I submitted an FOIA request.

 John

-------------------------------------------
John Minier RAC
Small Bone Innovations, Inc
Highland Mills NY
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

Hi,
Usually not, although one can do an FOI request to see who has asked for copies of the 510k under FOIA.
If the company has not redacted the 510k, then they will be asked to do so and that is a signal that someone has requested it.
If this is a concern, there are ways around that. Just give me a shout ...   arankis@aarankis.com.
Art

-------------------------------------------
A Arthur Rankis
President
A. A. Rankis & Associates, Inc.
Acton MA
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

Yes, they will send the 510k to the owner and ask them to redact any confidential info before sending to you.

-------------------------------------------
Carroll Hoyle
Sr. Global Regulatory Affairs
BSN Medical
Rutherford College NC
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

I agree with the previous posts, but would add that the company will not know who is requesting the information. 
-------------------------------------------
Jen Allen
Director, New Product Regulatory Affairs
Sage Products LLC
Cary IL
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

I did have the experience that the requestor (previously unknown to me) was not satisfied with the level of redaction that we did.  They complained to FDA, who forwarded the letter to my company for comment.  This is how we learned who was requesting the information, but otherwise we would not have known.

-------------------------------------------
Sarah Parsons RAC
Associate Director Regulatory Affairs
Janssen Diagnostics
Rochester NY
United States
-------------------------------------------


Original Message:
Sent: 04-24-2015 09:23
From: Jen Allen
Subject: 510(k) FOIA Request


I agree with the previous posts, but would add that the company will not know who is requesting the information. 
-------------------------------------------
Jen Allen
Director, New Product Regulatory Affairs
Sage Products LLC
Cary IL
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

Hello Edsel,

Yes, FDA will notify the company, and give them the opportunity to redact their 510(k) before answering your request. They give the company five days to accomplish redaction. Please follow this link:

https://www.globalcomplianceseminar.com/510k-predisclosure-notification/


-------------------------------------------
Patrick Lynch
Fremont CA
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

Edsel,

"will the FDA notify that company that I am requesting such information?"

Yes and No because it is done on a case by case under the surrounding circumstances situated.  

Why is my answer "Yes or No"?

First you need to understand how the FOIA process works (especially 510(k) cases) including FDA notification to the submitter, the submitter's rights, Executive Order, etc. You may refer to http://wp.me/P2EoXX-1tL 

My 510(k) Practices

For my client (submitter) to have a chance to object to some contents later if requested by a third party (say, requested by a third party first time), I use some language, having/forcing (sort of) the FDA to contact the submitter as my client doesn't generally intend to waive any rights....

It shouldn't be believed that the FDA can/will do miraculously redact on their own initiatives without considering the submitter's requests/comments.  Of course, FDA can/is capable of, but they have no rights to waive your legal rights to retain your protected information without your express consent or you may also object to some contents in an attempt to withhold some info., when/if it is necessary...

It is important to know your rights and the process at https://www.globalcomplianceseminar.com/510k-predisclosure-notification/

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

I agree with Jen Allen and I learned something new with Sarah Parson's response!  You can always request the FOIA through a consultant if you're concerned.  I've had clients do the same for requesting a 510(k) when the predicate device's sponsor has a 510(k) Statement instead of a Summary.  That way it comes via my letterhead instead of theirs.


-------------------------------------------
Allison Komiyama PHD, RAC
Principal
Acknowledge Regulatory Strategies
San Diego CA
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

You also might try FOI Services (www.foiservices.com).  They have a number of 510(k)'s in their databases already.  Of course, there is a charge, but it is a lot faster than FDA.

______________________________________________
Michael A. Swit, Esq.




Original Message:
Sent: 04-24-2015 12:26
From: Allison Komiyama
Subject: 510(k) FOIA Request

I agree with Jen Allen and I learned something new with Sarah Parson's response!  You can always request the FOIA through a consultant if you're concerned.  I've had clients do the same for requesting a 510(k) when the predicate device's sponsor has a 510(k) Statement instead of a Summary.  That way it comes via my letterhead instead of theirs.


-------------------------------------------
Allison Komiyama PHD, RAC
Principal
Acknowledge Regulatory Strategies
San Diego CA
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

If anyone wants to ask for legal basis for 510(k) disclosures under FOIA, here is the info at http://wp.me/P4xpOK-10s

When one works as a consultant for a firm and requests a redacted copy of the 510(k)s under FOIA on behalf of your client, it can be easily traceable. Sometimes and often, a consultant or consulting firm can be/is listed as preparer although I sometimes function as a ghost adviser/preparer/writer.  

What if when the issues become serious later as part of patent infringement disputes, will the consultant or consulting firm likely to be blamed for/liable for willful infringement (treble damages)?  I am just throwing a question.

It is always good to exercise FOIA practices with good intent (e.g., without intending reverse engineering). 

Sometimes, we can even do better without looking at others' 510(k)s.  

D



Original Message:
Sent: 04-24-2015 12:26
From: Allison Komiyama
Subject: 510(k) FOIA Request

I agree with Jen Allen and I learned something new with Sarah Parson's response!  You can always request the FOIA through a consultant if you're concerned.  I've had clients do the same for requesting a 510(k) when the predicate device's sponsor has a 510(k) Statement instead of a Summary.  That way it comes via my letterhead instead of theirs.


-------------------------------------------
Allison Komiyama PHD, RAC
Principal
Acknowledge Regulatory Strategies
San Diego CA
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

Yes. The FDA will identify the FOIA requestor to the 510(k) holder when the 510(k) review packet is provided for removal of company confidential information.

-------------------------------------------
Gary Syring RAC
Prin Consultant
Quality & Regulatory Associates LLC
Stoughton WI
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

FOI Services has about 40,000 510(k)s that have been released under FOIA, and there's no charge to see if we have the one you need in our files already - www.foiservices.com (enter product name, company or k# in the search box). If you don't see the document you want, it's worth contacting our info specs (infoFOI@foiservices.com) to see if we've already placed a request for it; if so we can let you know when we receive it.  

Marlene

-------------------------------------------
Marlene Bobka
President
FOI Services Inc
CLARKSBURG MD
United States
-------------------------------------------


Original Message:
Sent: 04-27-2015 08:18
From: Gary Syring
Subject: 510(k) FOIA Request

Yes. The FDA will identify the FOIA requestor to the 510(k) holder when the 510(k) review packet is provided for removal of company confidential information.

-------------------------------------------
Gary Syring RAC
Prin Consultant
Quality & Regulatory Associates LLC
Stoughton WI
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

Apologies - I should have read the thread more carefully. Michael Swit already posted this information...thank you, Michael -

Marlene
-------------------------------------------
Marlene Bobka
Vice President
FOI Services Inc
CLARKSBURG MD
United States
-------------------------------------------


Original Message:
Sent: 04-27-2015 11:32
From: Marlene Bobka
Subject: 510(k) FOIA Request

FOI Services has about 40,000 510(k)s that have been released under FOIA, and there's no charge to see if we have the one you need in our files already - www.foiservices.com (enter product name, company or k# in the search box). If you don't see the document you want, it's worth contacting our info specs (infoFOI@foiservices.com) to see if we've already placed a request for it; if so we can let you know when we receive it.  

Marlene

-------------------------------------------
Marlene Bobka
President
FOI Services Inc
CLARKSBURG MD
United States
-------------------------------------------


Original Message:
Sent: 04-27-2015 08:18
From: Gary Syring
Subject: 510(k) FOIA Request

Yes. The FDA will identify the FOIA requestor to the 510(k) holder when the 510(k) review packet is provided for removal of company confidential information.

-------------------------------------------
Gary Syring RAC
Prin Consultant
Quality & Regulatory Associates LLC
Stoughton WI
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

Marlene:

You provided more detailed info!

Best,
Michael


Please follow me on LinkedIN and Twitter:
http://www.linkedin.com/in/michaelswit
https://twitter.com/FDACounsel
-------------------------------------------


Original Message:
Sent: 04-27-2015 11:36
From: Marlene Bobka
Subject: 510(k) FOIA Request


Apologies - I should have read the thread more carefully. Michael Swit already posted this information...thank you, Michael -

Marlene
-------------------------------------------
Marlene Bobka
Vice President
FOI Services Inc
CLARKSBURG MD
United States
-------------------------------------------


Original Message:
Sent: 04-27-2015 11:32
From: Marlene Bobka
Subject: 510(k) FOIA Request

FOI Services has about 40,000 510(k)s that have been released under FOIA, and there's no charge to see if we have the one you need in our files already - www.foiservices.com (enter product name, company or k# in the search box). If you don't see the document you want, it's worth contacting our info specs (infoFOI@foiservices.com) to see if we've already placed a request for it; if so we can let you know when we receive it.  

Marlene

-------------------------------------------
Marlene Bobka
President
FOI Services Inc
CLARKSBURG MD
United States
-------------------------------------------


Original Message:
Sent: 04-27-2015 08:18
From: Gary Syring
Subject: 510(k) FOIA Request

Yes. The FDA will identify the FOIA requestor to the 510(k) holder when the 510(k) review packet is provided for removal of company confidential information.

-------------------------------------------
Gary Syring RAC
Prin Consultant
Quality & Regulatory Associates LLC
Stoughton WI
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------

I will chime into say that FOI Services is much, much faster than FDA if they already have the document.

If they have requested the document from FDA, but not yet received it, they will be more or less that much faster, which is to say, if they requested it six months ago, they will be six months faster in getting it than you would be if you requested it today.

If they haven't requested the document yet, I wouldn't expect them to get it any faster than you would if you requested it yourself.

-------------------------------------------
Julie Omohundro RAC
Durham NC
United States

Original Message:
Sent: 04-27-2015 12:37
From: Michael Swit
Subject: 510(k) FOIA Request

Marlene:

You provided more detailed info!

Best,
Michael


Please follow me on LinkedIN and Twitter:
http://www.linkedin.com/in/michaelswit
https://twitter.com/FDACounsel
-------------------------------------------


Original Message:
Sent: 04-27-2015 11:36
From: Marlene Bobka
Subject: 510(k) FOIA Request


Apologies - I should have read the thread more carefully. Michael Swit already posted this information...thank you, Michael -

Marlene
-------------------------------------------
Marlene Bobka
Vice President
FOI Services Inc
CLARKSBURG MD
United States
-------------------------------------------


Original Message:
Sent: 04-27-2015 11:32
From: Marlene Bobka
Subject: 510(k) FOIA Request

FOI Services has about 40,000 510(k)s that have been released under FOIA, and there's no charge to see if we have the one you need in our files already - www.foiservices.com (enter product name, company or k# in the search box). If you don't see the document you want, it's worth contacting our info specs (infoFOI@foiservices.com) to see if we've already placed a request for it; if so we can let you know when we receive it.  

Marlene

-------------------------------------------
Marlene Bobka
President
FOI Services Inc
CLARKSBURG MD
United States
-------------------------------------------


Original Message:
Sent: 04-27-2015 08:18
From: Gary Syring
Subject: 510(k) FOIA Request

Yes. The FDA will identify the FOIA requestor to the 510(k) holder when the 510(k) review packet is provided for removal of company confidential information.

-------------------------------------------
Gary Syring RAC
Prin Consultant
Quality & Regulatory Associates LLC
Stoughton WI
United States
-------------------------------------------


Original Message:
Sent: 04-23-2015 13:30
From: Edsel Sinson
Subject: 510(k) FOIA Request

Hello, 

I am seeking a 510(k) that is not accessible online. If I request a FOI for a company's 510(k), will the FDA notify that company that I am requesting such information? 

Please advise and thank you.

-------------------------------------------
Edsel Sinson
Fullerton CA
United States
-------------------------------------------