Regulatory Open Forum

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------

If you request directly from FDA, it could take, literally, years unless what you requested has been requested before.  The requester must pay FDA, although they used to bill you, although they can request advance payment if the request is likely to be either voluminous or require considerable staff time to review for information that is exempt from disclosure.

If you are in a hurry for the information and it is possible that it has been requested before, you may be able to get what you want from a private service called FOI Services (www.foiservices.com).  If they have it in their system, can get very quick access, but it is not cheap.

Don't forget to search FDA's website first to see if what you want is not already posted on the agency's website.

Good luck,
Michael

______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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

-------------------------------------------






Original Message:
Sent: 03-17-2014 14:36
From: Shuzhi Zhang
Subject: FOIA Request Question

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------

It takes patience (months to years) to get FDA response to ask if requestor still needs the requested info.  FDA could ask the same question more than once.  If the requestor persists on the request, FDA will then proceed to search it.  Once FDA informed me that requested info could not be found in FDA databas, but sent me a copy of the requested info at N/C months later.   

For 510K submission w/ 510K statement, one may request a copy from the submitting entity, provided that it is still in buisness. The entity must provide a copy of said 510K submisison (except confidential info) within 30 days after receipt of a request. If one requests it from FDA, received copy of 510K file includes all FDA review notes, etc. though it takes long time.

Once a medical device manufacturer received a complete copy of a 510K file from FDA, and was asked to black out confidential info within 30 days. That was for a FOIA request dated 2 years earlier.  

Yi Chen, PhD, RAC
Westlake Village, CA
United States
-------------------------------------------






Original Message:
Sent: 03-17-2014 14:56
From: Michael Swit
Subject: FOIA Request Question

If you request directly from FDA, it could take, literally, years unless what you requested has been requested before.  The requester must pay FDA, although they used to bill you, although they can request advance payment if the request is likely to be either voluminous or require considerable staff time to review for information that is exempt from disclosure.

If you are in a hurry for the information and it is possible that it has been requested before, you may be able to get what you want from a private service called FOI Services (www.foiservices.com).  If they have it in their system, can get very quick access, but it is not cheap.

Don't forget to search FDA's website first to see if what you want is not already posted on the agency's website.

Good luck,
Michael

______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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

-------------------------------------------






Original Message:
Sent: 03-17-2014 14:36
From: Shuzhi Zhang
Subject: FOIA Request Question

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------

Hi Yi,
Thanks for the reply. You mentioned that request can be sent to the submitting institute, do you know how to do this (by doing this, the submitting institute will know who is the competitor, right?) ?
Best regards,
Shuzhi
-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------






Original Message:
Sent: 03-18-2014 02:44
From: Yi Chen
Subject: FOIA Request Question

It takes patience (months to years) to get FDA response to ask if requestor still needs the requested info.  FDA could ask the same question more than once.  If the requestor persists on the request, FDA will then proceed to search it.  Once FDA informed me that requested info could not be found in FDA databas, but sent me a copy of the requested info at N/C months later.   

For 510K submission w/ 510K statement, one may request a copy from the submitting entity, provided that it is still in buisness. The entity must provide a copy of said 510K submisison (except confidential info) within 30 days after receipt of a request. If one requests it from FDA, received copy of 510K file includes all FDA review notes, etc. though it takes long time.

Once a medical device manufacturer received a complete copy of a 510K file from FDA, and was asked to black out confidential info within 30 days. That was for a FOIA request dated 2 years earlier.  

Yi Chen, PhD, RAC
Westlake Village, CA
United States
-------------------------------------------






Original Message:
Sent: 03-17-2014 14:56
From: Michael Swit
Subject: FOIA Request Question

If you request directly from FDA, it could take, literally, years unless what you requested has been requested before.  The requester must pay FDA, although they used to bill you, although they can request advance payment if the request is likely to be either voluminous or require considerable staff time to review for information that is exempt from disclosure.

If you are in a hurry for the information and it is possible that it has been requested before, you may be able to get what you want from a private service called FOI Services (www.foiservices.com).  If they have it in their system, can get very quick access, but it is not cheap.

Don't forget to search FDA's website first to see if what you want is not already posted on the agency's website.

Good luck,
Michael

______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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

-------------------------------------------






Original Message:
Sent: 03-17-2014 14:36
From: Shuzhi Zhang
Subject: FOIA Request Question

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------

Hi Michael,
Thanks so much for your detail information. I just wonder how much the original 510(k) would help, even I can get it soon. Do you know what kind of information will be omitted usually? Thank you for your time.
Best regards,
Shuzhi
-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------






Original Message:
Sent: 03-17-2014 14:56
From: Michael Swit
Subject: FOIA Request Question

If you request directly from FDA, it could take, literally, years unless what you requested has been requested before.  The requester must pay FDA, although they used to bill you, although they can request advance payment if the request is likely to be either voluminous or require considerable staff time to review for information that is exempt from disclosure.

If you are in a hurry for the information and it is possible that it has been requested before, you may be able to get what you want from a private service called FOI Services (www.foiservices.com).  If they have it in their system, can get very quick access, but it is not cheap.

Don't forget to search FDA's website first to see if what you want is not already posted on the agency's website.

Good luck,
Michael

______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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

-------------------------------------------






Original Message:
Sent: 03-17-2014 14:36
From: Shuzhi Zhang
Subject: FOIA Request Question

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------

I have not seen a 510(k) that had been redacted under the FOI process in some time.  However, typically, what is subject to redaaction is any information that is trade secret (e.g., manufacturing processes) or that identifies a human subject.  You can find more information on what is exempt from disclosure under FOI by
reviewing FDA's FOI regulations at 21 CFR Part 20, specifically 20.60 to 20.67.


______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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

-------------------------------------------






Original Message:
Sent: 03-20-2014 15:06
From: Shuzhi Zhang
Subject: FOIA Request Question


Hi Michael,
Thanks so much for your detail information. I just wonder how much the original 510(k) would help, even I can get it soon. Do you know what kind of information will be omitted usually? Thank you for your time.
Best regards,
Shuzhi
-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------






Original Message:
Sent: 03-17-2014 14:56
From: Michael Swit
Subject: FOIA Request Question

If you request directly from FDA, it could take, literally, years unless what you requested has been requested before.  The requester must pay FDA, although they used to bill you, although they can request advance payment if the request is likely to be either voluminous or require considerable staff time to review for information that is exempt from disclosure.

If you are in a hurry for the information and it is possible that it has been requested before, you may be able to get what you want from a private service called FOI Services (www.foiservices.com).  If they have it in their system, can get very quick access, but it is not cheap.

Don't forget to search FDA's website first to see if what you want is not already posted on the agency's website.

Good luck,
Michael

______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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

-------------------------------------------






Original Message:
Sent: 03-17-2014 14:36
From: Shuzhi Zhang
Subject: FOIA Request Question

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------

There are companies out there that have already acquired 510k's via the FOI Act that are available immediately for purchase.  Have you tried them yet?  You can just do an internet search and find them pretty easily.  Once on their site, you can search what 510k's they have.  I have used it in the past and they had several of the submissions that I needed.  For my needs, the necessary information was still included.  Good luck.
-------------------------------------------
Paul Vagts
Parcus Medical
Sarasota FL
United States
-------------------------------------------






Original Message:
Sent: 03-20-2014 15:19
From: Michael Swit
Subject: FOIA Request Question


I have not seen a 510(k) that had been redacted under the FOI process in some time.  However, typically, what is subject to redaaction is any information that is trade secret (e.g., manufacturing processes) or that identifies a human subject.  You can find more information on what is exempt from disclosure under FOI by
reviewing FDA's FOI regulations at 21 CFR Part 20, specifically 20.60 to 20.67.


______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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

-------------------------------------------






Original Message:
Sent: 03-20-2014 15:06
From: Shuzhi Zhang
Subject: FOIA Request Question


Hi Michael,
Thanks so much for your detail information. I just wonder how much the original 510(k) would help, even I can get it soon. Do you know what kind of information will be omitted usually? Thank you for your time.
Best regards,
Shuzhi
-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------






Original Message:
Sent: 03-17-2014 14:56
From: Michael Swit
Subject: FOIA Request Question

If you request directly from FDA, it could take, literally, years unless what you requested has been requested before.  The requester must pay FDA, although they used to bill you, although they can request advance payment if the request is likely to be either voluminous or require considerable staff time to review for information that is exempt from disclosure.

If you are in a hurry for the information and it is possible that it has been requested before, you may be able to get what you want from a private service called FOI Services (www.foiservices.com).  If they have it in their system, can get very quick access, but it is not cheap.

Don't forget to search FDA's website first to see if what you want is not already posted on the agency's website.

Good luck,
Michael

______________________________________________
Michael A. Swit, Esq.
Special Counsel, FDA Law Practice
Duane Morris LLP
750 B Street, Suite 2900
San Diego, CA 92101-4681
P: +1 619 744 2215
F: +1 619 923 2648
C +1 760 815 4762
maswit@duanemorris.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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

-------------------------------------------






Original Message:
Sent: 03-17-2014 14:36
From: Shuzhi Zhang
Subject: FOIA Request Question

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------

Hi Shuzhi,
The Government will be more than happy to bill you after they see how long it takes to retrieve the information. As for the timing, I've had then take a few weeks and I've had some (from the same request) take 6 months. It depends on who is storing the data and how busy they are.

Good luck!
Robin

-------------------------------------------
Robin Guy MS, DABT, RQAP-GLP
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
United States
-------------------------------------------






Original Message:
Sent: 03-17-2014 14:36
From: Shuzhi Zhang
Subject: FOIA Request Question

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------

My experience has been 1 - 3 years. And I haven't had good luck calling to find the status on a request.

-------------------------------------------
Corey Jaseph RAC
Regulatory Affairs Manager
Ultradent Products, Inc.
South Jordan UT
United States
-------------------------------------------






Original Message:
Sent: 03-18-2014 08:03
From: Robin Guy
Subject: FOIA Request Question

Hi Shuzhi,
The Government will be more than happy to bill you after they see how long it takes to retrieve the information. As for the timing, I've had then take a few weeks and I've had some (from the same request) take 6 months. It depends on who is storing the data and how busy they are.

Good luck!
Robin

-------------------------------------------
Robin Guy MS, DABT, RQAP-GLP
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
United States
-------------------------------------------






Original Message:
Sent: 03-17-2014 14:36
From: Shuzhi Zhang
Subject: FOIA Request Question

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------

Hi Corey,
Thanks for your information. Sorry about your previous request experience, but that is FDA, you know that. :)
Best regards,
Shuzhi

-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------






Original Message:
Sent: 03-18-2014 09:58
From: Corey Jaseph
Subject: FOIA Request Question

My experience has been 1 - 3 years. And I haven't had good luck calling to find the status on a request.

-------------------------------------------
Corey Jaseph RAC
Regulatory Affairs Manager
Ultradent Products, Inc.
South Jordan UT
United States
-------------------------------------------






Original Message:
Sent: 03-18-2014 08:03
From: Robin Guy
Subject: FOIA Request Question

Hi Shuzhi,
The Government will be more than happy to bill you after they see how long it takes to retrieve the information. As for the timing, I've had then take a few weeks and I've had some (from the same request) take 6 months. It depends on who is storing the data and how busy they are.

Good luck!
Robin

-------------------------------------------
Robin Guy MS, DABT, RQAP-GLP
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
United States
-------------------------------------------






Original Message:
Sent: 03-17-2014 14:36
From: Shuzhi Zhang
Subject: FOIA Request Question

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------

Hi Robin,
Thanks for the reply. May I ask what was the most expensive FOI you ever requested?
Best regards,
Shuzhi

-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------






Original Message:
Sent: 03-18-2014 08:03
From: Robin Guy
Subject: FOIA Request Question

Hi Shuzhi,
The Government will be more than happy to bill you after they see how long it takes to retrieve the information. As for the timing, I've had then take a few weeks and I've had some (from the same request) take 6 months. It depends on who is storing the data and how busy they are.

Good luck!
Robin

-------------------------------------------
Robin Guy MS, DABT, RQAP-GLP
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
Lake Forest IL
United States
-------------------------------------------






Original Message:
Sent: 03-17-2014 14:36
From: Shuzhi Zhang
Subject: FOIA Request Question

Hi All,
Is anyone familiar with the FOIA process? Is payment required to FDA or the company? How long does the process take? Thanks!


-------------------------------------------
Shuzhi Zhang
Malden MA
United States
-------------------------------------------