Regulatory Open Forum

Many of you probably do this, but for newer device RA folks, I want to strongly encourage you to use FOIA to request copies of your own 510(k)s. Why would you want to do this when you diligently kept copies of your submissions and correspondence you may ask?

Because with FOIA, you get not only your files, but also copies of the FDA review memos and consult opinions. These can be very informative - what topics were discussed? which ones appears to be controversial? when did the lead reviewer (or up the line) obviously decide input from a consult was "over the line," did anyone read your "history of unreported changes" section?

We've made this our standard practice - you can send in the request as soon as you get clearance and they come pretty quickly because no redaction time is needed (since it is your file). We've even found instances where what FDA told us during the review directly contradicts what is in the file and at least once were basically able to pick out a "last minute" labeling change that came up the line at Branch Chief or Division review - which helps to understand who the players are and how they interact.

The insights you get may help you as you plan your next project/submission.

g-

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

Original Message------

Many of you probably do this, but for newer device RA folks, I want to strongly encourage you to use FOIA to request copies of your own 510(k)s. Why would you want to do this when you diligently kept copies of your submissions and correspondence you may ask?

Because with FOIA, you get not only your files, but also copies of the FDA review memos and consult opinions. These can be very informative - what topics were discussed? which ones appears to be controversial? when did the lead reviewer (or up the line) obviously decide input from a consult was "over the line," did anyone read your "history of unreported changes" section?

We've made this our standard practice - you can send in the request as soon as you get clearance and they come pretty quickly because no redaction time is needed (since it is your file). We've even found instances where what FDA told us during the review directly contradicts what is in the file and at least once were basically able to pick out a "last minute" labeling change that came up the line at Branch Chief or Division review - which helps to understand who the players are and how they interact.

The insights you get may help you as you plan your next project/submission.

g-

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

Completely agree ... thanks for the very sound advice Ginger.

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

Original Message:
Sent: 30-Jun-2018 10:42
From: John Beasley
Subject: FOAI Suggestion

Hi Ginger,

Really good advice.  Don't forget that FDA has an electronic ready room which contains all previous FOIA requests and information provided.  So, if you are looking for something historical, rummage through the reading room materials for what you need, before making the FOIA request - it may be there!

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

Many of you probably do this, but for newer device RA folks, I want to strongly encourage you to use FOIA to request copies of your own 510(k)s. Why would you want to do this when you diligently kept copies of your submissions and correspondence you may ask?

Because with FOIA, you get not only your files, but also copies of the FDA review memos and consult opinions. These can be very informative - what topics were discussed? which ones appears to be controversial? when did the lead reviewer (or up the line) obviously decide input from a consult was "over the line," did anyone read your "history of unreported changes" section?

We've made this our standard practice - you can send in the request as soon as you get clearance and they come pretty quickly because no redaction time is needed (since it is your file). We've even found instances where what FDA told us during the review directly contradicts what is in the file and at least once were basically able to pick out a "last minute" labeling change that came up the line at Branch Chief or Division review - which helps to understand who the players are and how they interact.

The insights you get may help you as you plan your next project/submission.

g-

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

This message was posted by a user wishing to remain anonymous

I submitted an FOI request for a copy of written feedback from FDA to my employer for an older pre-sub that was submitted prior to my employment at this company. That was back in April. I have not received anything yet.
Original Message:
Sent: 01-Jul-2018 16:17
From: Richard Vincins
Subject: FOAI Suggestion

Completely agree ... thanks for the very sound advice Ginger.

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

Original Message:
Sent: 30-Jun-2018 10:42
From: John Beasley
Subject: FOAI Suggestion

Hi Ginger,

Really good advice.  Don't forget that FDA has an electronic ready room which contains all previous FOIA requests and information provided.  So, if you are looking for something historical, rummage through the reading room materials for what you need, before making the FOIA request - it may be there!

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

Many of you probably do this, but for newer device RA folks, I want to strongly encourage you to use FOIA to request copies of your own 510(k)s. Why would you want to do this when you diligently kept copies of your submissions and correspondence you may ask?

Because with FOIA, you get not only your files, but also copies of the FDA review memos and consult opinions. These can be very informative - what topics were discussed? which ones appears to be controversial? when did the lead reviewer (or up the line) obviously decide input from a consult was "over the line," did anyone read your "history of unreported changes" section?

We've made this our standard practice - you can send in the request as soon as you get clearance and they come pretty quickly because no redaction time is needed (since it is your file). We've even found instances where what FDA told us during the review directly contradicts what is in the file and at least once were basically able to pick out a "last minute" labeling change that came up the line at Branch Chief or Division review - which helps to understand who the players are and how they interact.

The insights you get may help you as you plan your next project/submission.

g-

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

Even when there is no redaction required, it can take some time to receive the requested documents.  When we send an FOIA request, we will ask for a status at regular intervals.  Not so often that it is annoying to the FOIA staff (they have an incredible workload), but frequent enough to know that you are paying attention to the time.  Our own experience with the length of time for getting documents of this type is within 90 days.

Another note for those looking for documents that are NOT your own that I did not see mentioned in this thread - go to foiservices.com and see if they have it in their library.  If they do, you can purchase it on the spot.  Much better than waiting for months or even years to get something through the FOIA request process.

Cheers,
Melissa


------------------------------
Melissa Walker RAC
President & CTO
St Louis MO
United States
------------------------------

Original Message:
Sent: 02-Jul-2018 10:35
From: Anonymous Member
Subject: FOAI Suggestion

This message was posted by a user wishing to remain anonymous

I submitted an FOI request for a copy of written feedback from FDA to my employer for an older pre-sub that was submitted prior to my employment at this company. That was back in April. I have not received anything yet.
Original Message:
Sent: 01-Jul-2018 16:17
From: Richard Vincins
Subject: FOAI Suggestion

Completely agree ... thanks for the very sound advice Ginger.

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

Original Message:
Sent: 30-Jun-2018 10:42
From: John Beasley
Subject: FOAI Suggestion

Hi Ginger,

Really good advice.  Don't forget that FDA has an electronic ready room which contains all previous FOIA requests and information provided.  So, if you are looking for something historical, rummage through the reading room materials for what you need, before making the FOIA request - it may be there!

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

Many of you probably do this, but for newer device RA folks, I want to strongly encourage you to use FOIA to request copies of your own 510(k)s. Why would you want to do this when you diligently kept copies of your submissions and correspondence you may ask?

Because with FOIA, you get not only your files, but also copies of the FDA review memos and consult opinions. These can be very informative - what topics were discussed? which ones appears to be controversial? when did the lead reviewer (or up the line) obviously decide input from a consult was "over the line," did anyone read your "history of unreported changes" section?

We've made this our standard practice - you can send in the request as soon as you get clearance and they come pretty quickly because no redaction time is needed (since it is your file). We've even found instances where what FDA told us during the review directly contradicts what is in the file and at least once were basically able to pick out a "last minute" labeling change that came up the line at Branch Chief or Division review - which helps to understand who the players are and how they interact.

The insights you get may help you as you plan your next project/submission.

g-

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

Unfortunately, "older pre-subs" tend to take a long time. FDA claims that this was because they had to track them by hand and not in their electronic tracking system. Hopefully they will hunt it down and get it to you soon.

g-

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

Original Message:
Sent: 02-Jul-2018 10:35
From: Anonymous Member
Subject: FOAI Suggestion

This message was posted by a user wishing to remain anonymous

I submitted an FOI request for a copy of written feedback from FDA to my employer for an older pre-sub that was submitted prior to my employment at this company. That was back in April. I have not received anything yet.
Original Message:
Sent: 01-Jul-2018 16:17
From: Richard Vincins
Subject: FOAI Suggestion

Completely agree ... thanks for the very sound advice Ginger.

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

Original Message:
Sent: 30-Jun-2018 10:42
From: John Beasley
Subject: FOAI Suggestion

Hi Ginger,

Really good advice.  Don't forget that FDA has an electronic ready room which contains all previous FOIA requests and information provided.  So, if you are looking for something historical, rummage through the reading room materials for what you need, before making the FOIA request - it may be there!

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

Many of you probably do this, but for newer device RA folks, I want to strongly encourage you to use FOIA to request copies of your own 510(k)s. Why would you want to do this when you diligently kept copies of your submissions and correspondence you may ask?

Because with FOIA, you get not only your files, but also copies of the FDA review memos and consult opinions. These can be very informative - what topics were discussed? which ones appears to be controversial? when did the lead reviewer (or up the line) obviously decide input from a consult was "over the line," did anyone read your "history of unreported changes" section?

We've made this our standard practice - you can send in the request as soon as you get clearance and they come pretty quickly because no redaction time is needed (since it is your file). We've even found instances where what FDA told us during the review directly contradicts what is in the file and at least once were basically able to pick out a "last minute" labeling change that came up the line at Branch Chief or Division review - which helps to understand who the players are and how they interact.

The insights you get may help you as you plan your next project/submission.

g-

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

Great information Ginger.  So grateful for your advice because this is my first experience with FOIA requests.  

Thank you!


Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 03-Jul-2018 08:39
From: Ginger Glaser
Subject: FOAI Suggestion

Unfortunately, "older pre-subs" tend to take a long time. FDA claims that this was because they had to track them by hand and not in their electronic tracking system. Hopefully they will hunt it down and get it to you soon.

g-

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

Original Message:
Sent: 02-Jul-2018 10:35
From: Anonymous Member
Subject: FOAI Suggestion

This message was posted by a user wishing to remain anonymous

I submitted an FOI request for a copy of written feedback from FDA to my employer for an older pre-sub that was submitted prior to my employment at this company. That was back in April. I have not received anything yet.
Original Message:
Sent: 01-Jul-2018 16:17
From: Richard Vincins
Subject: FOAI Suggestion

Completely agree ... thanks for the very sound advice Ginger.

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

Original Message:
Sent: 30-Jun-2018 10:42
From: John Beasley
Subject: FOAI Suggestion

Hi Ginger,

Really good advice.  Don't forget that FDA has an electronic ready room which contains all previous FOIA requests and information provided.  So, if you are looking for something historical, rummage through the reading room materials for what you need, before making the FOIA request - it may be there!

Sincerely,

John Beasley, RAC (US)
Founding Member and Senior Consultant
MedTech Review, LLC
www.medtechreview.com
www.linkedin.com/in/medtechreview





257 Garnet Garden Street
Henderson, NV 89015

USA:  +1 612-889-5168
SKYPE:   medtechreview

All views given by MedTech Review consultants on the interpretation of medical device regulations represent our best judgment at the time. Such views are not meant to be a definitive statement of law and we would advise you to seek the views of your own professional advisors. 

This electronic transmission is strictly confidential between the sender and the intended addressee.  It may contain information which is covered by legal, professional or other privilege. If you are not the intended addressee, or someone authorized by the intended addressee to receive transmissions on their behalf, you must not retain, disclose in any form, copy or take any action in reliance on this transmission. If you have received this transmission in error, please notify MedTech Review, LLC as soon as possible and destroy this message.

Original Message------

Many of you probably do this, but for newer device RA folks, I want to strongly encourage you to use FOIA to request copies of your own 510(k)s. Why would you want to do this when you diligently kept copies of your submissions and correspondence you may ask?

Because with FOIA, you get not only your files, but also copies of the FDA review memos and consult opinions. These can be very informative - what topics were discussed? which ones appears to be controversial? when did the lead reviewer (or up the line) obviously decide input from a consult was "over the line," did anyone read your "history of unreported changes" section?

We've made this our standard practice - you can send in the request as soon as you get clearance and they come pretty quickly because no redaction time is needed (since it is your file). We've even found instances where what FDA told us during the review directly contradicts what is in the file and at least once were basically able to pick out a "last minute" labeling change that came up the line at Branch Chief or Division review - which helps to understand who the players are and how they interact.

The insights you get may help you as you plan your next project/submission.

g-

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