Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Does anyone know what is the best way to send response to FDA 483?
-Mail
-Email
-Fax
-ESG

what in case if file exceeds the size to be sent through email? (i.e.) more than 50 mb

Thank you for your help.

 

​I have always seen written responses that were sent via FedEx. You want to have traceability that you responded. It doesn't hurt to also follow up to confirm that FDA received your response.

Regards

------------------------------
Christine Anderson
Senior Principal Specialist
Regulatory & Quality Solutions
------------------------------

Original Message:
Sent: 19-Jun-2018 10:11
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

Does anyone know what is the best way to send response to FDA 483?
-Mail
-Email
-Fax
-ESG

what in case if file exceeds the size to be sent through email? (i.e.) more than 50 mb

Thank you for your help.

 

This message was posted by a user wishing to remain anonymous

What in case if response(50+mb) has hyperlinks and bookmarks and it is recommended to send electronically instead of normal mail.

Does FDA accepts documents through FTP?
Original Message:
Sent: 19-Jun-2018 10:49
From: Christine Anderson
Subject: Response to 483

​I have always seen written responses that were sent via FedEx. You want to have traceability that you responded. It doesn't hurt to also follow up to confirm that FDA received your response.

Regards

------------------------------
Christine Anderson
Senior Principal Specialist
Regulatory & Quality Solutions

Original Message:
Sent: 19-Jun-2018 10:11
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

Does anyone know what is the best way to send response to FDA 483?
-Mail
-Email
-Fax
-ESG

what in case if file exceeds the size to be sent through email? (i.e.) more than 50 mb

Thank you for your help.

 

What Christine recommended is the best approach; send in a hard copy with tracking to confirm receipt.

Regarding electronic submission; as far as I know for FDA Form 483 responses from a completed inspection FDA does not accept electronic submission.  In fact, the response to Form 483 should be done to local FDA district office (D.C. for foreign inspections) and they may not have capability to record information in an electronic system like eCopy for 510(k) submissions.

In my experience, FDA does not accept documents through FTP or any other file-sharing system because the government system needs to be protected from viruses, intrusions, etc.  I tried to share a large file with an FDA reviewer a while back and I ended having to send in a Supplement with the file on a CD/DVD.

Now this does not mean you could have a conversation with the local FDA district office to inquire if they will accept an electronic version of the Form 483 response through email or some other medium.  Nowadays, they may do this but it would be dependent upon the district office I think and what capability they have to accept electronic only responses.

Worse comes to worse if you have an electronic version with hyperlinks and bookmarks, send in a hard copy + CD/DVD with the electronic version.  In the cover letter to the Form 483 response explain that the CD/DVD has an electronic version that is navigable with hyperlinks and bookmarks.

I would be curious if the wider RAPS group has ever submitted electronic Form 483 responses that have been accepted.

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

Original Message:
Sent: 19-Jun-2018 11:22
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

What in case if response(50+mb) has hyperlinks and bookmarks and it is recommended to send electronically instead of normal mail.

Does FDA accepts documents through FTP?
Original Message:
Sent: 19-Jun-2018 10:49
From: Christine Anderson
Subject: Response to 483

​I have always seen written responses that were sent via FedEx. You want to have traceability that you responded. It doesn't hurt to also follow up to confirm that FDA received your response.

Regards

------------------------------
Christine Anderson
Senior Principal Specialist
Regulatory & Quality Solutions

Original Message:
Sent: 19-Jun-2018 10:11
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

Does anyone know what is the best way to send response to FDA 483?
-Mail
-Email
-Fax
-ESG

what in case if file exceeds the size to be sent through email? (i.e.) more than 50 mb

Thank you for your help.

 

In our 820 inspection last August, the inspector actually requested that we send the response electronically and indicated that email is the preferred method for responses.

When we emailed our response, we received an automated response indicating that the FDA had received our response for our records. Received our EIR in record time.

------------------------------
Joshua Lust
Global Regulatory Affairs Manager
Grand Rapids MI
United States
------------------------------

Original Message:
Sent: 20-Jun-2018 04:31
From: Richard Vincins
Subject: Response to 483

What Christine recommended is the best approach; send in a hard copy with tracking to confirm receipt.

Regarding electronic submission; as far as I know for FDA Form 483 responses from a completed inspection FDA does not accept electronic submission.  In fact, the response to Form 483 should be done to local FDA district office (D.C. for foreign inspections) and they may not have capability to record information in an electronic system like eCopy for 510(k) submissions.

In my experience, FDA does not accept documents through FTP or any other file-sharing system because the government system needs to be protected from viruses, intrusions, etc.  I tried to share a large file with an FDA reviewer a while back and I ended having to send in a Supplement with the file on a CD/DVD.

Now this does not mean you could have a conversation with the local FDA district office to inquire if they will accept an electronic version of the Form 483 response through email or some other medium.  Nowadays, they may do this but it would be dependent upon the district office I think and what capability they have to accept electronic only responses.

Worse comes to worse if you have an electronic version with hyperlinks and bookmarks, send in a hard copy + CD/DVD with the electronic version.  In the cover letter to the Form 483 response explain that the CD/DVD has an electronic version that is navigable with hyperlinks and bookmarks.

I would be curious if the wider RAPS group has ever submitted electronic Form 483 responses that have been accepted.

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

Original Message:
Sent: 19-Jun-2018 11:22
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

What in case if response(50+mb) has hyperlinks and bookmarks and it is recommended to send electronically instead of normal mail.

Does FDA accepts documents through FTP?
Original Message:
Sent: 19-Jun-2018 10:49
From: Christine Anderson
Subject: Response to 483

​I have always seen written responses that were sent via FedEx. You want to have traceability that you responded. It doesn't hurt to also follow up to confirm that FDA received your response.

Regards

------------------------------
Christine Anderson
Senior Principal Specialist
Regulatory & Quality Solutions

Original Message:
Sent: 19-Jun-2018 10:11
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

Does anyone know what is the best way to send response to FDA 483?
-Mail
-Email
-Fax
-ESG

what in case if file exceeds the size to be sent through email? (i.e.) more than 50 mb

Thank you for your help.

 

With the recent ORA reorganization, FDA is now saying (in a few recent trade press articles and presentations) you should send 483 responses in both email and paper copy. The email address for devices is

Division 1: oradevices1firmresponse@fda.hhs.gov
Division 2: oradevices2firmresponse@fda.hhs.gov
Division 3: oradevices3firmresponse@fda.hhs.gov

The paper copy, oddly, should go to the Division Director in your old District office w/ Attn: Compliance on the letter. The electronic copy is now consider the "official" response. In fact FDA says they would prefer you not send paper copies but they realize that isn't going to happen :-)

I'd suggest you reach out to the Division Program Director and ask how they would prefer to receive a response that is too big for email - after first trying like crazy to actually get the response compressed down to be able to be sent via email. Be prepared to suggest a lot of possibilities, including sending it to them on a CD etc.

Ginger

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

Original Message:
Sent: 20-Jun-2018 04:31
From: Richard Vincins
Subject: Response to 483

What Christine recommended is the best approach; send in a hard copy with tracking to confirm receipt.

Regarding electronic submission; as far as I know for FDA Form 483 responses from a completed inspection FDA does not accept electronic submission.  In fact, the response to Form 483 should be done to local FDA district office (D.C. for foreign inspections) and they may not have capability to record information in an electronic system like eCopy for 510(k) submissions.

In my experience, FDA does not accept documents through FTP or any other file-sharing system because the government system needs to be protected from viruses, intrusions, etc.  I tried to share a large file with an FDA reviewer a while back and I ended having to send in a Supplement with the file on a CD/DVD.

Now this does not mean you could have a conversation with the local FDA district office to inquire if they will accept an electronic version of the Form 483 response through email or some other medium.  Nowadays, they may do this but it would be dependent upon the district office I think and what capability they have to accept electronic only responses.

Worse comes to worse if you have an electronic version with hyperlinks and bookmarks, send in a hard copy + CD/DVD with the electronic version.  In the cover letter to the Form 483 response explain that the CD/DVD has an electronic version that is navigable with hyperlinks and bookmarks.

I would be curious if the wider RAPS group has ever submitted electronic Form 483 responses that have been accepted.

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

Original Message:
Sent: 19-Jun-2018 11:22
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

What in case if response(50+mb) has hyperlinks and bookmarks and it is recommended to send electronically instead of normal mail.

Does FDA accepts documents through FTP?
Original Message:
Sent: 19-Jun-2018 10:49
From: Christine Anderson
Subject: Response to 483

​I have always seen written responses that were sent via FedEx. You want to have traceability that you responded. It doesn't hurt to also follow up to confirm that FDA received your response.

Regards

------------------------------
Christine Anderson
Senior Principal Specialist
Regulatory & Quality Solutions

Original Message:
Sent: 19-Jun-2018 10:11
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

Does anyone know what is the best way to send response to FDA 483?
-Mail
-Email
-Fax
-ESG

what in case if file exceeds the size to be sent through email? (i.e.) more than 50 mb

Thank you for your help.

 

This message was posted by a user wishing to remain anonymous

Thank you for taking the time to share all of that great information. Your inputs and advice have been extremely helpful.
Original Message:
Sent: 20-Jun-2018 08:24
From: Ginger Glaser
Subject: Response to 483

With the recent ORA reorganization, FDA is now saying (in a few recent trade press articles and presentations) you should send 483 responses in both email and paper copy. The email address for devices is

Division 1: oradevices1firmresponse@fda.hhs.gov
Division 2: oradevices2firmresponse@fda.hhs.gov
Division 3: oradevices3firmresponse@fda.hhs.gov

The paper copy, oddly, should go to the Division Director in your old District office w/ Attn: Compliance on the letter. The electronic copy is now consider the "official" response. In fact FDA says they would prefer you not send paper copies but they realize that isn't going to happen :-)

I'd suggest you reach out to the Division Program Director and ask how they would prefer to receive a response that is too big for email - after first trying like crazy to actually get the response compressed down to be able to be sent via email. Be prepared to suggest a lot of possibilities, including sending it to them on a CD etc.

Ginger

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

Original Message:
Sent: 20-Jun-2018 04:31
From: Richard Vincins
Subject: Response to 483

What Christine recommended is the best approach; send in a hard copy with tracking to confirm receipt.

Regarding electronic submission; as far as I know for FDA Form 483 responses from a completed inspection FDA does not accept electronic submission.  In fact, the response to Form 483 should be done to local FDA district office (D.C. for foreign inspections) and they may not have capability to record information in an electronic system like eCopy for 510(k) submissions.

In my experience, FDA does not accept documents through FTP or any other file-sharing system because the government system needs to be protected from viruses, intrusions, etc.  I tried to share a large file with an FDA reviewer a while back and I ended having to send in a Supplement with the file on a CD/DVD.

Now this does not mean you could have a conversation with the local FDA district office to inquire if they will accept an electronic version of the Form 483 response through email or some other medium.  Nowadays, they may do this but it would be dependent upon the district office I think and what capability they have to accept electronic only responses.

Worse comes to worse if you have an electronic version with hyperlinks and bookmarks, send in a hard copy + CD/DVD with the electronic version.  In the cover letter to the Form 483 response explain that the CD/DVD has an electronic version that is navigable with hyperlinks and bookmarks.

I would be curious if the wider RAPS group has ever submitted electronic Form 483 responses that have been accepted.

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

Original Message:
Sent: 19-Jun-2018 11:22
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

What in case if response(50+mb) has hyperlinks and bookmarks and it is recommended to send electronically instead of normal mail.

Does FDA accepts documents through FTP?
Original Message:
Sent: 19-Jun-2018 10:49
From: Christine Anderson
Subject: Response to 483

​I have always seen written responses that were sent via FedEx. You want to have traceability that you responded. It doesn't hurt to also follow up to confirm that FDA received your response.

Regards

------------------------------
Christine Anderson
Senior Principal Specialist
Regulatory & Quality Solutions

Original Message:
Sent: 19-Jun-2018 10:11
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

Does anyone know what is the best way to send response to FDA 483?
-Mail
-Email
-Fax
-ESG

what in case if file exceeds the size to be sent through email? (i.e.) more than 50 mb

Thank you for your help.

 

Yes, thank you for this information especially what you had included Ginger - very interesting.  I had worked with a couple local districts that maybe were still "old school" wanting paper or maybe they were just saying that was the official response and I was hearing them say that as please send in paper copies haha.

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

Original Message:
Sent: 20-Jun-2018 10:10
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

Thank you for taking the time to share all of that great information. Your inputs and advice have been extremely helpful.
Original Message:
Sent: 20-Jun-2018 08:24
From: Ginger Glaser
Subject: Response to 483

With the recent ORA reorganization, FDA is now saying (in a few recent trade press articles and presentations) you should send 483 responses in both email and paper copy. The email address for devices is

Division 1: oradevices1firmresponse@fda.hhs.gov
Division 2: oradevices2firmresponse@fda.hhs.gov
Division 3: oradevices3firmresponse@fda.hhs.gov

The paper copy, oddly, should go to the Division Director in your old District office w/ Attn: Compliance on the letter. The electronic copy is now consider the "official" response. In fact FDA says they would prefer you not send paper copies but they realize that isn't going to happen :-)

I'd suggest you reach out to the Division Program Director and ask how they would prefer to receive a response that is too big for email - after first trying like crazy to actually get the response compressed down to be able to be sent via email. Be prepared to suggest a lot of possibilities, including sending it to them on a CD etc.

Ginger

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

Original Message:
Sent: 20-Jun-2018 04:31
From: Richard Vincins
Subject: Response to 483

What Christine recommended is the best approach; send in a hard copy with tracking to confirm receipt.

Regarding electronic submission; as far as I know for FDA Form 483 responses from a completed inspection FDA does not accept electronic submission.  In fact, the response to Form 483 should be done to local FDA district office (D.C. for foreign inspections) and they may not have capability to record information in an electronic system like eCopy for 510(k) submissions.

In my experience, FDA does not accept documents through FTP or any other file-sharing system because the government system needs to be protected from viruses, intrusions, etc.  I tried to share a large file with an FDA reviewer a while back and I ended having to send in a Supplement with the file on a CD/DVD.

Now this does not mean you could have a conversation with the local FDA district office to inquire if they will accept an electronic version of the Form 483 response through email or some other medium.  Nowadays, they may do this but it would be dependent upon the district office I think and what capability they have to accept electronic only responses.

Worse comes to worse if you have an electronic version with hyperlinks and bookmarks, send in a hard copy + CD/DVD with the electronic version.  In the cover letter to the Form 483 response explain that the CD/DVD has an electronic version that is navigable with hyperlinks and bookmarks.

I would be curious if the wider RAPS group has ever submitted electronic Form 483 responses that have been accepted.

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

Original Message:
Sent: 19-Jun-2018 11:22
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

What in case if response(50+mb) has hyperlinks and bookmarks and it is recommended to send electronically instead of normal mail.

Does FDA accepts documents through FTP?
Original Message:
Sent: 19-Jun-2018 10:49
From: Christine Anderson
Subject: Response to 483

​I have always seen written responses that were sent via FedEx. You want to have traceability that you responded. It doesn't hurt to also follow up to confirm that FDA received your response.

Regards

------------------------------
Christine Anderson
Senior Principal Specialist
Regulatory & Quality Solutions

Original Message:
Sent: 19-Jun-2018 10:11
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

Does anyone know what is the best way to send response to FDA 483?
-Mail
-Email
-Fax
-ESG

what in case if file exceeds the size to be sent through email? (i.e.) more than 50 mb

Thank you for your help.

 

Richard,

I too have always done responses like you describe - with the official copy in paper and tracked receipt. That's actually why I flagged the new FDA info. All apparently driven by the new ORA structure and the desire for them to have an "all electronic" system that automatically (or semi-automatically) incorporates the official responses. I am told those email addresses should route responses directly into the official files eventually - though I suspect right now someone still has to match them up with the company.

I do generally like electronic overall though.

We actually added these to our SOPs, just so we remember to use them if the need ever arises! I hope I won't ever again need them :-)

G-

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

Original Message:
Sent: 25-Jun-2018 05:02
From: Richard Vincins
Subject: Response to 483

Yes, thank you for this information especially what you had included Ginger - very interesting.  I had worked with a couple local districts that maybe were still "old school" wanting paper or maybe they were just saying that was the official response and I was hearing them say that as please send in paper copies haha.

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

Original Message:
Sent: 20-Jun-2018 10:10
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

Thank you for taking the time to share all of that great information. Your inputs and advice have been extremely helpful.
Original Message:
Sent: 20-Jun-2018 08:24
From: Ginger Glaser
Subject: Response to 483

With the recent ORA reorganization, FDA is now saying (in a few recent trade press articles and presentations) you should send 483 responses in both email and paper copy. The email address for devices is

Division 1: oradevices1firmresponse@fda.hhs.gov
Division 2: oradevices2firmresponse@fda.hhs.gov
Division 3: oradevices3firmresponse@fda.hhs.gov

The paper copy, oddly, should go to the Division Director in your old District office w/ Attn: Compliance on the letter. The electronic copy is now consider the "official" response. In fact FDA says they would prefer you not send paper copies but they realize that isn't going to happen :-)

I'd suggest you reach out to the Division Program Director and ask how they would prefer to receive a response that is too big for email - after first trying like crazy to actually get the response compressed down to be able to be sent via email. Be prepared to suggest a lot of possibilities, including sending it to them on a CD etc.

Ginger

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

Original Message:
Sent: 20-Jun-2018 04:31
From: Richard Vincins
Subject: Response to 483

What Christine recommended is the best approach; send in a hard copy with tracking to confirm receipt.

Regarding electronic submission; as far as I know for FDA Form 483 responses from a completed inspection FDA does not accept electronic submission.  In fact, the response to Form 483 should be done to local FDA district office (D.C. for foreign inspections) and they may not have capability to record information in an electronic system like eCopy for 510(k) submissions.

In my experience, FDA does not accept documents through FTP or any other file-sharing system because the government system needs to be protected from viruses, intrusions, etc.  I tried to share a large file with an FDA reviewer a while back and I ended having to send in a Supplement with the file on a CD/DVD.

Now this does not mean you could have a conversation with the local FDA district office to inquire if they will accept an electronic version of the Form 483 response through email or some other medium.  Nowadays, they may do this but it would be dependent upon the district office I think and what capability they have to accept electronic only responses.

Worse comes to worse if you have an electronic version with hyperlinks and bookmarks, send in a hard copy + CD/DVD with the electronic version.  In the cover letter to the Form 483 response explain that the CD/DVD has an electronic version that is navigable with hyperlinks and bookmarks.

I would be curious if the wider RAPS group has ever submitted electronic Form 483 responses that have been accepted.

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

Original Message:
Sent: 19-Jun-2018 11:22
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

What in case if response(50+mb) has hyperlinks and bookmarks and it is recommended to send electronically instead of normal mail.

Does FDA accepts documents through FTP?
Original Message:
Sent: 19-Jun-2018 10:49
From: Christine Anderson
Subject: Response to 483

​I have always seen written responses that were sent via FedEx. You want to have traceability that you responded. It doesn't hurt to also follow up to confirm that FDA received your response.

Regards

------------------------------
Christine Anderson
Senior Principal Specialist
Regulatory & Quality Solutions

Original Message:
Sent: 19-Jun-2018 10:11
From: Anonymous Member
Subject: Response to 483

This message was posted by a user wishing to remain anonymous

Does anyone know what is the best way to send response to FDA 483?
-Mail
-Email
-Fax
-ESG

what in case if file exceeds the size to be sent through email? (i.e.) more than 50 mb

Thank you for your help.