Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi Everyone - 

In the wake of our current global situation, my company is working from home, however in a few weeks will be submitting a new 510(k). Is anyone aware of FDA's current situation on allowing companies to submit applications electronically, such as through a portal, like they do MDRs versus mailing an eCopy with a hard copy signed Cover Letter?

Any feedback would be greatly appreciated! Stay safe out there!

Hi there - I have similar concerns in relation to an upcoming 510(k) submission. Based on FDAs March 23rd Letter to Industry it looks like the DCC will continue to process incoming documents. They cannot accept email and they are looking into electronic options but they are not there yet. For now, mailing the eCopy with Cover Letter seems to be the route. 

https://www.fda.gov/media/136383/download?utm_campaign=2020-03-24%20CDRH%20Issues%20Letter%20to%20Industry%20on%20COVID-19&utm_medium=email&utm_source=Eloqua



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Kenny Walsh
Galway
Ireland
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Original Message:
Sent: 31-Mar-2020 11:30
From: Anonymous Member
Subject: Submitting eCopy Electronically vs. By Mail

This message was posted by a user wishing to remain anonymous

Hi Everyone -

In the wake of our current global situation, my company is working from home, however in a few weeks will be submitting a new 510(k). Is anyone aware of FDA's current situation on allowing companies to submit applications electronically, such as through a portal, like they do MDRs versus mailing an eCopy with a hard copy signed Cover Letter?

Any feedback would be greatly appreciated! Stay safe out there!

The FDA has a pilot program for e-Submissions through a portal as such, but this is limited to certain device types at the moment.  And I think even by invitation for the company to participate in the program.  They will not accept a submission via email.  There is a process through DCC for review, assignment, uploading to their internal service, etc., so sending through email would not work.  You could probably contact FDA directly to see if could participate in the e-Submission process.  But for now, it would still be sending the eCopy on a USB stick/CD/DVD through postal mail.

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

Original Message:
Sent: 01-Apr-2020 03:51
From: Kenny Walsh
Subject: Submitting eCopy Electronically vs. By Mail

Hi there - I have similar concerns in relation to an upcoming 510(k) submission. Based on FDAs March 23rd Letter to Industry it looks like the DCC will continue to process incoming documents. They cannot accept email and they are looking into electronic options but they are not there yet. For now, mailing the eCopy with Cover Letter seems to be the route.

https://www.fda.gov/media/136383/download?utm_campaign=2020-03-24%20CDRH%20Issues%20Letter%20to%20Industry%20on%20COVID-19&utm_medium=email&utm_source=Eloqua

------------------------------
Kenny Walsh
Galway
Ireland

Original Message:
Sent: 31-Mar-2020 11:30
From: Anonymous Member
Subject: Submitting eCopy Electronically vs. By Mail

This message was posted by a user wishing to remain anonymous

Hi Everyone -

In the wake of our current global situation, my company is working from home, however in a few weeks will be submitting a new 510(k). Is anyone aware of FDA's current situation on allowing companies to submit applications electronically, such as through a portal, like they do MDRs versus mailing an eCopy with a hard copy signed Cover Letter?

Any feedback would be greatly appreciated! Stay safe out there!

Thank you both, Kenny and Richard! We received the March 23rd letter as well, just hoping there was some expedited actions happening that I was not aware of. Thanks again! Stay safe.

------------------------------
Katie Rutland
Senior Regulatory Affairs Specialist
Jacksonville FL
United States
------------------------------

Original Message:
Sent: 01-Apr-2020 04:49
From: Richard Vincins
Subject: Submitting eCopy Electronically vs. By Mail

The FDA has a pilot program for e-Submissions through a portal as such, but this is limited to certain device types at the moment.  And I think even by invitation for the company to participate in the program.  They will not accept a submission via email.  There is a process through DCC for review, assignment, uploading to their internal service, etc., so sending through email would not work.  You could probably contact FDA directly to see if could participate in the e-Submission process.  But for now, it would still be sending the eCopy on a USB stick/CD/DVD through postal mail.

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

Original Message:
Sent: 01-Apr-2020 03:51
From: Kenny Walsh
Subject: Submitting eCopy Electronically vs. By Mail

Hi there - I have similar concerns in relation to an upcoming 510(k) submission. Based on FDAs March 23rd Letter to Industry it looks like the DCC will continue to process incoming documents. They cannot accept email and they are looking into electronic options but they are not there yet. For now, mailing the eCopy with Cover Letter seems to be the route.

https://www.fda.gov/media/136383/download?utm_campaign=2020-03-24%20CDRH%20Issues%20Letter%20to%20Industry%20on%20COVID-19&utm_medium=email&utm_source=Eloqua

------------------------------
Kenny Walsh
Galway
Ireland

Original Message:
Sent: 31-Mar-2020 11:30
From: Anonymous Member
Subject: Submitting eCopy Electronically vs. By Mail

This message was posted by a user wishing to remain anonymous

Hi Everyone -

In the wake of our current global situation, my company is working from home, however in a few weeks will be submitting a new 510(k). Is anyone aware of FDA's current situation on allowing companies to submit applications electronically, such as through a portal, like they do MDRs versus mailing an eCopy with a hard copy signed Cover Letter?

Any feedback would be greatly appreciated! Stay safe out there!

The documents they issued last week said they do not have the capability through an electronic portal and thus hard copies still need to be mailed through the document control center to have a submission officially logged.

It could be your reviewer(s) would let you email them, but no official timing would start in that case.

g-

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

Original Message:
Sent: 31-Mar-2020 11:30
From: Anonymous Member
Subject: Submitting eCopy Electronically vs. By Mail

This message was posted by a user wishing to remain anonymous

Hi Everyone -

In the wake of our current global situation, my company is working from home, however in a few weeks will be submitting a new 510(k). Is anyone aware of FDA's current situation on allowing companies to submit applications electronically, such as through a portal, like they do MDRs versus mailing an eCopy with a hard copy signed Cover Letter?

Any feedback would be greatly appreciated! Stay safe out there!

This message was posted by a user wishing to remain anonymous

Keep in mind you are not sending the entire 510(k) by hard copy; only the cover letter and a USB stick. So even if you are working from home, you should be able to put that into an envelope, affix a few stamps, and send it on.
Original Message:
Sent: 31-Mar-2020 11:30
From: Anonymous Member
Subject: Submitting eCopy Electronically vs. By Mail

This message was posted by a user wishing to remain anonymous

Hi Everyone -

In the wake of our current global situation, my company is working from home, however in a few weeks will be submitting a new 510(k). Is anyone aware of FDA's current situation on allowing companies to submit applications electronically, such as through a portal, like they do MDRs versus mailing an eCopy with a hard copy signed Cover Letter?

Any feedback would be greatly appreciated! Stay safe out there!

Have you installed the eSubmitter that's mainly used for 510(k) eSubmission for OIVD? In Feb this year CDRH announced its voluntary eSTAR Pilot Program that builds on the eSubmitter platform to improve efficiency in both industry's preparation and FDA's review of traditional 510(k) submissions. FDA is currently accepting requests for participation and will select up to nine participants who meet the selection criteria.
Refer here for details: 
https://www.fda.gov/medical-devices/premarket-notification-510k/510k-program-pilots

------------------------------
Jo Huang RAC
Assoc Manager - Regulatory Affairs
Irvine CA
United States
------------------------------

Original Message:
Sent: 01-Apr-2020 08:34
From: Anonymous Member
Subject: Submitting eCopy Electronically vs. By Mail

This message was posted by a user wishing to remain anonymous

Keep in mind you are not sending the entire 510(k) by hard copy; only the cover letter and a USB stick. So even if you are working from home, you should be able to put that into an envelope, affix a few stamps, and send it on.
Original Message:
Sent: 31-Mar-2020 11:30
From: Anonymous Member
Subject: Submitting eCopy Electronically vs. By Mail

This message was posted by a user wishing to remain anonymous

Hi Everyone -

In the wake of our current global situation, my company is working from home, however in a few weeks will be submitting a new 510(k). Is anyone aware of FDA's current situation on allowing companies to submit applications electronically, such as through a portal, like they do MDRs versus mailing an eCopy with a hard copy signed Cover Letter?

Any feedback would be greatly appreciated! Stay safe out there!