Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The Refuse to Accept Policy for 510(k)s FDA guidance document issued on Sept 2019 includes acceptance checklist in Appendix A for traditional 510(k) but that cannot be filled in. Where can I find a checklist which can be easily filled in?

Thanks in advance!

This message was posted by a user wishing to remain anonymous

Folks here have said that they have e-mailed the FDA to get a Word version. Or you can open it in Word and convert it to be filled in, but it will take some time. I did this with older versions.
Original Message:
Sent: 05-May-2020 00:38
From: Anonymous Member
Subject: Traditional 510(k) RTA checklist

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The Refuse to Accept Policy for 510(k)s FDA guidance document issued on Sept 2019 includes acceptance checklist in Appendix A for traditional 510(k) but that cannot be filled in. Where can I find a checklist which can be easily filled in?

Thanks in advance!

Yes, I think there were some previous posts where people uploaded Word versions you can get; just need to look around a little.

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

Original Message:
Sent: 05-May-2020 13:06
From: Anonymous Member
Subject: Traditional 510(k) RTA checklist

This message was posted by a user wishing to remain anonymous

Folks here have said that they have e-mailed the FDA to get a Word version. Or you can open it in Word and convert it to be filled in, but it will take some time. I did this with older versions.
Original Message:
Sent: 05-May-2020 00:38
From: Anonymous Member
Subject: Traditional 510(k) RTA checklist

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The Refuse to Accept Policy for 510(k)s FDA guidance document issued on Sept 2019 includes acceptance checklist in Appendix A for traditional 510(k) but that cannot be filled in. Where can I find a checklist which can be easily filled in?

Thanks in advance!

This message was posted by a user wishing to remain anonymous

Why not use Adobe to fill out the form?  You will need it to compile the submission anyway.
Original Message:
Sent: 05-May-2020 00:38
From: Anonymous Member
Subject: Traditional 510(k) RTA checklist

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The Refuse to Accept Policy for 510(k)s FDA guidance document issued on Sept 2019 includes acceptance checklist in Appendix A for traditional 510(k) but that cannot be filled in. Where can I find a checklist which can be easily filled in?

Thanks in advance!

This message was posted by a user wishing to remain anonymous

When this was first issued we printed it out, filled in the answers with careful handwriting and then scanned it back in - which seemed to be perfectly acceptable. Since then we've converted their form to a fillable PDF.​
Original Message:
Sent: 05-May-2020 00:38
From: Anonymous Member
Subject: Traditional 510(k) RTA checklist

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The Refuse to Accept Policy for 510(k)s FDA guidance document issued on Sept 2019 includes acceptance checklist in Appendix A for traditional 510(k) but that cannot be filled in. Where can I find a checklist which can be easily filled in?

Thanks in advance!

I used Foxit Reader to fill the PDF. I think it uses some other mechanism to fill but the end result looks the same.

------------------------------
Umar Waqas
Nijmegen
Netherlands
------------------------------

Original Message:
Sent: 05-May-2020 00:38
From: Anonymous Member
Subject: Traditional 510(k) RTA checklist

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The Refuse to Accept Policy for 510(k)s FDA guidance document issued on Sept 2019 includes acceptance checklist in Appendix A for traditional 510(k) but that cannot be filled in. Where can I find a checklist which can be easily filled in?

Thanks in advance!

This message was posted by a user wishing to remain anonymous

For an older version of the RTA, I saved the PDF file as a Word document. Then I went through and for each checkbox, I deleted and then replaced it with a Word checkbox. I also fixed some of the borders. It took a little time. Then tada, I had a nice form that could be filled out. Unfortunately, FDA updated the RTA a few months later and I had already submitted my 510(k) so didn't recreate it.
Original Message:
Sent: 05-May-2020 00:38
From: Anonymous Member
Subject: Traditional 510(k) RTA checklist

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The Refuse to Accept Policy for 510(k)s FDA guidance document issued on Sept 2019 includes acceptance checklist in Appendix A for traditional 510(k) but that cannot be filled in. Where can I find a checklist which can be easily filled in?

Thanks in advance!

Hey Anon,

I started emailing the 510(k) staff a few years ago requesting the fillable versions that the reviewers use (with javascript code, etc) because of the manual issue with the static version of the .pdfs. In my experience, the 510(k) staff process the request expeditiously, usually within a few days.

I've attached the current version of the 510(k) checklists. :)

Cheers!

------------------------------
Pam Martin, RAC, MSc
Regulatory Affairs Project Manager
KLS-Martin L.P.
Jacksonville, FL
USA
------------------------------

Original Message:
Sent: 05-May-2020 00:38
From: Anonymous Member
Subject: Traditional 510(k) RTA checklist

This message was posted by a user wishing to remain anonymous

Hi RAPS members,

The Refuse to Accept Policy for 510(k)s FDA guidance document issued on Sept 2019 includes acceptance checklist in Appendix A for traditional 510(k) but that cannot be filled in. Where can I find a checklist which can be easily filled in?

Thanks in advance!