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510(k) RTA Checklist

  • 1.  510(k) RTA Checklist

    Posted 03-Jan-2020 08:25

    Hi All. 

    I hope you all had a good Christmas and a Happy New Year. 

    I was wondering whether people generally complete the RTA checklist manually or use a tool to edit the pdf before including in a 510(k) submission?

    Thanks

    James



    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------


  • 2.  RE: 510(k) RTA Checklist

    Posted 03-Jan-2020 09:28
    Hi James,

    I completed the checklist manually for a recent submission. 

    Thanks,
    Meenakshi

    ------------------------------
    Meenakshi Verma
    Regulatory Affairs Professional - Medical Devices
    Ontario
    Canada
    ------------------------------

    Original Message


  • 3.  RE: 510(k) RTA Checklist

    Posted 03-Jan-2020 10:42
    Thanks Meenakshi. 

    I know both options would be fine, just wondering what the consensus was.

    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------

    Original Message


  • 4.  RE: 510(k) RTA Checklist

    Posted 03-Jan-2020 15:31
    Edited by Michael Hottner 03-Jan-2020 15:32
    Hi James & Meenakshi,

    I did it manually as well in the past.
    But I recently learned in a training that the agency also provides RTA checklists in MS word format upon request.
    It would be awesome if anybody in the forum already got such a version from the FDA and would share the empty template here!?

    Michael

    ------------------------------
    Michael Hottner
    Köln
    Germany
    ------------------------------

    Original Message


  • 5.  RE: 510(k) RTA Checklist

    Posted 03-Jan-2020 17:01
    Hi James,

    I think editing the pdf will save time in the long run, although creating all of the fields for text and check-boxes may be time consuming. You could look for an editable version online, but this way you would know that it is the most up-to-date checklist that you're working with.

    ------------------------------
    Keegan Bate
    Regulatory Affairs Associate
    Salt Lake City UT
    United States
    ------------------------------

    Original Message


  • 6.  RE: 510(k) RTA Checklist

    Posted 04-Jan-2020 06:25
    We always complete the RTA Checklist as part of the final review of the 510(k) submission, usually by a second person to "challenge" any section or information that would be raised during the Administrative Review by the FDA.  We do not include the RTA submission in the checklist because while a FDA Reviewer can see you do it by your company, they still go through the process independent of your checklist content.  Therefore, we do not submit it - but definitely we use it as our final check.

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

    Original Message


  • 7.  RE: 510(k) RTA Checklist

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jan-2020 08:51
    This message was posted by a user wishing to remain anonymous

    While the reviewer must complete their own version independently, I always include a completed RTA checklist in the submission as it directs the reviewer to the content. I think it makes the task easier for the reviewer, which is my ultimate goal! In fact, I used to annotate the checklist with page numbers and then FDA added a column for page numbers.
    Original Message


  • 8.  RE: 510(k) RTA Checklist

    Posted 04-Jan-2020 08:11
    I just did one, using my own previous Word version checklist so I could insert it in the submission and manipulate it easier.

    But I have professional verson of Adobe and used the edit tools to revise my old RTA checklist with copy paste functions from this year's new checklist.

    Wouldn't it be great if FDA made their checklists more easily available?


    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 9.  RE: 510(k) RTA Checklist

    This message was posted by a user wishing to remain anonymous
    Posted 06-Jan-2020 09:22
    This message was posted by a user wishing to remain anonymous

    I converted it to Word by saving the PDF on my hard drive and opening the PDF in Word. Then from the Forms or Developer tools in Word, I inserted the first check box and deleted what was I  the document. I copied that box to the clipboard and pasted throughout, thus creating a fillable form that I could use. Also had to fix fonts in some of the black spaces. Saved as a Word document. Submitted and passed RTA check with no problems. And then FDA updated the RTA.....Good to know FDA will provide a Word version. I can tell from the meta data on FDA CDRH guidance that they create the PDF by just saving them from Word to  PDF (instead of the more robust way of letting Acrobat create the PDF), so it is good they can provide that Word document.
    Original Message


  • 10.  RE: 510(k) RTA Checklist

    Posted 04-Jan-2020 13:45
      |   view attached
    James,

    Attached is a pdf version that you can convert using the professional version of Adobe or convert using pdf converted in Word.

    Regards,
    Bob

    ------------------------------
    Robert Wilkinson
    President
    Port Barrington IL
    United States
    ------------------------------

    Attachment(s)

    pdf
    001_RTA-Checklist-for-Traditional-510k.pdf   697 KB 1 version
    Original Message


  • 11.  RE: 510(k) RTA Checklist

    Posted 06-Jan-2020 02:46
    Thanks for all the replies, a nice little mixture.

    Having the checklists in a format where they can be edited would be very welcome. Saying that, I have noticed some of the forms can be edited, not too sure why they all cannot. 

    Interesting that you do not include a checklist in the submission Richard. Although the reviewer will use their own checklist, hopefully this would serve as something extra in case they are going to reject for something they cannot find. Any extra help that you can give can only be beneficial!

    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------

    Original Message


  • 12.  RE: 510(k) RTA Checklist

    Posted 07-Jan-2020 10:47
    Hi James,

    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!

    ------------------------------
    Pamela Martin RAC, BSc, MSc
    Regulatory Affairs Project Manager
    Jacksonville FL
    United States
    ------------------------------

    Original Message


  • 13.  RE: 510(k) RTA Checklist

    Posted 07-Jan-2020 11:01
    Hi all,

    As a brief corrective statement: I double checked my training notes and realized that I wrote down 'fillable pdf version' instead of MS word document.

    @Pamela: Thanks for sharing the documents! 

    Best wishes,
    Michael

    ------------------------------
    Michael Hottner
    Köln
    Germany
    ------------------------------

    Original Message


  • 14.  RE: 510(k) RTA Checklist

    This message was posted by a user wishing to remain anonymous
    Posted 08-Jan-2020 08:51
    This message was posted by a user wishing to remain anonymous

    Thanks for sharing! I had one of these a while back from when the reviewer wasn't able to convert it to the static version to send to me. I miss having the active version. For non-sterile and non-electrical devices it saves so much paper to omit (compact) those sections.
    Original Message


  • 15.  RE: 510(k) RTA Checklist

    Posted 07-Jan-2020 10:58
    Using the "Fill & Sign" feature in Adobe Acrobat Pro DC has been quite helpful for us in completing RTA checklists. I do wish the pdf were set up as a form to begin with, but you've got to work with what you've got. Good luck!

    ------------------------------
    Michael Thomas
    Regulatory Affairs Manager
    Salt Lake City UT
    United States
    ------------------------------

    Original Message


  • 16.  RE: 510(k) RTA Checklist

    Posted 07-Jan-2020 12:49

    "you've got to work with what you've got"

    As does CDRH.  It is useful to remember that the RTA is a tool developed for reviewers, not for industry.  CDRH does not require its inclusion in the submission, so really no reason it should invest its resources to develop it in fillable format, unless it wants to do so for its own purposes.



    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 17.  RE: 510(k) RTA Checklist

    Posted 07-Jan-2020 11:06
    I think it could be helpful for the reviewer to know whether you are in agreement regarding what is included and, especially, what is N/A..  I know if I were a reviewer, I'd note any points of disagreement and then go back and take a closer look, in case I missed or misunderstood something.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 18.  RE: 510(k) RTA Checklist

    Posted 07-Jan-2020 13:08
    To answer the comment about not providing the RTA checklist in the actual 510(k) submission  I talked to a couple reviewers (it was only 2 people, others might yse it) they both said never looked at the RTA checklist the company filled out.  Because they had to fill it out their own and did not want to be "influenced" by what maybe was on an already filled out RTA checklist by the company.

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

    Original Message


  • 19.  RE: 510(k) RTA Checklist

    Posted 07-Jan-2020 16:43
    Yep. If I were a reviewer, I would not look at the company's checklist until I'd done mine first. But then my inquiring mind would want to know.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 20.  RE: 510(k) RTA Checklist

    Posted 08-Jan-2020 15:03
    So now I'm wondering if we might all be missing the point.  I ask the question the other way...why wouldn't you include the completed checklist?  I can't think of any reason not to, if you have completed it.  I can't imagine not completing it, but perhaps others see it differently?

    Does anyone not find the checklist helpful in its own right, so that, if you didn't think it would be useful to include in the submission, you wouldn't bother to complete it?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 21.  RE: 510(k) RTA Checklist

    Posted 08-Jan-2020 15:43
    Julie

    I always include to remind myself of triggers - like when they change references in there, it triggers me to go look  (e.g. reprocessing FR notice in 2017 was a change).  

    And their own guidance recommends you include it, regardless of if the RTA folks use it or not. 

    Ginger

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 22.  RE: 510(k) RTA Checklist

    Posted 09-Jan-2020 03:29
    I am with you Julie, I cannot really see a reason as to why you would not want to include. If 99 reviewers never looked at it, there could be a time where that one reviewer cannot see the evidence and this is when they might find it useful. When you are looking at a stack of information it is not always easy to see the wood for the trees! If there is any way to mitigate any delays with a submission, I am all for it.

    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------

    Original Message


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