Regulatory Open Forum

 View Only

  • 1.  LTF included with Special 510(k)?

    This message was posted by a user wishing to remain anonymous
    Posted 23-Apr-2021 08:38
    This message was posted by a user wishing to remain anonymous

    Should I include previous letters to file (LTF) in the attachments to a Special 510(k)?


  • 2.  RE: LTF included with Special 510(k)?

    Posted 25-Apr-2021 10:09
    Hello Anon,

    Simple answer: no.  A Special 510(k) would stand on its own as a regulatory submission.  However, what should be included or considered if your original 510(k) information differs from what you are submitting in the 510(k) submission.  The idea with a Special 510(k) is there are minor changes which would require a submission, but would not be significant enough for a Traditional 510(k) - refer to the guidance documents.  I have seen a couple times where the cumulative changes of the device made over time, i.e. all the letter to files added up, resulted in the device being "questioned" during the Special 510(k) as compared to the original 510(k) and had the company switch to a Traditional 510(k).

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    Emergo Group Inc
    ------------------------------

    Original Message


  • 3.  RE: LTF included with Special 510(k)?

    Posted 26-Apr-2021 10:20
    We don't include the actual LTFs, but we do include a summary table of all of them that have happened since the last 510(k), including a brief description and brief rationale why no filing was required. . Not required, but we had a strategic reason to do so, and it has been useful.

    Ginger

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

    Original Message


  • 4.  RE: LTF included with Special 510(k)?

    This message was posted by a user wishing to remain anonymous
    Posted 26-Apr-2021 17:10
    This message was posted by a user wishing to remain anonymous

    Very helpful, thanks Richard and Ginger.
    Original Message


  • 5.  RE: LTF included with Special 510(k)?

    Posted 27-Apr-2021 09:18

    We also include a brief summary of the LTF changes (not the actual LTF's) to ensure that FDA has a current understanding of the full device. Furthermore, we find it helps a lot of global registrations where they want to see language specifically in a 510(k) as the country of origin.  It is imperative in any submission type (Traditional or Special) that LTF's are well written and sound in rationale. The last thing you want is to hold up what you thought was a simple change, to Richard's point, due to some LTF changes. An area where this can really pose an issue is with cumulative change. Too many small changes, can be enough to tip scales away from  a "Documentation only" assessment. 

    Kind Regards,



    ------------------------------
    Isabel McGann, MS, RAC
    Regulatory Program Manager
    United States
    ------------------------------

    Original Message


Related Content