Chief Compliance and Ethics Officer Health Care

LIS vs LIMS and FDA regulation

  • 1.  LIS vs LIMS and FDA regulation

    Posted 07-22-2020 12:56 PM
    Folks,
    I am sure I read something in the last year that indicated the LIS and LIMS were not regulated by FDA as medical devices.  I've been asked to look into this and can't find the resources I thought I read.  Can anyone definitively answer whether or not a laboratory information system or a laboratory information management system is subject to FDA registration/regulation as medical devices?  If you can also provide a source, I would greatly appreciate it!  I can't seem to find any conclusive statement that indicates it is or it isn't.

    Thanks very much!

    ------------------------------
    Jana Rasmussen
    Compliance Manager
    LUMEA, Inc
    Lehi,UT
    ------------------------------
    19th Annual CEI Virtual Conference


  • 2.  RE: LIS vs LIMS and FDA regulation

    Posted 15 days ago
    Hello Jana,
    I was wondering the same thing and found a recent FDA guidance which states (I'm paraphrasing) that if the software functions to analyze or interpret data it is subject to regulatory requirements for medical devices.  Here's the link:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices

    Hope that helps!

    ------------------------------
    Cheryl Conard
    Madison,WI
    ------------------------------

    19th Annual CEI Virtual Conference