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  • 1.  Class I Devices - NOT 510(k) Exempt?

    Posted 30-Jul-2020 00:15
    I am in search of Class I devices that are NOT exempt from premarket notification. 

    If anyone knows of a neat little list, I'd appreciate it if you pointed me to it.  If anyone knows of an easy way to find them in an FDA database, the same.  If you happen to know of a non-exempt Class I, I'd be happy to hear about it, too.

    Thanks,

    ------------------------------
    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
    ------------------------------


  • 2.  RE: Class I Devices - NOT 510(k) Exempt?

    Posted 30-Jul-2020 02:17
    You can go to the product classification database and select  "510k" under the submission type and select Class I as the drop down for the Class.

    ------------------------------
    Isabella Schmitt, RAC
    Regulatory Affairs Consultant
    Houston TX
    United States
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    Original Message


  • 3.  RE: Class I Devices - NOT 510(k) Exempt?

    Posted 30-Jul-2020 02:50
    Edited by Kevin Randall 30-Jul-2020 02:51
    To see neat little lists of Class I 510(k)-exempt (and/or GMP-exempt) devices grouped by classification panel, click on each panel at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm

    Hope this helps.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden, CO
    United States
    www.complianceacuity.com
    Note that I'm now far older and even uglier than in the photo above. Brace yourselves for my updated photo coming soon.
    © Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 4.  RE: Class I Devices - NOT 510(k) Exempt?

    Posted 30-Jul-2020 02:52
    Edited by Kevin Randall 30-Jul-2020 03:00
    Clarifying my post made on this late evening after a long day: The lists only show which ones are 510(k) and/or GMP-exempt, so the classification database method noted by Isabella Schmitt is a great way.

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden, CO
    United States
    www.complianceacuity.com

    ------------------------------

    Original Message


  • 5.  RE: Class I Devices - NOT 510(k) Exempt?

    Posted 30-Jul-2020 09:01
    I think you are referring to the reserved devices. See first paragraph under Class I Devices header here https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/315.cfm

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    Adam Atherton
    Farragut TN
    United States
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    Original Message


  • 6.  RE: Class I Devices - NOT 510(k) Exempt?

    Posted 30-Jul-2020 11:57
    Thanks Isabella, Kevin, Adam.  Very relieved to know I don't have to search for them one by one!

    ------------------------------
    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


  • 7.  RE: Class I Devices - NOT 510(k) Exempt?

    Posted 31-Jul-2020 09:45
      |   view attached
    Julie,
    Attached is a list of all Class I product codes with their submission type and GMP exemption status.  Included all Class 1 codes, so you can sort as you like.  Need another piece of info on these?  Let me know and I will run another report.
    Cheers,
    Melissa

    ------------------------------
    Melissa Walker RAC
    President & CTO
    St Louis MO
    United States
    ------------------------------

    Attachment(s)

    xlsx
    Class 1 product codes 2020-07-27.xlsx   135 KB 1 version
    Original Message


  • 8.  RE: Class I Devices - NOT 510(k) Exempt?

    Posted 31-Jul-2020 11:50
    Thanks, Melissa.  I was actually looking for not 510(k) exempt, rather than not GMP exempt.  I think Isabella has got me pointed in the right direction, but if I run into problems, or have follow-on questions, I'll be back...

    ------------------------------
    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


  • 9.  RE: Class I Devices - NOT 510(k) Exempt?

    Posted 31-Jul-2020 12:25
    You can see that in the "Submission Type" column.  Just sort based on that column and they should pop right up.

    Cheers,
    Melissa

    ------------------------------
    Melissa Walker RAC
    President & CTO
    St Louis MO
    United States
    ------------------------------

    Original Message


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