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  • 1.  FDA Definition of "Enforcement Discretion"

    This message was posted by a user wishing to remain anonymous
    Posted 02-Mar-2018 08:45
    This message was posted by a user wishing to remain anonymous

    Hi All,

    With the push for all the new guidances due to new Acts and Initiatives, there are numerous instances where guidances mention the FDA's stance on certain devices to be in the scope of "enforcement discretion".  Can someone please explain in black and white what this means?  Say it's for something that's a Class I device.  Would this mean that although the general requirements for a QMS and device listing still stand for Class I devices, that the FDA will not be checking this for that particular device?  How would this affect Class I MFR's that only produce product that fall under enforcement discretion?  Would they be subject to the FDA audit schedule?


  • 2.  RE: FDA Definition of "Enforcement Discretion"

    Posted 02-Mar-2018 09:57
    ​When FDA states its intention to use enforcement discretion, it is stated with respect to a particular requirement or regulation.  It means that FDA intends not to enforce the particular provisions of the stated requirement/regulation. My understanding is that the concept is born from general law enforcement (i.e., not just FDA law enforcement).

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