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  • 1.  FDA Enforcement Discretion - Submission Type

    Posted 01-Feb-2019 12:36
    Hello -

    As I am researching product classifications and product codes I have come across a few items that have a submission type of 'Enforcement Discretion'. What exactly does "enforcement discretion' mean? 

    Thank you.

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    Meghan Moore
    Regulatory Affairs Specialist
    Andover MN
    United States
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  • 2.  RE: FDA Enforcement Discretion - Submission Type

    Posted 01-Feb-2019 17:17
    It means FDA does not routinely enforce this requirement, but reserves the right to do so, at its discretion.​  Like the rest of us, FDA does not have the resources to do everything it is "spozed" to do, and it takes a risk-based approach to resource allocation.  Where it sees low risk, it tends to avoid allocating resources, and direct them instead to where it sees higher risk. 

    I think of a lot of these things as similar to the traffic rules (e.g. "you must signal 100 feet in advance of a turn") that are never enforced...unless you get into an accident and it appears that failure to follow one of these rules was a contributing factor.

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


  • 3.  RE: FDA Enforcement Discretion - Submission Type

    Posted 05-Feb-2019 12:08
    We had one of these products that we were manufacturing and to make it even more vague its device classification (typically I, II, III) was "Not Classified."  If you research many of the phone apps you will see enforcement discretion or "not classified" in your reviews.  When I did this research I contacted the agency and asked... their response was to ask me why I was asking... what a shock, but the net result was the product was not a significant concern in their eyes.

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    Rick Muller RAC
    Technical Director
    Aurora CO
    United States
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    Original Message


  • 4.  RE: FDA Enforcement Discretion - Submission Type

    Posted 05-Feb-2019 14:33
    Hi Meghan.

    I look at the term as FDA doing exactly what the term says - the FDA is choosing not to enforce an otherwise legally enforceable requirement.  So in the case of devices, it could be that the FDA is looking and saying there is so little a risk in this device causing harm to a consumer in the present landscape that attempting to enforce this registration/listing/notification requirement on the marketplace would cause us to use significant amounts of already tight resources that it is truly something that the cost does not even break even on the "benefit".  However, the key is to remember and understand that this is essentially a risk decision based on current state.  If things in the area change or if companies start getting over-the-top with claims or uses or anything else that FDA might be able to take issue with and were to determine that these changes now require an update to the discretion calculus, the FDA has every right to essentially start enforcement of the issue immediately and truly does not legally (so far as I understand it) have to do anything except to start enforcing this.  While FDA has often put out notices that it "intends to exercise enforcement discretion" on a particular topic, I don't think FDA is required to do this and therefore I also don't believe that FDA is required to put out a notice that says that they are rescinding that decision.

    Let's just be realistic for a minute - FDA could never (with current or even foreseeable future) resources handle every single issue that could potentially arise.  So they, like industry, have to choose where to place their limited resources for the most effective, efficient and pragmatic use of the limited resources available.  So by stating they are exercising discretion, they are essentially stating that they are not choosing to spend agency resources (time, personnel, money, etc.) on handling something that they do not see a current problem.​

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


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