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Definition of Point of Use for Corrections and Removals - 21CFR806

Discussion in 'US Medical Device Regulations' started by Qualityforum Mainar, Feb 6, 2017.

  1. Qualityforum Mainar

    Qualityforum Mainar New Member

    Feb 6, 2017
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    Part 806 mentions removals and corrections in regards to "point of use". Can anyone direct me to government/FDA source information about the definition of "point of use"? Would point of use be restricted to a doctor's office where the actual device is being used? Is a Correction and Removal report required if a product located at a customer's/distributor's warehouse needed to be relabeled?
  2. Vintage Goose

    Vintage Goose Active Member

    Oct 6, 2015
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    Hi, unfortunately, I cant find it written anywhere, but I have always taken the recall and corrections definitions to mean products that have been manufactured, released, and distributed to customers (users) in the field, ie at their "point of use. Basically as soon as the product has left your control. So relabelling product at a customer's warehouse is still a Correction.
  3. yodon

    yodon Well-Known Member

    Aug 3, 2015
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    I agree with Vintage Goose. If you take a more contextual look, it seems (to me) a bit clearer. There are 2 places where "point of use" is stated:
    • (d) Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.
    • (j) Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.
    In both cases, they're talking about taking it from one location to another. To me, like Vintage Goose points out, would have to include all released product (left your control) to ensure the actions are complete (and you want to be able to assert completeness in the report!)