Enforcement Discretion

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  • Matching Mole

    Senior Member
    England, English
    It would be useful to provide more context and background in the post, rather than referring us to a link, which may not be permanently available.
    Enforcement Discretion when:
    • Investigation meets the IDE exemption criteria at 21 CFR 812.2 (c)(3)
    • The study uses leftover specimens
    [further bullet points]
    Earlier in the presentation it states:
    FDA intends to exercise enforcement discretion, under certain circumstances
    This is a Powerpoint presentation and the language is abbreviated. "Enforcement Discretion when:" in short for "Enforcement discretion [will be exercised] [in the following circumstances]:"

    Officers have the discretion to enforce regulations. That means it is up to them to decide when the regulations apply and whether to enforce them. A list of typical circumstances follows.
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