Regulatory Open Forum

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  • 1.  FDA 510(k) pre-clearance inspection?

    Posted 30-May-2017 20:20
    This query was posted to a LinkedIn Group, but I think this group is more likely to have an answer...

    Has anyone experienced an FDA 510(k) pre-clearance inspection? If yes, how long after the 510(k) submission was the inspection performed? Is the firm domestic or foreign? Did they review the DHF of the product under 510(k) review to ensure compliance with design controls? Or, did they perform a general QSIT level II inspection?

    I am asking because the Infusion Pumps Total Product Life Cycle Guidance for Industry and FDA Staff (Draft) Document issued on December 2, 2014, states that 510(k) pre-clearance inspection could be considered.

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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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  • 2.  RE: FDA 510(k) pre-clearance inspection?

    Posted 30-May-2017 20:39
    Hi Julie,
    I also had this question posed to me via LinkedIn. I have not seen a facility inspection be initiated during a 510(k); however, I have seen facility inspections, initiated for a class III product hold up approvals of class II approvals due to process related 483s or facility related 483s. While the infusion pump guidance mentions that an inspection could happen, I'm not sure how the Office of Compliance would know to initiate the inspection. Class III PMA submissions automatically ping the Compliance office; however, class II devices do not. To my knowledge, the compliance office would not know about a 510k submission until after clearance and subsequent product listing.

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    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
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  • 3.  RE: FDA 510(k) pre-clearance inspection?

    Posted 31-May-2017 22:56
    Thanks, Michael.   Yeah, my reaction was that it sounded like more of a statement about how seriously FDA takes infusion pumps than anything to do with the likelihood of an inspection.  "Threat" is too strong a word, but closer to that than a reality, I was thinking.

    Did you respond on LinkedIn?  I've discovered that it was posted to several Groups, but not with much success.

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



  • 4.  RE: FDA 510(k) pre-clearance inspection?

    Posted 01-Jun-2017 19:47
    No I was sent the question directly from a friend. I'm not sure if he was the original poster on LinkedIn or wanted my advice to answer the question there. I don't frequent the public forums on LinkedIn much.

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    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
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