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  • 1.  US FDA Classification of Dry powder inhaler

    Posted 03-Jul-2023 06:40

    Hi Everyone,

    Can anyone help me with the class into which the Dry Powder Inhaler falls as per US FDA classification of Medical Devices. Do we have to file a 510(k) for this?



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    Anoosha Bhat
    Bengaluru
    India
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  • 2.  RE: US FDA Classification of Dry powder inhaler

    Posted 03-Jul-2023 10:53

    Hi Anoosha

    Dry powder inhalers are unclassified, with device product code QKS:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=239

    Were you planning to offer it as a standalone device? Usually they are evaluated as part of a combination product. Here is a draft guidance that shows some of the expectations: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/metered-dose-inhaler-mdi-and-dry-powder-inhaler-dpi-drug-products-quality-considerations



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: US FDA Classification of Dry powder inhaler

    Posted 04-Jul-2023 04:11

    Hello Anoosha,

    As Anne said these are Unclassified and have generally been submitted in the United States as part of the new drug application.  There are companies which make these devices typically independent of the pharmaceutical manufacturer, but they usually are submitted with the drug application.  Note: there are no independent devices which have been cleared under the Product Code Anne showed.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: US FDA Classification of Dry powder inhaler

    Posted 04-Jul-2023 12:32

    Dear Anoosha,

    Anne is correct that these devices are unclassified with product code QKS.  However, it is important to note that the classification is entitled "Inhaler, Metered Dose Or Dry Powder, Cder Or Cber Led", indicating that the agency does not believe that this would be subject to a device clearance or approval.

    Also, as indicated by Anne, the expectations for quality and performance are related to the inhaler's use with the specific drug product, usually in an NDA, ANDA or BLA, as detailed in the guidance to which she referred.



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    Lee Leichter RAC
    President
    Fort Denaud FL
    United States
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    Original Message


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