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  • 1.  Nebulizer Regulatory Documentation for Phase 1 Studies

    Posted 25-Apr-2023 11:07

    Hi RAPSers,

    Without getting too 'in the weeds', is there a core list of testing that needs to be performed for an uncleared nebulizer device to support its use in a Phase 1 study to deliver a drug? From the research I have done, the key regulatory documents for nebulizers appear to be ISO 13485, 14971, and 27427. I am aware of the US and EU guidances on orally inhaled drugs as well, although they do not specify a Phase-appropriate approach as much as an overall licensure approach.

    I'm new to the device world and attempting to define what a good Phase 1 data package looks like for a nebulizer device, to screen from a selection of a candidate devices.

    Thanks for your help!

    Marshall



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    Marshall Hoke
    Director of Regulatory Affairs
    Lafayette CO
    United States
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  • 2.  RE: Nebulizer Regulatory Documentation for Phase 1 Studies

    Posted 27-Apr-2023 04:22

    Hi Marshall,

    I can share what is required for the UK and I believe other countries have similar list of required documents.
    Device details

    Essential requirements checklist / General Safety and Performance Requirements checklist
    Risk analysis
    Instructions for use of a medical device
    Device labels
    Summary of all bench testing and pre-clinical testing conducted
    Summary of all clinical experience with the device to date
    End of study reports for any concluded clinical investigations that involved the same medical device under investigation
    List of standards met
    Sterilisation validation report (where relevant)
    Software information (where relevant)
    Biological safety assessments of patient contacting materials (where relevant)
    Information on animal tissues (where relevant)
    Information on any medicine or human blood derivative, or non-viable human tissues and cells incorporated into the device 

    Have a good day.
    Olga



    ------------------------------
    Olga Peycheva
    Regulatory and Study Start Up Specialist
    Solutions OP Ltd
    olga.peycheva@solutionsop.co.uk
    United Kingdom
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    Original Message


  • 3.  RE: Nebulizer Regulatory Documentation for Phase 1 Studies

    Posted 27-Apr-2023 09:03
    Edited by Rajeswari Devanathan 27-Apr-2023 09:23

    Hi Marshall,
     For phase 1 studies main requirement is mainly to make sure the device is developed and manufactured even phase 1 device batch in a quality-controlled environment - ISO 13485.
    All the risk measures are mitigated as per ISO14971.
    Essential requirement /performance of the device is tested along with ISO 27427:2013 specifies requirements for the safety and performance testing of general purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.
    ISO 10993: This is a series of standards that provide guidance on the biocompatibility of medical devices. It covers various aspects of biocompatibility, including cytotoxicity, sensitization, and irritation.
    other important aspect is labelling requirement and detailed information on manufacturing process. 
    if applicable ISO 20072: This standard provides guidance on the validation of medical devices that are intended to be sterilized by moist heat. 



     




    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


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