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  • 1.  Requirements for Auto-injector

    This message was posted by a user wishing to remain anonymous
    Posted 31-Oct-2018 09:56
    This message was posted by a user wishing to remain anonymous

    Good morning colleagues, 
    My company is looking into developing an auto injector for a product currently administered by an HCP. We currently market similar products,  and are considering  working with some other companies to develop and test the device. As all my experience is in the drug world, I was hoping that you could point me in the right direction as to where I could find the appropriate regulations for an auto injector. I know it is considered a class 2 device, and I have the guidance "Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products"  but I would appreciate any additional help you can provide. 
    Thank you!


  • 2.  RE: Requirements for Auto-injector

    Posted 01-Nov-2018 05:50

    Good morning

    Some autoinjectors are regulated as devices (class 2; general use injectors) but in some cases they are regulated as combination products. Which pathway is acceptable to the FDA depends on several factors. We assisted many Clients regarding both pathways in the past and I'm happy to assist you. Please send an email to beat.steffen@confinis.com. 

    Cheers, Beat



    ------------------------------
    Beat U. Steffen
    Founder & CEO
    confinis ag
    Düdingen
    Switzerland
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    Original Message


  • 3.  RE: Requirements for Auto-injector

    Posted 01-Nov-2018 07:32
    Auto-injectors may or may not be considered combination products and there is probably not enough space in the forum to go into all the details regarding these type of products.  However, it should be noted you made reference to the guidance document, strongly recommend you read it, follow it, and absorb it, because FDA scrutinises auto-injector devices heavily.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: Requirements for Auto-injector

    Posted 01-Nov-2018 15:53
    Hi anonymous,
    You are correct, the guidance document is the best place to start when learning about the regulatory requirements for auto injectors.  It is important to note that the classification, the regulatory filing, etc. are all dependent on the final product configuration.   If it would be of use to you, my company is in the business of developing, testing, and manufacturing auto injectors.  If you'd like to reach out to us directly for possible assistance contact us  at   inquiries@antarespharma.com.  Good luck!  
    Sara

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    Sara Coon
    Associate Director, Regulatory Affairs
    MN United States
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    Original Message


  • 5.  RE: Requirements for Auto-injector

    Posted 03-Nov-2018 08:02
    ​Dear Anon,

    If you are looking for guide in the development of an autoinjector (AI), the appropriate technical guidance is provided in the ISO 11608 series of standards.  This would be the starting point for generating data to support a CE Mark in the EU and to support a submission in the USA.

    For a reusable AI that is designed, and can be shown, to deliver more than one currently marketed drug in the USA, where the labeling of that drug would not be needed to be modified, the device would be class 2 and accepted as a premarket notification submission (a 510(k)). If the reusable AI is for an investigational drug, or if the drug label would need to be modified, then the drug and device would be considered a combination product.


    If the drug is integrated (sold already assembled with the drug), the "device classification" loses meaning as this product is a regulated as a medicinal product in the EU and is a combination product regulated as a drug in the USA.

    I hope that helps you get started.  If there is one at your company with experience in the area, I suggest you seek help.

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    Lee Leichter RAC, MBA
    President
    P/L Biomedical
    Fort Myers FL
    United States
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    Original Message


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