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  • 1.  combination products

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jun-2018 11:33
    This message was posted by a user wishing to remain anonymous

    ​

    Is a drug solution in a plastic bag for Intravenous infusion (for example a 500 L plastic IV bag of antibiotic solution) considered a drug-device combination product? Or just a drug, since you would also need an IV set and tubing to administer the product?



  • 2.  RE: combination products

    Posted 13-Jun-2018 07:32
    The IV solution by itself is a drug. It would only be considered a combination product if it were packaged with a delivery device (e.g., an infusion set) or if it contained a delivery device already attached/connected/integral to the bag as one system. There is another type of combination product where cross-labeling occurs between the drug and device, but this is not common for drugs contained in IV bags in my experience. 

    Regards,
    Nathan

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    Nathan Blazei
    Director, Quality & Compliance
    Durham NC
    United States
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    Original Message


  • 3.  RE: combination products

    Posted 13-Jun-2018 07:46
    The IV bag (or vial), when sold empty, is considered a medical device.  So, if you read the definition, one could conclude that when sold filled with drug these would be considered combination products. 

    I have discussed this with FDA and thankfully, at this point in time, FDA (Office of Combination Products) has not declared that products that store drugs (primary packaging such as vials and solution bags) are to be considered combination products.  Their threshold, as provided in rule and guidance, is that the Primary Packaging would need to provide a "delivery function" in order to be considered a Device constituent Part and the product a Combination Product.

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    Lee Leichter RAC
    President
    Fort Myers FL
    United States
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    Original Message


  • 4.  RE: combination products

    Posted 13-Jun-2018 11:21
    Hello,

    Lee is correct from an FDA perspective that 'at this time' that the storage bags are still considered medical devices as themselves.  From a European perspective, there is a clear rule in the MDR that devices used to store or administer medical devices have classifications.  Now whether they are considered a combination products or precisely a borderline product depends on the Primary Mode of Action (PMOA) of the actual device.  Just like the FDA, IV bags and administration sets are considered medical devices by them selves and depending on what drug is being delivered may be Class IIa or IIb or something else.  Other countries around the world generally are also classified similar to the FDA.

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    Richard Vincins RAC
    Vice President Regulatory Affairs
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    Original Message


  • 5.  RE: combination products

    This message was posted by a user wishing to remain anonymous
    Posted 14-Jun-2018 11:50
    This message was posted by a user wishing to remain anonymous

    ​Thank you Lee,
    Can you please point in the direction of the rule and guidance you are referring to?
    Thanks,
    Cindy
    Original Message


  • 6.  RE: combination products

    Posted 14-Jun-2018 18:59
    I agree with everyone and again a great place to learn about what jurisdiction this type of product is under based on how it is made/packaged/used.   

    The below FDA website - Section V III talks about the general criteria that will apply in making device/drug determinations:

    https://www.fda.gov/CombinationProducts/JurisdictionalInformation/ucm121177.htm

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    Lin Wu, RAC
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    Original Message


  • 7.  RE: combination products

    Posted 15-Jun-2018 15:01
    ​The regulation is 21 CFR Part 4, Combination Product GMPs.  It is addressed in Comment 8 of the preamble.  The guidance is the Final Combination Product GMP Guidance.  It is addressed in section IV.C.3.

    I hope that helps.


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    Lee Leichter RAC
    President
    Fort Myers FL
    United States
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    Original Message


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