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  • 1.  Label Requirements for Demo Device

    This message was posted by a user wishing to remain anonymous
    Posted 04-Aug-2022 15:14
    This message was posted by a user wishing to remain anonymous

    We are developing a single-use drug-device combination product that is regulated as a drug.  The device is small with limited space on its label.  Our sales team would like to have a demonstration device filled with placebo that they can demo in an HCP's office.  What are the minimal information requirements for the drug label?  Can you point me to a regulation or guidance that outlines the requirements?


  • 2.  RE: Label Requirements for Demo Device

    Posted 05-Aug-2022 12:28
    Dear Anon,

    The two critical requirements are that it be clearly different from the actual product to prevent confusion and accidental misuse and the second if to be identified "Not for Human Use.

    I would also make sure that every effort is made for this demo to be done by, and the used demo product be disposed of or taken with, the sales rep.

    I do not have any refences.

    Lee

    ------------------------------
    Lee Leichter RAC
    President
    Fort Denaud FL
    United States
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    Original Message


  • 3.  RE: Label Requirements for Demo Device

    This message was posted by a user wishing to remain anonymous
    Posted 08-Aug-2022 14:35
    This message was posted by a user wishing to remain anonymous

    Hi Anon,

    I am unsure if the drug or your device is the primary mode of action in your combo but I have written this as the drug is the primary mode of action and takes Regulatory precedence (although you still need to ensure require with any device constituent requirements).

    I would recommend using the Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors | FDA guidance for drug requirements.  Within here there is a section covering product samples (Section V.J) with minimum requirements. 

    To paraphrase you need to include for a placebo in accordance with drug requirements:
    * Status as a drug sample (e.g., sample, not for sale, professional courtesy package (21 CFR 203.38(c))).
    * Small container guidance: Proprietary (if any) and established names; dosage form; lot number or control number; and name of the manufacturer, packer, or distributor of the drug (§ 201.10(i))
    * Expiration date
    * Product strength  (generally I put 'Contains no active substance/drug' if a placebo)

    As mentioned its a drug-device combo product you will also need to consider any device labelling requirements that are associated and impact if its a device with a medical clearance vs integral device constituent regulated as drug with primary mode of action (if integral device constituent need to include for 'use with TRADENAME only').

    Hope this helps!
    Original Message


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