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  • 1.  Packaging an FDA Class I Exempt with a Class II 510k Device

    This message was posted by a user wishing to remain anonymous
    Posted 21-Feb-2019 08:33
    This message was posted by a user wishing to remain anonymous

    Is there a regulatory issue with packaging an FDA Class I Exempt device with an existing, cleared Class II device?

    Thanks.


  • 2.  RE: Packaging an FDA Class I Exempt with a Class II 510k Device

    Posted 22-Feb-2019 06:22
    Not to my knowledge, but from a cGMP/QSR perspective there could be other implications that need to be considered like sterilisation, cleanliness, individual packages, modifying packaging, etc.  There may also be considerations if a prescription device is being packaged with a non-prescription device, but this also depends on how it is being packaged and sold.  The question is fairly general, so a general answer, but there could be other implications based on the device types.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Packaging an FDA Class I Exempt with a Class II 510k Device

    Posted 22-Feb-2019 07:00
    Did you consider if this situation meets the definition of a convenience kit? There has been guidance out for some time and the term is recognized in the CFR. Example: "(11) A device packaged within the immediate container of a combination product or convenience kit, provided that the label of the combination product or convenience kit bears a UDI."

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    Timothy Kline, Ph.D., RAC
    Senior Associate Regulatory Affairs
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    Original Message


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