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  • 1.  Custom Device update

    Posted 13-Jul-2012 13:10

    The FDA Safety and Innovation Act was signed into law this week and includes amended rules regarding custom devices.

    http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/default.htm

    http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf
    (custom devices are discussed in Section 617 [pdf page 70])

    To those of you who deal with orthopaedic implants, and have been following the recent enforcement saga between FDA and J&J/DePuy over custom devices, I would like to ask for your thoughts regarding this particular aspect of the new law.

    thanks
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    Vineet Sarin PhD
    Camarillo CA
    United States
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  • 2.  RE:Custom Device update

    Posted 13-Jul-2012 14:42
    in response to "To those of you who deal with orthopaedic implants, and have been following the recent enforcement saga between FDA and J&J/DePuy over custom devices, I would like to ask for your thoughts regarding this particular aspect of the new law.":

    Under the relevant sections, general provisions sound "wild."

    But under limitations, it is highly restricted as follows.

    "...for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical..."

    "...limited to no more than 5 units per year of a particular device type..."
     
    "...the manufacturer of such device notifies the Secretary on an annual basis..."

    However, there may be some leeway (a hole) for an abusive practice.  For example, the number "five (5)" might/could/would be interpreted as "5,000" if not 50,000 or more.   

    Compliance is the key to success!  

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    www.RegulatoryDoctor.com
    United States
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    Original Message


  • 3.  RE:Custom Device update

    Posted 17-Jul-2012 10:43
    I suggest you never interpret "5" as anything more than 5...

    The big question is, is the device the same unit -- counted as among the "5" -- when you customize each one?

    FDA still distinguishes between a device that is truly custom and a device that is modified or "customized."  Here are two good resources:

    http://www.lexology.com/library/detail.aspx?g=4907b1d5-8f2d-4b74-bc5a-6efe438bea7c

    http://www.hoganlovells.com/files/Publication/82e3fe87-c212-4176-9b95-a0c9e66d8dcc/Presentation/PublicationAttachment/d80493e4-a620-4ecc-a933-aa227d9d9d09/JMDRAug2011_Woodlee.pdf

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    Andrea Chamblee RAC, FRAPS
    Director
    FDA
    Rockville MD
    United States
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    Original Message