Regulatory Open Forum

 View Only

  • 1.  Contract Manufacturer FDA Registration

    Posted 01-Oct-2014 19:24
    We are not a manufacturer of a finished Medical Device, but supply critical subassemblies to the finished device manufacturer.  If we add services to re-design and distribute a finished Medical Device to the end user, are we required to register? Or there additional circumstances involved?  

    -------------------------------------------
    Frederick Cole
    Hayward CA
    United States
    -------------------------------------------


  • 2.  RE: Contract Manufacturer FDA Registration

    Posted 02-Oct-2014 07:02
    Frederick,

    Without knowing the details it is hard to give 100 % reliable advice.

    However, if you re-design the device, this potentially puts you in the position of being a specification developer with the requirement not only to register, but to maintain the design history file.

    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.3

    http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070627.htm

    If you distribute a device manufactured in the US, thre is no requirement by FDA for you to register per se. However, if you are distributing on behalf of a non-US manufacturer and are the first entity to take title of the units when they enter the US, then you must register as an initial importer.


    Here is the source for who must register and list
    http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm

    -------------------------------------------
    Jean Bigoney PHD
    Managing Member
    Nu Device Consulting LLC
    Newport NH
    United States



  • 3.  RE: Contract Manufacturer FDA Registration

    Posted 02-Oct-2014 11:34
    Hi, Frederick,

    Servicing finished medical devices requires ostensibly the same regulatory oversight as does manufacturing finished medical devices, as your firm is asserting that a device that comes into your facility that may not meet its stated specifications, will meet its stated/approved specifications when it leaves your facility.  You may not have to defend design control if you are not designing the device.  This is another issue you should discuss internally.

    Regards,

    Barry

    -------------------------------------------
    Barry Craner RAC
    Vice President, QA/RA
    Stellartech Research Corp.
    Milpitas CA
    United States
    -------------------------------------------


    Original Message