Regulatory Open Forum

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  • 1.  Labeling for Repair Components & Sub-assemblies

    Posted 22-Oct-2014 08:15

    We are the manufacturing site for a medical device in the USA. I am being asked to ship components and sub-assemblies to another state in the USA and also to Germany to support service/repair centers within my company (not a 3rd-party) that will repair the devices and return them to the user. I'm trying to understand the labeling requirements for these components and sub-assemblies that are shipping intra-company.

    I'm aware of 21 CFR Part 801.122 that states:  Subpart D--Exemptions From Adequate Directions for Use Sec. 801.122 Medical devices for processing, repacking, or manufacturing. A device intended for processing, repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the act if its label bears the statement "Caution: For manufacturing, processing, or repacking".  

    However, I'm not sure that this applies as I am shipping components and sub-assemblies, not fully (or almost) functional medical devices.  It's not clear to me if I need to apply any additional or special labeling at all.

    I'm curious how other device manufacturers are handling this.  What are your thoughts?
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    John L. Haney
    Director, Quality Assurance & Compliance
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  • 2.  RE: Labeling for Repair Components & Sub-assemblies

    Posted 23-Oct-2014 22:12
    Hi John,

    I would propose that since you are shipping components and sub-assemblies, which I assume have quality control attributes for acceptance and use, to support service/repair centers within you company, that the quality control attributes of the component and sub-assemblies are more critical than the actual labeling for shipment other than a component or subassembly.  I would propose that these components and sub-assemblies have been identified in your repair process and are no different than your release of the components for the final device and have been evaluated in your repair procedures. I would propose that you don't need additional or special labeling as these are components and subassemblies as long as they have specification to support their use? 

    These are my thoughts but I look forward to the expertise in the open forum,

    Best regards,

    Dar

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    Darlene Rosario RAC
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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    Original Message


  • 3.  RE: Labeling for Repair Components & Sub-assemblies

    Posted 25-Oct-2014 09:58

    The distinction between components and a finished device is very important. You can read the definitions in 820.3. Assuming the parts you are shipping are in fact, components, then none of the FDA rules for devices apply. The fact that the product is a component for a medical device is not relevant. There may be other rules for the type of product.

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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message