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  • 1.  CFR Sec. 801.122 Medical devices for processing, repacking, or manufacturing

    Posted 03-Mar-2016 06:19

    Dear all,

    reading the CFR section specified in the subject of this email, it suggests that a device intended for use in the manufacture of another device could itself be classified as a medical device. However, the definition of medical device as stated in US regulation (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm) does not seem to include devices which are intended for use in the manufacture of another device.

    Where is the misunderstanding, please?

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    Lorenzo Muratori
    Elekta
    West Sussex
    United Kingdom
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  • 2.  RE: CFR Sec. 801.122 Medical devices for processing, repacking, or manufacturing

    Posted 03-Mar-2016 10:07
    Lorenzo,

    You seem to have eagle eyes, pointing out the issue. 

    BT: the FDA link you used is broken.  I suppose you wanted to share this FDA link.

    What you read is the statutory definition under FDCA 201(h) (downloadable in PDF here). 

    You were reading the labeling requirements/provisions under 21 CFR 801.122, which reads as shown below (as of March 1, 2016; access to the latest version through here):

    §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".

    Please be noted that the FDA regulations implement the applicable statute(s) or statutory requirements (e.g., FDCA), the regulations reflect what/how the FDA implements the said statute. 

    The FDA would have to clarify on the issue at some point in my opinion!

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



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    Original Message


  • 3.  RE: CFR Sec. 801.122 Medical devices for processing, repacking, or manufacturing

    Posted 04-Mar-2016 09:52

    Be careful here that you don’t chase your own tail. The CFR section refers to devices, i.e., something that is already a device. It then says that if the device has an appropriate statement on the label (Caution: For manufacturing, processing, or repacking) it is exempt from §502(f)(1) of the FD&CA. This section is codified as 21 USC §352 Misbranded drugs and devices and §352(f)(1) says that a device is misbranded unless the labeling has adequate directions for use.

    Consequently, a device manufacturer who ships a device for any of these three purpose does not have include the directions for use with the device.

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    Dan O'Leary
    Swanzey NH
    United States

    Original Message