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  • 1.  FDA Establishment Registration

    This message was posted by a user wishing to remain anonymous
    Posted 10-Nov-2020 08:48
    This message was posted by a user wishing to remain anonymous

    Hello! 

    I was hoping someone could help as I have not been able to find a clear answer on the FDA's website. The company I work for manufactures class II medical devices. Our current manufacturing facility (registered with the FDA) has exceeded manufacturing capacity. In order to meet production demands, a new facility was built in the same city. Does the second manufacturing location also need to be registered using the FDA's FURLS website?


  • 2.  RE: FDA Establishment Registration

    Posted 10-Nov-2020 10:06
    Try 21 CFR 807:
    Sec. 807.20 Who must register and submit a device list?

    (a) An owner or operator of an establishment ... who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and submit listing information for those devices in commercial distribution, except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments... An owner or operator of an establishment located in any State as defined in section 201(a)(1) of the Federal Food, Drug, and Cosmetic Act shall register its name, places of business, and all establishments and list the devices whether or not the output of the establishments or any particular device so listed enters interstate commerce. The registration and listing requirements shall pertain to any person who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use...
    ​
    And also
    Sec. 807.3 Definitions.

    (c) Establishment means a place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed.

    I would imagine if you've put up another building on the same campus it would be considered the same general physical location. If it's far away, and an inspector visiting one site would have no idea of the existence of the other, it would probably be considered a separate establishment with the same owner/operator.

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    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: FDA Establishment Registration

    Posted 16-Nov-2020 10:27
    What Anne said is exactly what out local office told us when we asked a couple years ago.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 4.  RE: FDA Establishment Registration

    Posted 10-Nov-2020 10:08
    I looked for my reference and I cannot find it quickly- however, in general yes, it needs its own registration number - unless it is built as part of a "campus" or co-located next to each other/etc.

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    Jackie Torfin
    President/Principal Consultant
    Maple Grove MN
    United States
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    Original Message


  • 5.  RE: FDA Establishment Registration

    Posted 10-Nov-2020 17:53

    I agree with Anne and Jackie.  When promulgating 21 CFR Part 807, FDA received a similar question from public stakeholders.   Specifically, the public comment suggested that only one establishment of a company be required to register for each device, thereby allowing the manufacturer to determine which location would be the most appropriate one to register.  FDA rejected the suggestion.  FDA stated that if a device is processed wholly or in part at more than one establishment, then, for inspectional purposes, FDA needs to be aware of all establishments at which the subject device is manufactured, prepared, propagated, compounded, or processed.  FDA concluded therefore that all such establishments must be registered.

    Hope this helps,



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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    ComplianceAcuity, Inc.
    Ridgway, CO
    United States
    www.complianceacuity.com
    © Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


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