Regulatory Open Forum

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  • 1.  Off-the-shelf Surgical instruments

    Posted 27-Aug-2015 10:52

    Does anyone have experience with Off-the-shelf instruments purchased for surgical sets sent to hospitals, regarding the type of supplier controls and information required of the supplier? We are trying to differentiate them from Class II implant-specific instruments as we don't own the design, but of course want to ensure the quality of the instruments being provided. Right now, we have requested an ISO 13485 or 9001 certs they have and a short form that describes the type of quality system they have in place. Just curious what others have done or if anyone has experience with this.

    Thanks!!

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    Carrie Long
    Columbia City IN
    United States
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  • 2.  RE: Off-the-shelf Surgical instruments

    Posted 28-Aug-2015 08:33

    Carrie,

    Many surgical instruments are Class I devices.  Although they would be exempt from 510(k) pre-market notification, they are not exempt from compliance with 21 CFR 820 and FDA Device Listing and Establishment Registration requirements.  Also, as of September 24, 2018 all Class I devices distributed in the U.S. will require compliance to UDI.

     

    Carol Ryerson

    Sr. Principal Advisor, RCRI

     




    Original Message


  • 3.  RE: Off-the-shelf Surgical instruments

    Posted 12-Sep-2015 12:01

    This is a gray area, are the instruments Class I or Class II?  In many cases, instruments are Class I.  

    • If they are Class II the manufacturer must have a valid 510K.  

    • "All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA."  (See FDA's Guidance Class I / II Exemptions)
    • Should have ISO 13485 

    • Sterilization and IFU are an important consideration to verify 

    Keep in mind the above as you proceed.  If you are a distributor all you need are the bulleted items, if you repackage the instruments, you have additional responsibilities including but not limited to registration.

    Important: Do not make any claims outside the original Intended Use and properly identify the manufacturer.  

    A note: An implanted device is not be referred to as an implanted instrument.  Instruments are used to implant medical devices.

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    Russell Pizzuto
    President
    PPRE Consulting LLC
    Solon, Ohio 44139
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    Original Message