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  • 1.  Implant specific instruments FDA

    This message was posted by a user wishing to remain anonymous
    Posted 29-Sep-2017 09:17
    This message was posted by a user wishing to remain anonymous

    Dear All,

    what is the definition and policy of FDA regarding implant or device specific instruments? I am not aware of any guidance regarding this topic. Is this the same like the accessories?

    I am looking especially for any experience in conjuction with spine implants.

    Any feedback on that topic is highly appreciated!

    Thank you!

    Kind regards,


  • 2.  RE: Implant specific instruments FDA

    Posted 29-Sep-2017 12:57
    ​I just went through an FDA inspection in June with one of my spinal implant clients.

    The inspection was triggered as part of FDA's risk-based manual orthopedic surgical instrument device assignment deployed in late 2016. We pressed FDA to share with us more details about the risk-based assignment, but FDA was quite secretive and wouldn't reveal any more details other than the fact that the assignment existed.  In fact, the only reason we discovered the inspection to be a risk-based assignment at all is because we pressed FDA (as I do in any FDA inspection) to tell us the basic reason for the inspection.  Had we not asked, it seems that FDA would not have disclosed the risk-based assignment.

    To establish implant-specific links between the instruments and implants, FDA focused relentlessly on the instrument labeling and promotional materials, as well as the instrument engineering features.

    One of FDA's big concerns is the complexity of today's instruments and their ability to be properly cleaned/reprocessed.  Many modern orthopedic surgical instruments have quite sophisticated designs.  Consequently, firms that make reusable orthopedic instruments should be ready for FDA scrutiny regarding cleaning validation.

    FDA also focused carefully on any complaints received related to the instruments.

    Overall during the inspection, FDA was more concerned about the instruments than the implants themselves. This can get tricky because orthopedic implant companies often categorize their manual orthopedic surgical instruments as class I devices under FDA classification regulation 21 CFR 888.4540.  Proper instrument design and development controls, including but not limited to cleaning requirements, is a key to avoiding significant 483 Observations, Warning Letter citations, etc.

    Hope this helps,

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------



  • 3.  RE: Implant specific instruments FDA

    Posted 29-Sep-2017 13:17
    Hi Keven,

    FYI: Orthopedic surgical instrument devices seem to be those under high alert due to high volumes of complaints received by the FDA.

    I had a chance to review 43 different orthopedic device types at FDA based on risk profiles. 

    Since FDA inspection policy has been changed, it should be expected that FDA inspectors can show up and knock on their door anytime.  

    I can identify potential safety issues in no time!

    Thank you.

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

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.







  • 4.  RE: Implant specific instruments FDA

    Posted 29-Sep-2017 13:26
    Hi Kevin,

    FDA focused relentlessly on the instrument labeling and promotional materials, as well as the instrument engineering features.

    This may have been triggered by whistleblowers' complaints filed under the False Claims Act (FCA). Based on your description, it fits the profile of such.

    Thank you.

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

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.







  • 5.  RE: Implant specific instruments FDA

    Posted 29-Sep-2017 14:29

    Under FADARA, all device inspections are now on a risk-based schedule, not calendar time. I wondered how this might have affected your client's inspection or your probing for the inspection's reason.

    The risk factors are (in my summary):

    • Participation in international device audit programs
    • Compliance history of the establishment
    • Recalls linked to the establishment
    • The inherent risk of the device
    • Inspection frequency and history
    • Foreign government or agency inspection
    • Any other necessary and appropriate criteria


    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
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  • 6.  RE: Implant specific instruments FDA

    Posted 29-Sep-2017 15:26
    ​Thank you Dan!  My inspection didn't appear to be a routine part of FDA's overall FADARA risk-based inspection planning. For example, before discussing the risk-based assignment with us, the investigator needed to get special permission first, which took FDA a couple days to decide.  It doesn't seem like such antics would have been associated with a basic FADARA risk-based inspection.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------



  • 7.  RE: Implant specific instruments FDA

    Posted 29-Sep-2017 13:39
    ​Thanks for those insights David!

    Cheers,
    Kevin

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------



  • 8.  RE: Implant specific instruments FDA

    Posted 27-Apr-2018 17:31

    Interesting update:

    Though there are no significant GMP violations, FDA has escalated my aforementioned directed inspection of manual orthopedic surgical instruments to now involve follow-up auditing by CDRH (Office of Device Evaluation).  It appears FDA will be scrutinizing / demanding design control compliance, and I also expect an assertion for premarket notification even though the devices are orthopedic surgical instruments viewed by the firm as design-control-exempt, 510(k)-exempt class I devices under FDA classification regulation 21 CFR 888.4540.

    Another interesting fact: FDA instructed us not to bring any lawyers to the meeting.  This seems to indicate to me that they know they are pressing an envelope with the corresponding statutory/regulatory requirements.  I will however acknowledge that we questioned FDA's statutory and regulatory intent when FDA began going "off book" (i.e., not following QSIT) during the initial inspection.

    Clearly I get it that FDA has the ultimate statutory authority and probably the enforcement creativity to act (no pun intended) and increase the required regulatory controls in order to appropriately assure public health, such as by leveraging the limitations of the ".9" clause of the classification regulations.

    I'm curious to learn more about other orthopedic surgical instrument companies' related experiences (if any there are).  I wonder if FDA is using my small-company client to more easily start setting an industry precedent rather than wrangling with a larger orthopedic company whose regulatory / legal resources are more robust.

    It will be interesting to see how this unfolds.



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    ------------------------------