Regulatory Open Forum

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  • 1.  Early Intervention FDA BIMO Inspections

    Posted 20-Jul-2017 15:05
    Dear Colleagues,

    I have been hearing through the grapevine that FDA has been doing "early intervention" BIMO inspections, prior to submission of a PMA.  My BIMO experience is all with inspections post-PMA submission.

    Can anyone fill in any details about this initiative?  Specifically, does anyone have insight into what triggers an early intervention inspection?

    Thank you.

    Julie Broderick RAC
    Broderick Regulatory Consulting, LLC
    Winchester MA
    United States

  • 2.  RE: Early Intervention FDA BIMO Inspections

    Posted 21-Jul-2017 08:21
    This has been an initiative of FDA for several years now. At my last organization we had these circa 2013 on the study that ultimately supported our last PMA. Keep in mind that FDA is aware of the study via your IDE, and they probably have a very good idea if the product ultimately will go PMA. If I had to guess, they used IDE annual reports as triggers, because they started by going to several of our early enrolling sites.

    In many ways, this is a good thing, because if there are issues at the sites, FDA makes the site aware of them before it becomes a critical path item for your PMA! In our case, they did not do an "early" sponsor inspection. However, I have heard of a couple of companies that supposedly have. I suspect they make that decision based on what they find vis-a-vis sponsor controls at the sites.

    Despite the timing, they really are traditional BIMO inspections and you would prepare the same way - just make sure to prepare your sites early and well!


    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States

  • 3.  RE: Early Intervention FDA BIMO Inspections

    Posted 21-Jul-2017 11:35
    ​This was an initiative that actually started many years ago at FDA, with the objective to help sponsors make mid-course corrections to investigator activities and data quality while the study is still underway, rather than waiting for all the mistakes to accumulate either due to inadequate monitoring or other reasons. By waiting for the marketing application as the BIMO kick-off point, sponsors and FDA may not detect risky behavior until it is too late, subjects could be placed at greater and unnecessary risk, and data could be unusable (i.e., rejected) that was intended by the sponsor to support the application. We did a study at 6 sites for an implantable device and had BIMO inspectors show up at 4 of them within 6 months of study start (it was a 12-month follow-up trial). One of the sites had only enrolled a couple cases at that point, while another site had enrolled many but had serious problems that occurred during surgery in a manner hidden to routine monitoring. That latter site eventually got a Warning Letter and their data was unusable by the sponsor (root cause, no surprise: not following the investigational plan).

    Anyway, I think sponsors should be glad FDA has the bandwidth to get BIMO inspectors out before trials are over. At least you have to opportunity to improve the trial quality and repair potential site/data disasters your own monitors miss. But of course you cannot and should not depend on FDA to be your back-up quality department!  You should also expect that this is a risk-based priority system for FDA BIMO, as has always been the case, so higher risk products (e.g., an implantable device in my example) would be far more like to have a BIMO inspection during the trial than a study determined to be IDE-exempt (a nonsignificant risk or NSR study). There is probably a wide middle ground for these risk determinations, so it will depend a lot on your device and its risk profile, the size of the trial, novelty of the product, and other factors.

    Jan S. Peterson, MS, RAC
    Senior Regulatory Affairs Manager
    The Emmes Corp
    Rockville MD
    United States