Hi Ginger.
I am personally in favor of anything that makes the global regulatory environment easier to navigate especially where so much of the work is so similar and there are limited "additions" or "variations on the theme" between jurisdictions.
My point was that FDA retraining field staff in ISO but not publishing the fact that they are using ISO or can use ISO or whatever is just as impractical as field staff continuing to audit solely against QSR when FDA is willing to accept ISO. The bigger issue that I have is that FDA "allowing" for ISO but not mandating it will ultimately end up in insane when it comes to inspections (at least in the near term) because inspectors almost invariably will fall back on what they "know" as opposed to what the regulation might say.
Finally, the idea that FDA would "accept" ISO without publishing what they will "accept" really doesn't, in my opinion, qualify as meeting the "notice" requirement in "notice-and-comment" rulemaking. How can someone who doesn't have access to the document being discussed possibly provide any reasoned comment without knowing what they are commenting on? So if you think about it, it could be argued that FDA violates Administrative Procedures Act requirements if they don't publish the entire text of the document when you ask stakeholders to comment on it.
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 11-May-2018 08:00
From: Ginger Cantor
Subject: FDA Supplanting QSR with ISO 13485
Hello Victor,
They would just accept it as their recognized consensus standard? No need to republish, but they may need the rule making and public comment, as they stated. And for gosh sakes retrain the field operations!
I was talking about this last night with a client currently in audit preparation for ISO 13485, and I am glad they are hooked up with a reputable Notified Body. They did this, even though FDA was going to be their first market, and for that they would also have to meet QSR. BUT their other markets all required ISO 13485.
The client rightly pointed out that in this time of a shortage of Notified Bodies or companies available to certify the QMS to ISO 13485, this could have a huge impact on small US companies or those companies who only market in the US and only ever planned to stay in the US. Now they have to assess and/or remediate to ISO. Will there be enough resources?
Maybe it won't be a big deal, but it will be interesting to follow.
Thoughts?
Ginger Cantor, MBA, RAC
(+1) 715-307-1850
Original Message------
Hi Lena.
This is rather interesting to me for the simple reason that FDA is essentially claiming it will harmonize with ISO but technically aren't ISO documents copyright protected? So really the only way that this can happen (I think) is for FDA to publish essentially the entire ISO document as a Federal Register notification in the form of notice-and-comment rulemaking. That is a potential copyright issue (unless FDA has gotten permission from ISO????) but the bigger issue I see is the updating process. As you likely realize the ISO documents can be reviewed and updated every few years so is FDA planning to update and keep the QSR requirements equivalent to ISO because I would think that would be a significant potential drain on resources at the agency....
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Victor Mencarelli
Director Regulatory Affairs
United States
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