Ha! Don't tease me, Seymour! If ever there were fertile ground for "teasing out," it's the MDR. For me, who got into regulatory for the intellectual challenge, it's a marvelous gift, the second perfect "bookend" for a medical device regulatory career. (The Temple Report, which I have cited elsewhere, sits at the other end of the shelf.)
The truth is there is no perfect analogy here...two different frameworks, two different government systems, but many useful points of comparison. Think the fact that both the third parties and notified bodies are for-profit enterprises is far from a trivial similarity. Before user fees, this characteristic would have sharply distinguished them from FDA, but today, not so much. (Last year, I ran into someone inside the bubble who referred to CDRH as "the diploma mill.")
On the flip, the CAs get no user fees, although it wouldn't surprise me at all if the NBs didn't have to pay a hefty annual "registration" or "licensing"-type fee to their CA...for the privilege of being able to charge their own hefty fees, lol. Regardless, although they may have the authority to audit, evaluate, and grade the NBs, as best as I could tell, under the MDD, the CAs did far did less of that than CDRH does of its not-user-fee-supported/earning inspections. This was, IMO, essentially why the initially voluntary, then mandatory, joint assessments were needed. Up until then, it seemed that many of the CAs were functioning mostly as diploma mills themselves. They didn't actually know what was going on with the NBs they were authorized to to audit, evaluate, and grade. This explains why a flurry of certificates were withdrawn during that time period followed by the ( would guess, long overdue) withdrawal of numerous MDD designations.
Anyway, I'm delighted to have you tease. There's plenty there for everybody, and we will probably never reach the end of it...
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 06-Feb-2020 08:08
From: Michelle Lott
Subject: How many Notified Bodies are "Enough"?
Hi Julie
Thanks for the shout out! As you know #MDRisStillComing with T minus 110 days left to MDR day. I want to tease out a few points in your paper that are adding another dynamic to the politics afoot in MDR designation. You have the following sentence, "The US, for example, has only one "notified body," the FDA." Which isn't quite analogous to the structure in the EU. The individual Competent Authorities and their collective forms (MDCG, EC Commission) are the EU "FDA's" if you will. The Notified Bodies are like designated Third Party Reviewers. Make no mistake, the third party review in the US and the CE mark application in the EU is a for profit business. In the US, you have the option to go direct to FDA or use a third party. The FDA user fees are just enough to keep the meagerly staffed and educated compared the EU where direct to a CA is not an option. The "user fees," if you will, are exorbitant. The Notified Bodies are competing for qualified resources to adequately staff experts for the products in which the have been designated, driving the cost to industry even higher. I suspect there is an economic lesson in here for sure, but I am no economist.
The one and only experience I have had with a client, who pursued a FDA third party review before I got involved with the project, was horrendous. There was zero room for negotiation, full application of guidance documents (even draft ones), even formatting of test reports. They had biocompatibility "experts" that had interpretations that none of my 30-year veteran bioc experts had heard before. You see, third party reviewers turn the submissions they review into the FDA for a final check before clearance. The third party gets graded by the FDA on the correctness and completeness of the submission. Similarly the EU CA's audit, evaluate, and grade the Notified Bodies work in reviewing technical documentation. Should a CA audit result in a bad report card, this counts against the NB being able to maintain designation. Thus the NB's dropping like flies in the last few years. Industry can only expect CE mark reviews to become more exacting - and costly - under MDR.
Those are my thoughts for now. Thank you for the light you are bring to the complications of MDR. The struggle is real.
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Michelle Lott RAC
Principal & Founder
michelle@leanraqa.com
Original Message:
Sent: 03-Feb-2020 19:13
From: Julie Omohundro
Subject: How many Notified Bodies are "Enough"?
As our colleague Michelle Lott keeps diligently reminding everyone on LinkedIn, the days to MDR are numbered, and that number grows smaller every day, a pace that is alarming for many in and around the industry. Everyone is asking how many, how many, how many notified bodies will have been designated under the new regulations this month, next month, by the end of April? End of April??? Yikes!
I'd like to consider a different question: How many notified bodies are "enough"? And for whom?
In theory, only one NB is needed....
[Read more in the attachment]
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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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