Julie,
Thank you very much for your comments worth a lot more than a dollar.
Several professionals including few CEOs expressed strong interest and accordingly, I wanted to see how RA professionals interpret my proposal. It would appear you didn't get it at all (e.g., inherent meaning), which is good and even better, providing some strong ground for further discussion.
Most of times, what should be doable and is rather advantageous to both the FDA and industry affected can or (even should) be viewed differently at the beginning or even upside down.
I also learned FDA's 510(k) process not in good alignment with the
FDCA.
It takes time to see actionable changes - you have recently observed changes at FDA!!!
As for some of your comments, it warrants some clarification.
As for device "safety," you stated "it has long been recognized that you can't get much in the way of reasonable assurance of safety from a clinical trial." Because of the very reasons that you stated, I proposed in a way to overcome that. Many times, device safety issues can be easily uncovered during device design, bench testing, feasibility studies, animal studies and/or during an early clinical trial, but those safy signals are willfully ignored, just focusing on obtaining an FDA approval or clearance. The safety problems can then be amplified during post-market, recalling or withdrawing the products from the market.
"As someone recently noted in a LinkedIn discussion, clinical trials "create KOLs, clarify physician training, seed the market with eager users, provide favorable publications to create interest, help obtain favorable reimbursement, etc."
Your statements relate to a novel device (e.g., not having reimbursement established), which is outside the meaning and scope of my letter.
When I schedule to give an in-person seminar(s) in DC sometime in the future, I will try to meet with few senators or their staff for further discussion.
s/ David
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Dr. David Lim, Ph.D., RAC, ASQ-CQA Phone (Toll-Free): 1-(800) 321-8567
"Knowledge is power only when it is practiced and put into action." - Regulatory Doctor
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Original Message------
David, I'm not sure I understand the purpose of your letter nor your purpose in soliciting comments on your proposal after the fact.
If the purpose of the letter was simply to put in your two cents, mission accomplished, and nicely done, although it's my understanding that most politicians aren't especially interested in the opinions of citizens who do not vote within their jurisdictions.
If the intent was to persuade them to act on your proposal, I'm rather doubtful that it will achieve that end, but then, I don't know what is required to persuade senators to act on a proposal for legislation, other than--perhaps--large campaign contributions. Since I'm in no position to make large campaign contributions, my approach would be to provide a compelling explanation as to why my proposal has merit, something beyond "it is reasonable to believe."
Regarding your proposal itself, I think steps 1 and 2, like any effort to significantly revise FDA's approach to regulating medical devices, is likely to prove impractical. I have seen less ambitious efforts to improve FDA's processes largely paralyze ODE for an extended period of time. I would expect the effort required to implement these two steps would soak up enough of FDA's resources to bring the review process to a near halt for several years. It's not something I would expect industry to embrace without a near-certainty that the results (i.e., the OSECs) would represent a much lighter regulatory burden. That might indeed be the result, but I don't see this as being inherent in the proposed process.
As for the size and length of clinical trials needed to provide reasonable assurance of the safety and effectiveness of medical devices, it has long been recognized that you can't get much in the way of reasonable assurance of safety from a clinical trial. This is what underlay the seeming irony of the Kefauver Harris amendment, which responded to a safety issue by requiring a demonstration of efficacy. The politicians had to do something, and you can get a decent first-pass assessment of efficacy in a clinical trial, where you can't learn that much about safety. The latter is the argument for a strong post-market surveillance program, and it is here where I think there is potential for reducing the length of some trials. As, apparently, does FDA.
In any case, I think the argument over the appropriate design and size of device trials is now moving past FDA. As someone recently noted in a LinkedIn discussion, clinical trials "create KOLs, clarify physician training, seed the market with eager users, provide favorable publications to create interest, help obtain favorable reimbursement, etc. etc. Any good regulatory clinical study is designed and executed with all these other goals in mind and fully supported; not just the narrow goal of getting a regulatory approval."
My two cents. Or maybe more like a dollar. :)
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Julie Omohundro RAC
Durham NC
United States
Original Message:
Sent: 08-21-2015 15:23
From: David Lim
Subject: My Letter to Three US Senators - Your Comments Appreciated!
Dear Fellow Members,
I have recently written a letter, dated July 27, 2015, to three honorable US senators, intending to propose a potential BILL.
When you get a chance to read my letter, I'd very much welcome any of your comments to me, especially if you disagree (including your ground to objection).
My letter can be downloaded here >>
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Dr. David Lim, Ph.D., RAC, ASQ-CQA
President and CEO | REGULATORY DOCTOR
http://www.RegulatoryDoctor.US
http://www.GlobalComplianceSeminar.com
Phone (Toll-Free): 1-(800) 321-8567
E-mail: David@RegulatoryDoctor.US
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