Mark, you make two statement that I don't understand. I'm hoping you clarify them for me.
I one case you that a pre-market inspection "is an illegal requirement for a 510(k)". In another case you say that an "assurance case" standard of review is equally illegal.
I am not an attorney, but from a matter of education, I'm curious to understand the reasoning. For example, in the 510(k) case, I don't think the pre-market inspection is forbidden, just not a common practice. However, I don't see a reason that FDA could not decide to do pre-market inspections on a limited basis (some product codes) or even for all 510(k) devices. Given the resources, it might not be practical, but that is a different issue. Is there a provision in the FD&CA that forbids pre-market inspections for 510(k), therefor making them illegal?
As a corollary, where would a de novo fit? I now think of it as a "peculiar" PMA.
For the assurance case, I see it as a method to demonstrate that a particular device type is safe and effective. Again, I don't see that the method is forbidden, and therefor is allowed.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 16-Nov-2017 07:22
From: Mark DuVal
Subject: Any experience with Pre-Clearance Inspections for External Infusion Pump ?
I dont know if they are doing them or not, but that is an illegal requirement for a 510(k). They also tried experimenting with an "assurance case" standard of review which is equally illegal. FDA was essentially legislating a new standard as an administrative body whose job it is to implement legislative directives. Ed Basile of King & Spalding and I complained about this publicly from the podium. I did it in writing as well. There is no such requirement as a pre-clearance inspection in the statutory 510(k) program. If companies are consenting to it, they shouldn't.
Mark DuVal, JD, FRAPS
President & CEO
DuVal & Associates, P.A.
Sent from my Verizon, Samsung Galaxy smartphone
Original Message------
In their Guidance « Infusion Pumps Total Product Life Cycle » (draft version of April 23, 2010, and final version of December 2, 2014) it is written on page 33 that « FDA may conduct a pre-clearance inspection of infusion pump manufacturers ». In the Guidance it is also explained what might trigger a Pre-Clearance Inspection (i.e., an inspection as part of FDA's 510(k) review process of said devices and prior to clearance). Does anyone know if FDA carrries out such inspections and, if so, what information could you share with me about them ? For the sake of clarity : my company is a developer of external infusion pumps (e.g., an insulin infusion pump) and hence we could be subject to such an inspection. With kindest regards,
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Ary Saaman
Director, Regulatory Affairs
Debiotech S.A.
Lausanne
Switzerland
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