Original Message------
AHA - I see the question probably should have been interpreted as if a valid compliant study has ended.
The protocol should have addressed how the subjects would be tracked and monitored and explanted if needed. This is just as the labeling of an approved implant would be. If the protocol does not, that would be unusual these days; but you'll probably have to go back and update the informed consent to address this. Changed circumstances (new safety information, newly identified procedures) often require an update.
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Andrea Chamblee Esq., RAC, FRAPS
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.
Silver Spring MD
United States
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Original Message:
Sent: 09-10-2015 07:21
From: Ginger Glaser
Subject: Revised Federal Policy for the Protection of Human Subjects
Interesting, I interpreted the original question totally differently, in that I assumed they had appropriate approvals for the study (IDE etc) but then chose not to move forward with commericializing the device. In this case, there are no laws about "marketing approvals" broken in any way. The situation can also come up in an FDA approved "compassionate use" device but very rarely.
In either of these cases, the obligations to the patients are similar to those of any clinical study patient. The content should be a study consent or something very similar, which clearly states this is not a marketed device. When there are safety issues, or other complications, the consent should spell out how they will be dealt with.
The few times I have run into this challenge, we have chosen to hold ourselves to the same obligations as we have with our approved devices.
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Ginger Glaser RAC
Vice-President, Global Regulatory Affairs
American Medical Systems Inc
Minnetonka MN
United States
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Original Message:
Sent: 09-09-2015 09:27
From: Andrea Chamblee
Subject: Revised Federal Policy for the Protection of Human Subjects
If a medical device manufacturer implants a device, does not obtain marketing approval and stops development, does the manufacturer have any legal, regulatory or moral obligation to the subjects who are walking around with the implant?
People engaged in this conduct are generally subject to state laws against assault and battery and failure to warn, which can be criminal (fines/jail) as well as civil (damages). Compliance with FDA and Informed Consent pre-empt those state requirements (See Medtronic, Inc. v. Lohr, Riegel v. Medtronic)
If the manufacturer/practitioner does not comply, s/he can be sued in every state where there was a patient, as well as lose any licenses to practice. Insurance would probably not protect the manufacturer, since any illegal acts are not covered. It sounds like a world of hurt.
There are several cases involving the use of unapproved implants. The somewhat lurid criminal cases involving cosmetic surgery implants come to mind. http://www.dallasnews.com/news/crime/headlines/20150805-st.-louis-area-authorities-illegal-buttocks-injection-death-could-be-linked-to-dallas-case.ece
What is standard of care for informed consent to protect subjects?
Unlike general practice, where the standard is in the best interest of the patient, legally conducted clinical trials generally do not involve customizing treatment for the patient. The patient needs to be informed the protocol will be followed even when their individual case might merit a change in the regimen.
The beginning of 21-st century saw an increased number of lawsuits related to human research: Grimes v Kennedy Krieger Institute; Robertson v. McGee, Gelsinger v. Trustees of the University of Pennsylvania, Weiss vs Solomon, Quinn v. Abiomed.
Good luck!
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Andrea Chamblee Esq., RAC, FRAPS
This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.
Silver Spring MD
United States
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Original Message:
Sent: 09-08-2015 09:01
From: Nancy Chew
Subject: Revised Federal Policy for the Protection of Human Subjects
If a medical device manufacturer implants a device, does not obtain marketing approval and stops development, does the manufacturer have any legal, regulatory or moral obligation to the subjects who are walking around with the implant?
What is standard of care for informed consent to protect subjects?
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Nancy Chew RAC
President
Regulatory Affairs, North America, Inc.
Durham NC
United States
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Original Message:
Sent: 09-04-2015 15:12
From: David Lim
Subject: Revised Federal Policy for the Protection of Human Subjects
The US DHHS with 15 other federal agencies announced the proposal to revise the federal policy for the protection of human subjects.
It is intended to to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.
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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