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Re: Product Liability Case To Be Heard SoonFrom: DoctorJoe@aol.comMon Nov 19 13:40:55 2007
In a message dated 11/19/2007 2:14:42 P.M. Central Standard Time, dean@thehuffpeople.net writes: The MDA generally forbids states from imposing requirements on devices that received premarket approval from the Food and Drug Administration ("FDA"). Well, I think they're toast. The law specifically states that the states can't add to the regulation of the device unless there are some "compelling local conditions" which would make it necessary. I don't know what "local" condition exists that would allow some imposition on an angioplasty device. Maybe you think doctors in one state are more spastic than doctors in another and so ... Naw! Further, even if there was a good argument for a local difference, the State has to formally apply for a waiver and have a hearing, etc. That (apparently) hasn't been done. So avenues are available for reasonable State regulation -- just not done and probably not needed in this case. Federal law rules. At least in my opinion here. Joe P. ************************************** See what's new at http://www.aol.com -------------------------------1195504824 Content-Type: text/html; charset="US-ASCII" Content-Transfer-Encoding: quoted-printable <!DOCTYPE HTML PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN"> In a message dated 11/19/2007 2:14:42 P.M. Central Standard Time,
dean@thehuffpeople.net writes:
The MDA generally forbids states from Well, I think they're toast. The law specifically states that the states
can't add to the regulation of the device unless there are some "compelling
local conditions" which would make it necessary. I don't know what "local"
condition exists that would allow some imposition on an angioplasty device.
Maybe you think doctors in one state are more spastic than doctors in another
and so ... Naw!
Further, even if there was a good argument for a local difference, the
State has to formally apply for a waiver and have a hearing, etc. That
(apparently) hasn't been done.
So avenues are available for reasonable State regulation -- just not done
and probably not needed in this case. Federal law rules.
At least in my opinion here.
Joe P.
See what's new="_blank">Make AOL Your Homepage.
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