Hi Andreas,
Answers to your extremely important questions below.
On 08/18/2014 11:38 PM, Andreas Tille wrote:
Hi Ira,
On Mon, Aug 18, 2014 at 01:42:51PM -0700, Ira Kalet wrote:
I had the good fortune at a recent social event to meet an attorney
for one of the big multinational corporations i
Hi Ira,
On Mon, Aug 18, 2014 at 01:42:51PM -0700, Ira Kalet wrote:
>
> I had the good fortune at a recent social event to meet an attorney
> for one of the big multinational corporations in the medical device
> business, whose job is to look after FDA regulatory issues. He even
> was familiar wi
On 08/11/2014 08:03 AM, Ian Jackson wrote:
Steve M. Robbins writes ("Re: Status of uw-prism packaging for Debian"):
My guess is that the legality of distribution hinges on how the software is
represented. For example, [1] defines "device" as:
any article, inst
Steve M. Robbins writes ("Re: Status of uw-prism packaging for Debian"):
> My guess is that the legality of distribution hinges on how the software is
> represented. For example, [1] defines "device" as:
>
> any article, instrument, apparat
Hi,
I'm tuning in late, but regarding Ira Kalet's question:
> 3. Finally, there is still the issue of what the US FDA might say
> about distribution within the US,
We have to worry about more than just the US. Almost every country regulates
the marketing of medical devices.
> as software pr
On 8/1/2014 1:56 AM, Andreas Tille wrote:
> What do you think?
>From http://www.gpo.gov/fdsys/pkg/FR-1998-02-02/html/98-2498.htm
and
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369431.html
I can't tell if 510(k) clearance would be required, or not.
That is why you need to talk
On Fri, Aug 1, 2014 at 4:56 PM, Andreas Tille wrote:
> I'm forwarding a part of a discussion to you legal experts for
> clarification:
I'm afraid debian-legal is mostly armchair lawyers. If you want to
consult actual lawyers, it would be best to get legal advice from the
SFLC, who we have gotten
[Please keep Ira Kalet and the Debian Med mailing list in CC]
Hello,
I'm forwarding a part of a discussion to you legal experts for
clarification:
On Thu, Jul 31, 2014 at 11:15:49AM -0700, Ira Kalet wrote:
> >
> >>3. Finally, there is still the issue of what the US FDA might say
> >>about distri
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