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 with
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
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, instrument, apparatus
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, apparatus or contrivance, including any
component, part
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
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
[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 distribution
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
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