FYI:
--
-- Ignacio Valdes,MD,MS Editor: Linux Medical News
http://www.linuxmednews.com
'Revolutionizing Medical Education and Practice'
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A posting has been added to the following site which you moderate:
'GNU/Linux And Open Source Medical Software News'.
In response to "FDA Validation a Threat to Free/OSS?",
Brian Gorbe wrote:
I have been involved for years with software validation under FDA regulations. I have
just a
few observations: 1. FDA's primary concern is patient safety. When it comes to
software,
devices, drugs, whatever, they will evaluate the risk to safety in determining how much
testing, control, and validation is required. 2. In classifying software (or anything
else)
as a medical device, patient contact is not required. Bloodbank software (i.e.,
tracking
donors and blood types) is classified as devices by FDA and such software must be
registered
with FDA. The issue is safety. Corrupted bloodbank records could result in someone
receiving
the wrong blood type. 3. The end-user is ALWAYS responsible for validating the SYSTEM
as it is
used. A software vendor cannot claim that their software is "validated" and relieve the
end-user of that responsibility. A vendor cannot test all applications of their
product on
all possible hardware using all possible operating systems. So it is up to the
end-user to
validate the software on their hardware with their OS in the manner they will use the
software
(e.g., if they will not use a certain feature, they do no have to validate that
feature). The
end-user can contract out the actual work, as long as the end-user takes
responsibility for
the work (i.e., reviews and approves protocols, reports, etc.). Please note that the
end-user may be an institution, department, or specific person. 4. FDA considers
software
validation to encompass the entire development life cycle. Requirement documents,
design
documents, commented source code, and test documents are all part of the validation
package.
The more of these documents the developers/vendors can supply the end-user, the easier
it is
to validate and the happier FDA will be. 5. In the 1980's there was contention between
FDA,
industry (primarily drug manufacturers), and vendors over the availability and
inspection
of source code. FDA backed off (who could compel Microsoft to release the source code
to
Excel?). Open source software has the advantage of meeting FDA's concerns and relieving
industry of various NDA and escrow entaglements.
The new posting may be found at
http://www.linuxmednews.org/linuxmednews/1018893577/1019153129
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