FDA and Electronic Documents

From:"Monson, Frederick C."

Afternoon Listers,
	I thought that the information/sites listed herein might be of
interest to many of you, so here it is.

I have been aware of the issue of "acceptability" in electronic
image/document storage and archiving.  What I have not done until now is
search out the sources of useful information so that the issue comes into
greater focus, so to speak.  While the sites listed below are United States
Government sites, the issues, as seen by the government regulators, are
exposed, at least in part.  The most important thing is to note the
complexity of the issues as summarized in the first site.  Hope this is a
welcome sort of sharing.   

See a long summary of the FDA guidelines/requirements at:

URL:  http://www.devicelink.com/mddi/archive/99/05/009.html

FDA Rule:  21 CFR 11 published on 20 Mar, 1997 is the relevant publication.
It considers more than just images.

At the FDA site of the Center for Devices and Radiologic Health, one can
read:  "Guidance for the Submission Of Premarket Notifications for Medical
Image Management Devices"

URL:  http://www.fda.gov/cdrh/ode/guidance/416.html (under "Diagnostic
Imaging" or "Picture Archiving and Communications Systems (PACS)") in the
following FDA Index page.
	or for the PDF:  http://www.fda.gov/cdrh/ode/guidance/416.pdf
	or for the printed document:  call:  1-800-899-0381 and ask for
document 416.

I will know if this is OK with most listers if I don't receive a torrent of
negative responses.


Fred Monson

Frederick C. Monson, PhD   
Center for Advanced Scientific Imaging
Schmucker II Science Center
West Chester University
South Church Street and Rosedale
West Chester, Pennsylvania, USA, 19383
Phone:  610-738-0437
FAX:  610-738-0437
CASI URL:  http://darwin.wcupa.edu/casi/
WCUPA URL:  http://www.wcupa.edu/
Visitors URL:  http://www.wcupa.edu/_visitors/

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