Hardhats:
The following information was provided by Jim Callahan at my request for
help in answereing Rusty Maynard's question earlier. Jim represents FDA on
Clinical Lab Standards Institute committees on Lab Automation and
Informatics Standards in DC. He may be a source useful to the World VistA
programs held in DC in either speaking on Lab Module issues or helping
to arrange appropriate speakers on imaging issues realting to the VistA
architecture, I hope this will be useful.
Arden W. Forrey PhD
Dept of Restorative Dentistry
University of Washington School of Dentistry
206-616-1875 Phone
206-543-7783 FAX
---------- Forwarded message ----------
Date: Wed, 31 Aug 2005 09:53:53 -0400
From: "Callaghan, Jim" <[EMAIL PROTECTED]>
To: 'A. Forrey' <[EMAIL PROTECTED]>
Subject: RE: [Hardhats-members] Re: VistA Imaging FDA and NonCommercial Us e Re:
[Hardhats-members] Re: TIU Interface for Document Scanning ( fwd )
Arden
Since I am looking at this from a clinical laboratory perspective a good
starting point for me is to direct you to information on how the Office of
In Vito Diagnostic Devices (OIVD) regulates clinical laboratory automation
found at: http://www.fda.gov/cdrh/oivd/regulatory-overview.html#9b another
FDA site dealing specifically with Imaging is "Guidance for the Submission
of Premarket Notifications for Medical Image Management Devices" at:
http://www.fda.gov/cdrh/ode/guidance/416.html.
Decisions on how OIVD would regulate any laboratory imaging device would be
based the information contained in the above sites, past decisions and
appropriate regulations. Imaging components for medical use are considered
medical devices and would be subject the Quality Systems regulations under
21 CFR 820 especially design controls.
In addition medical devices are regulated according to their intended use. A
non-diagnostic image storage and communications device used in the clinical
laboratory, most likely would be viewed by OIVD as a class I type device,
exempt from the premarket notification [510(k)] requirements of the Act,
subject to the limitations to the exemption found in 21 CFR 862.9. A
clinical laboratory imaging device which is diagnostic or a diagnostic aid
would be regulated according to the 21 CFR 862, 864 and 866 classification
regulations for the intended use and per any special controls for the
described imaging device. Classification of specific uses beyond the
clinical laboratory would be subject to other classification regulations
that cover the other specific use.
I'm not addressing the subject of closed loop verses open loop in 21 CFR 11,
but closed loop verses open loop; i.e. human intervention, is a concept put
forward several years ago for the in regulation of computer products, and I
believe it is no longer popular in CDRH.
Hope this is helpful.
Jim
This communication is consistent with 21 CFR 10.85(k) and constitutes an
informal communication that represents my best judgment at this time but
does not constitute an advisory opinion, does not necessarily represent the
formal position of FDA, and does not bind or otherwise obligate or commit
the agency to the view expressed.
Jim Callaghan, MT (ASCP)
Medical Technologist
Senior Scientific Reviewer
Food and Drug Administration
Center for Devices and Radiological Health
Office of In Vitro Diagnostic Device Evaluation and Safety 240.276.0443
************************************
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-----Original Message-----
From: A. Forrey [mailto:[EMAIL PROTECTED]
Sent: Friday, August 12, 2005 11:29 AM
To: jim callahan
Subject: Re: [Hardhats-members] Re: VistA Imaging FDA and NonCommercial Use
Re: [Hardhats-members] Re: TIU Interface for Document Scanning (fwd )
Jim:
Within the group working on adaptation of VA's VistA to non-VA care
settings, the issue has arisen about its IMaging module and the potential
control the FDA might exert about how image management components of a
health information architecture could be used and distributed. The issue
of open software distribution is involved whether via a Supplier or an
Acquirer. I commented to this group that the FDA is primarily interestrd
in contolling devices that have closed control loops that do not included
human decision making. Can you enlighten this and give a refrence to the
appropriate laws and regulations along with a conservative policy
statement an POC for those with further interest. This issue does relate
to the clinical lab and measurement devices that may have related
behavior. In addition to passing oon your information to this VistA group,
I will pass it on to the AACC LISMID for circulation to the Division and
other AACc individuals who may have an interest so that folks are
operating on factual information and not heresay. Hopefully, this quick
synopsis will not cause you much additional work but will calarify this
important issue for many.
Sincerely,
Arden W. Forrey PhD
Dept of Restorative Dentistry
University of Washington School of Dentistry
206-616-1875 Phone
206-543-7783 FAX
---------- Forwarded message ----------
Date: Thu, 11 Aug 2005 18:50:05 -0400 (EDT)
From: Tyrus Maynard <[EMAIL PROTECTED]>
Reply-To: hardhats-members@lists.sourceforge.net
To: hardhats-members@lists.sourceforge.net
Subject: Re: [Hardhats-members] Re: VistA Imaging FDA and NonCommercial Use
Re: [Hardhats-members] Re: TIU Interface for Document Scanning
This was discussed on a long thread in May 2004 at the topica.com site in
which I cited some of the FDA links after struggling to put them in a
context.
http://lists.topica.com/lists/hardhats/read/message.html?mid=910130973
In the use of language about *closed* or *open*, do you mean Title 21
Part 11 ? This part seems to be concerned only with FDA defining under what
circumstances it will accept Electronic records in lieu of paper records
whenever a given party is submitting data to comply with any regulatory
review or approval.
This soothes my belief that FDA is not charged with regulating medical
record systems in medical practices.... even if viewing any image involves
some generic technology (whether it be adjusting ambient light in a room or
adjusting pixels on your monitor). I would like to believe that generic
technology is not a medical device, at least once the given
procedure is completed and archived...and ...I would be disappointed if
medical practice did not leverage generic technology while keeping FDA busy
with other more critical beats.
Here is the link to Title21 Part 11 Do a *Find* on "closed" and "open"
and the discussion is not very enlightening....hardly a mandate for FDA to
scrutinize medical records software as if record keeping and subsequent
access and display of images constitutes a device.
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=ebf33225bf8a91b5c94
3d06831b245ce&rgn=div5&view=text&node=21:1.0.1.1.7&idno=21
Is there another place where FDA discusses the open/closed paradigm which
you describe as a *cognitive loop*?
Rusty Maynard
(from A Forrey)
The FDA has repeated said that the difference of a device from other
non-regulated software is whether its control capability has the
inclusion of an open cognitive loop that precedes the control of a
device. In any particular situation the can be consulted to determine
whether this control criterion has been met. Display software (text or
otherwise) that involves human interpretation is generally considered
and open loop.
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