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RE: New FDA Software Regulations 1/11/02



On Tue, 29 Jan 2002, John S. Gage wrote:
...
> http://www.fda.gov/cber/gdlns/esigvalid.pdf
>
> one comes away with the impression that one has tiptoed past the
> graveyard.  The validation requirements do *not* seem to apply to
> electronic patient records, *except* when those records are used in
> federally funded research.

John et al,

1)  My reading of the regulations (21 CFR Part 11) indicates that (under
the heading=Applicability) the regulation does not apply to clinical
information sytems - but are limited to systems that are used to
manufacture, produce, develop medical devices/drugs regulated by the FDA.

I quote

"Validation requirements apply to software used as components in medical
devices, to software that is itself a medical device, and to software used
in production of the device or in implementation of the device
manufacturer's quality system"

As far as I know, medical record systems are not medical devices!! Is this
contrary to anyone's understanding?

2)  Regarding in-house vs. off-the-shelf systems, the regulation includes
a detailed discussion on this exact issue under section 2.4. The short
answer is that the regulation does not make an exception as to route of
acquisition.

> Comments?

I like it. There is no reason why any open source project would not wish
to follow the validation steps specified in these documents. Even if the
regulation does not apply, there are good reasons to believe the
validation process will have many benefits. See Section 3.4, Benefits of
Software Validation (page 9) :-).

Thanks John,

Andrew
---
Andrew P. Ho, M.D.
OIO: Open Infrastructure for Outcomes
www.TxOutcome.Org (Hosting OIO Library #1 and OSHCA Mirror #1)



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