[R] Re: FDA and ICH Compliance of R

Paul Sorenson Paul.Sorenson at vision-bio.com
Fri Nov 28 01:03:52 CET 2003

> "Antonia Drugica" <antoniamarija at net.hr> writes:
> > Does anybody know if R is FDA or ICH (or EMEA...) 
> compliant? AFAIK S-Plus
> > is but that means nothing...
> As Thomas pointed out, that does mean nothing -- there was a group of
> folks discussing what might be done to help, earlier this year, but
> then everyone got busy...

FDA has a guidance document for off-the-shelf software:


Note that if focuses on OTS used in medical devices.  However you
should read it.  The document:


Has a section on applicability of the software guidance (which
encompasses stuff outside the instrument itself.  Since I am no
lawyer, I can't say whether R falls within this scope.

It is fair to say however that the FDA consider safety and
effectiveness very important.  If the effectiveness that you claim is
based on statistics provided by software, or you rely in software for
determining safe levels (eg of a drug) then I would say (as a layman)
it is largely irrelevant whether the vendor claims some sort of "FDA
badge" because that does not prevent someone from writing dodgy

So what you can do (other than soliciting mail list opinions)
	o Think.  What are the implications for end users, patients
etc.  Would you take a pill based on your own stats?  
	o Read what the FDA have to say.  
	o Evaluate the risk and safety implications of the
statistics you use.  
	o Manage the risk.  Eg can you indepently confirm
the key results?  
	o Your scripts are software - the FDA requires
evidence of a credible process in the life cycle of software, whether
they be spreadsheets, real time control systems or whatever.

OTS software that is "validated" does not remove responsibility for
reducing risk to acceptable levels.



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