FDA Validation a Threat to Free/OSS?

Arnaud Le Breton wrote in asking about the ‘regulatory aspects’ of medical open source especially in view of the FDA’s recent revised document “General Principles of Software Validation: Final Guidance for Industry and FDA Staff” which includes the following statement: ‘…computer systems used to create, modify, and maintain electronic records and to manage electronic signatures are also subject to the validation requirements. (See 21 CFR �11.10(a).) Such computer systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.’ This could be VERY bad for the fledgling free and open source medical software industry if they have to pay for such validation. The complete text of Le Breton’s letter and discussion is within:

Hello,

First let me thank you for your informative linuxMedNews page.

The plan was to use GNU/LINUX as the OS for a medical device. I’ve developed only on Unixes systems and is fervent Linux enthusiast.

Linux seems like a rather nice choice, as you already know I guess :), but I came to realize that my lack of experience with medical issues has prevented me to foresee the regulatory aspect of the project, which I have been reminded of recently.

To make this mail short, I have gotten hold of the document issued by the FDA, entitled “General Principles of Software Validation : Final
Guidance for Industry and FDA Staff”
.
It is a more complete version of the draft from 1997, and is more general then the document about Off-The-Shelf software use in medical devices from 1999.

I understand that the liability problem is important, but I fear that those legislation may prevent the free software model to succeed within medical software close to the patients (I think about the Linux Anaesthesia Modular Devices Interface, aka LAMDI project for example, that should not be used on humans).
(http://www.umanitoba.ca:8080/lamdi/index_html)

I took the chance to email as you are probably very updated about this topic, in hope to get some information, and your point of view about all this.

I am wondering starting up a project in order to maybe join forces between several people/companies interested in Linux or Free SW in
general for use in the medical sector, and medical device (Linux Medical Consortium, or something similar).

Thanks in advance for any informations or comments you may share with me, especially if you already know of devices that use Free software
and that have obtained an FDA approval.

Best Regards,

— arnaud LE BRETON

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