April 15, 2002

FDA validation a threat to Free/OSS?

I. Valdes writes, "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 here at LinuxMedNews.com."
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