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Re: FDA Validation a Threat to Free/OSS?
by Richard Schilling on Monday April 15, @05:50PM
FDA approved medical devices are generally those devices that are connected to a patient, and used by a health care practitioner to make treatment decisions. Any such devices require a high quality of software that meets certain criteria, and the FDA plays an important role in verifying that quality. The approval process keeps bad software out of pacemakers and CAT scan machines. Getting FDA approval is costly, but if specific Open Source based medical devices get that approval, the credibility of Open Source applications will be strengthened. Processing data that originates from existing FDA approved medical devices with Open Source software is a worthwhile effort and would serve the medical community greatly.
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