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 Is FDA approval required to post files?
Not unless you specifically state that the files are for clinical use. By default, all files are distributed under the MIT license as research or educational tools with no fitness guarantee. This means that it is the responsibility of the downloader to evaluate every file for accuracy, as well as only use files as research or educational tools. While several types of products are exempt from FDA 510k approval, such as [url=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=892.5050]film dosimetry systems used as quality control of a radiation therapy system[/url], not all are exempt from Good Manufacturing Practices (GMPs). If you have any doubt when uploading files, do not specifically state that the files are intended for clinical use. Products for research and educational uses are not regulated by the FDA, as they are not classified as "medical devices". Links to FDA guidelines: [url=http://www.fda.gov/cdrh/devadvice/31.html]Is my product regulated by the FDA?[/url] [url=http://www.fda.gov/cdrh/devadvice/312.html]Is my product a medical device?[/url] [url=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=892]Specific FDA 510k and GMP exemptions[/url]...


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Unless otherwise specified, all files are distributed under the MIT open source license for research and educational use only with no fitness guarantee.
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