FDA Medical Device Tools Pilot Program

FDA initiated this pilot program as a way to quality fools for use by device manufacturers in their develpment processes. Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use. It focuses on cliinical outcome, biomarker, and non-clinical assessment models. FDA’s webpage on this pilot program is at the link provided. Since FDA will keep proprietary information confidential this approach may be attractive to tools vendors that want an FDA qualification statement but want to protect their proprietary information and not provide it to device manufacturers.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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