FDA Finalizes Guidance on Qualifying Device Development Tools; Program May Speed Products to Market

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FDA Finalizes Guidance on Qualifying Device Development Tools; Program May Speed Products to Market

Dennis Tosh

Guide to Medical Device Regulation

August 10, 2017 at 07:35 AM EST

The FDA Aug. 9 released a final guidance document on qualifying medical device development tools (MDDTs). The document formalizes a voluntary agency program through which scientifically validated tools intended to help the development of medical devices can be used by product sponsors “without the need to reconfirm the suitability and utility of the MDDT when used in a premar... Read More

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FDA Finalizes Guidance on Qualifying Device Development Tools; Program May Speed Products to Market

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