Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to advance medical device innovation and help patients gain faster access to beneficial technologies

FDA

24 October 2017 - Enabling patients and providers to have efficient access to new and innovative medical products that meet the FDA’s gold standard for safety and effectiveness is a core part of our mission. 

We’re advancing these goals as part of the Medical Innovation Access Plan that I announced earlier this year. While we’ve unveiled parts of that plan already, we’ll be releasing its full detail shortly. As one part of that effort, we’re announcing some additional steps we’re taking right now to promote beneficial medical device innovation.

Medical device technology evolves quickly. The process for improving the performance and clinical characteristics of medical devices is highly iterative. Often it’s the case that small modifications help provide incremental but meaningful improvements to products. Over time, these cumulative advances are consolidated into more noticeable advances in the performances of different technologies. Therefore it’s important for the FDA to enable innovators to have the flexibility to efficiently make these kinds of small modifications. At the same time, the FDA needs to establish modern tools and benchmarks for measuring the safety and performance of devices to make sure they’re delivering the expected benefits to patients.

Read FDA statement

Michael Wonder

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Michael Wonder