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Accelerating Medical Device Innovation with Regulatory Science Tools

Topic: Accelerating Medical Device Innovation with Regulatory Science Tools

Progress in science and technology offers extraordinary opportunities to develop innovative medical products that can save lives and lead to better treatments, better diagnostics and better care for patients. The U.S. Food and Drug Administration is committed to advancing the public health by helping to bring innovative technologies to market and assuring that medical devices already on the market continue to be safe and effective.

As the rate of technological advances moves faster than the science for evaluating the benefits and risks of new products, the FDA’s Center for Devices and Radiological Health (CDRH) is helping to ensure that device developers have the right test methods to evaluate new innovations. The Catalog of Regulatory Science Tools collates a variety of regulatory science tools that CDRH’s Office of Science and Engineering Labs (OSEL) has developed, with new tools added as they become available. These methods expand the scope of innovative science-based approaches to improve the development and assessment of emerging medical technologies. The catalog includes more than 100 tools, including laboratory methods, tissue-mimicking phantoms, and computational modelling and simulations.

Why Regulatory Science Tools in Addition to Standards and MDDTs?

The FDA recognizes voluntary consensus standards to facilitate meeting requirements under statute or regulations. The use of FDA-recognized consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, facilitate market entry for safe and effective medical products, and promote international harmonization. However, standards take a long time to gain consensus and often are not approved until the particular medical device category is well-established, which means that early developers do a lot of the “heavy lifting.”

The FDA’s Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device developers can use in the development and evaluation of medical devices. 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. (The list of qualified MDDTs can be found on FDA.gov.) Although the MDDT qualification program is not meant to replace the consensus standard development and recognition process, the FDA views the MDDT qualification program as a complementary program for evaluating and recognizing tools that are useful for medical device evaluation and to support regulatory decision-making.

Topic Discussed: Accelerating Medical Device Innovation with Regulatory Science Tools

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