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FDA’s Breakthrough Device Program: Opportunities and Challenges for Device Developers

As part of the 21st Century Cures Act, Congress gave the US Food and Drug Administration (FDA) the authority to establish a Breakthrough Devices Program intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. In December 2018, FDA issued a guidance document describing policies FDA intends to use to implement the Program. There are two criteria for inclusion in the Breakthrough Device Program: The device must provide for a more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition; and The device must (i) represent breakthrough technology, (ii) have no approved or cleared alternatives, (iii) offer significant advantages over existing approved or cleared alternatives, or (iv) demonstrate that its availability is in the best interest of patients....

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FDA Aims to Expand Sentinel Capabilities, Include Evaluation of Drug Effectiveness

At a recent public workshop, Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), announced plans to expand the agency’s use of the Sentinel infrastructure to conduct post-market effectiveness studies. Sentinel is an electronic surveillance system that aggregates data from electronic medical records, claims and registries that voluntarily participate and allows the agency to track the safety of marketed drugs, biologics and medical devices. As of August 2015, the Sentinel database includes information from 193 million individuals, 4.8 billion instances of prescription dispensing, 5.5 billion unique encounters and 51 million acute inpatient stays. The FDA currently uses the system to assess post-market safety issues. However, in a February 3, 2016, workshop, Dr. Woodcock announced that the FDA is in the early stages of adapting the Sentinel infrastructure to develop the “Guardian” system,...

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