may be of great assist to SSH ??May 4, 2016 — The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to generate better evidence more efficiently for medical device evaluation and regulatory decision-making.
May 4, 2016 — The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to generate better evidence more efficiently for medical device evaluation and regulatory decision-making. The agency said a national evaluation system would generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices. The collaborative national evaluation system will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records and medical billing claims. The FDA said such a system will help improve the quality of real-world evidence that healthcare providers and patients can use to make better informed treatment decisions and strike the right balance between assuring safety and fostering device innovation and patient access. The system evolved out of a vision for a medical device post-market surveillance system described in two FDA white papers. The initial report, "Strengthening Our National System for Medical Device Postmarket Surveillance," was issued in 2012 and provides an overview of FDA's medical device post-market authorities and the current U.S. medical device post-market surveillance system. The update to the report, issued in 2013, details the concrete steps that will promote more efficient collection of better and more timely data, helping to identify issues more quickly. Subsequently, FDA issued two five-year program announcements (PAR-13-202 and PAR-13-232) requesting proposals from prospective partners to build the scientific infrastructure and methodology necessary to further develop and implement these plans through cooperative agreements. Under a cooperative agreement with FDA, the Brookings Institution convened a multi-stakeholder planning board
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