Advancing Regulatory Science to Bring Novel Medical Devices for Use in Emergency Care to Market: The Role of the Food and Drug Administration

Working With the Food and Drug Administration's Center for Devices to Advance Regulatory Science and Medical Device Innovation

“…To accomplish this goal, CDRH is actively engaged in advancing “regulatory science” for use in the product development and review process. Regulatory science research and practices provide industry and FDA with scientifically based assessment tools and approaches that can assist in the development, manufacture, and evaluation of new devices and technologies, as well as the creation of more efficient regulatory pathways . Most of the 1600 CDRH staff members (which include scientists, engineers, clinicians, statisticians, and public health specialists) support regulatory science processes by: (i) developing new standardized test methods and computational modeling techniques through laboratory‐based device research; (ii) analyzing premarket bench, animal, and clinical trial testing and data for new devices; (iii) improving surveillance and epidemiological methods for monitoring and studying devices already on the market; (iv) preparing regulatory‐based information and guidance documents to assist industry; and (v) bringing together interested parties and experts to address challenges in device development and assessment.…”

Recent Advances in Medical Device Triage Technologies for Chemical, Biological, Radiological, and Nuclear Events

“…Studies have shown modest increases in triage performance using smart physiological monitoring devices 6 . Since 2010, the US Food and Drug Administration (Silver Spring, Maryland USA) has committed to regulatory science in accumulating scientific knowledge regarding the safety and efficacy for evaluating devices anticipated to be used in CBRN events 25 . A paradigm for advancing technology is that it should be well funded and run parallel with policy and procedure development in order to keep pace and remain current.…”

Public Understanding of Medical Countermeasures

“…Caucasians had higher trust in the government and the CDC compared to African Americans .000 * P* = Bonferroni adjusted significance level determined by a/n, where N is the number of planned comparisons. 3 The critical value becomes .017.…”

“…1,2 Ongoing research is developing medical countermeasures deployable in public health emergencies, enabling the best emergency medicines and tools to be available when disaster strikes. 3 According to the FDA, 1 about 26 different EUAs were in use to address public health emergencies at the time the study was conducted: Zika virus (6), enterovirus D68 (1), respiratory syndrome coronavirus (2), and anthrax (2). These numbers do not include the archived EUAs for Ebola virus (6), Middle East respiratory syndrome coronavirus (1), H1N1 influenza (4), and anthrax (1), in addition to past public health disasters without authorized or available EUAs such as the Fukushima nuclear disaster.…”