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The FDA has been working with COVID-19 test developers seeking to pursue marketing authorization through the traditional premarket review pathways, which will allow these tests to continue to be used beyond the time allowed by emergency use authorization.  This page lists COVID-19 tests that have received traditional marketing authorization. See the Marketing Your Device page for more informatio..

Since graduating from medical school in 1978, I’ve seen medicine and healthcare change in unimaginable ways for the better. However, one of the most alarming changes is the recent decline in life expectancy in our country, largely due to the cumulative impact of common chronic diseases (CCDs), combined with excessive rates of suicide, drug overdose and gun violence, and, of course, COVID-19. How..

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories (OSEL), CDRH  Today, the FDA’s Center for Devices and Radiological Health (CDRH) is announcing a partnership with the Bill and Melinda Gates Foundation to create new analytical met..

SummaryOn July 16, 2024, the U.S. Food and Drug Administration (FDA) will host a webinar to discuss how in vitro diagnostic products (IVDs) are classified by the FDA.  If you have questions that you wish to submit for possible discussion during the webinar, please email CDRHWebinars@fda.hhs.gov. All questions must be received by June 28, 2024, to be considered for the discussion. Questions will ..

As artificial intelligence continues to evolve, we are seeing revolutionary opportunities to enhance health care, especially through machine learning. AI can be applied across the spectrum of health applications, including for the prevention, diagnosis, and treatment of a variety of medical conditions, as well as for a range of administrative tasks. Health products, including those that are medi..

Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together The U.S. Food and Drug Administration (FDA) issued "Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together," which outlines the agency's commitment and cross-center collaboration to protect public health while fostering responsible and ethical medical product..

2023년 11월 15일자로 FDA에서 사이버보안과 관련된 내용을 추가 발표하였다 (Updated). [세부내용] November 15, 2023 – The FDA contracted with MITRE to develop the report, Next Steps Toward Managing Legacy Medical Device Cybersecurity RisksExternal Link Disclaimer. Legacy medical devices are those that cannot be reasonably protected against current cybersecurity threats, and these devices can pose significant risks to the health ..

Emergo by UL 에서 미국 US FDA Pre-Submissions에 대한 웨비나를 진행한다. 최근에 FDA에서 변경된 Pre-submission에 대해 설명하고 각 제조업체에서 준비해야 되는 사항에 대해 설명할 것으로 예상된다. ▶ 일자: 2023년 11월 09일(목) 자정 (0시, CST 기준 오전 9시) ▶ 온라인으로 1시간동안 진행 예정 ▶ 링크: U.S. FDA Pre-Submissions | Emergo by UL U.S. FDA Pre-Submissions In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest insights about U.S. FDA Pre-Submiss..

미국 FDA (식품의약품안전처) 내부 CDRH 부서에서 국제규격과 미국 내부 규정과의 조화 (harmonization)를 위한 계획안을 발표하였다 (draft strategic plan). ▶ Mission It is CDRH's mission to protect and promote the US public health. From an international perspective, this means integrating the US into the international medical device ecosystem. To do so, we develop and foster relationships with other regulatory authorities and strategic partners..