의료기기 이야기

한국보건산업진흥원에서 의료기기 제조업체를 대상으로 해외 수출을 지원하고자 세미나를 진행한다. ▶ 날짜: 2023년 12월 13일(수) 10:00 ~ 15:30 ▶ 장소: 한국사회복지회관 대회의실 (서울 마포구 만리재로 14, 르네상스타워 6층) ▶ 선착순 100명 ▶ 중식제공 ▶ 세미나: 의료기기 미국시장 진출 및 FDA 해외펀딩 전략 메드텍 수출지원 협의체 유럽인증 획득 세미나 메드텍 수출지원 협의체 연계 해외시장 진출(미국, 유럽, 호주) 세미나 개최(12.13(수) 10:00~15:30, 한국사회복지회관) 기관별 교육·행사>알림마당-의료기기산업정보 종합정보시스템 (khidi.or.kr) 메드텍 수출지원 협의체 연계 해외시장 진출(미국, 유럽, 호주) 세미나 개최(12.13(수) 10:..

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..

[요약] 코로나때 긴급하게 사용되었던 원격모니터링 장비/기기에 대한 FDA 정책 변화를 가이던스로 발표하였다. FDA is issuing this guidance to provide clarification on its enforcement policies and premarket review expectations for certain non-invasive remote monitoring used for patient monitoring at the conclusion of the COVID-19 public health emergency. FDA believes the policy set forth in this guidance may help FDA and other stakeholders tra..

The FDA Oncology Center of Excellence (OCE) in conjunction with the European Medicines Agency (EMA) will host a Conversations on Cancer public panel discussion October 19, 2023, addressing the experience of living with metastatic breast cancer. The panel will feature speakers with a range of perspectives on breast cancer and, for the first time, will be an international collaboration with our co..

This guidance document provides Food and Drug Administration’s (FDA’s or the Agency’s) recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. This guidance applies to all medical devices that might be used in the M..

This guidance document provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This document is intended to be used in conjunction with information regarding the content and format of a 510(k) premarket notification. The approach outlined in this guidance document is intended to facilitate the timel..

Each year, the Center for Devices and Radiological Health (CDRH) posts two lists of guidance documents that it intends to publish during the fiscal year. These lists are: The A-list: A list of prioritized guidance documents that the Agency intends to publish during the fiscal year. The B-list: a list of guidance documents that the Agency intends to publish as resources permit during the fiscal y..

This is a list of nucleic acid-based tests that have been cleared or approved by the Center for Devices and Radiological Health. These tests analyze variations in the sequence, structure, or expression of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) in order to diagnose disease or medical conditions, infection with an identifiable pathogen, or determine genetic carrier status. Nucleic ..

FDA updated of the list of cleared or approved companion diagnostic devices (in vitro and imaging tools). - Device: CRCDx RAS mutation detection assay kit - Generic name: somatic gene mutation detection system - Applicant: EntroGen, Inc - PMA number: P220005 - Approval order statement Approval for the CRCdx® RAS Mutation Detection Kit. The device is a qualitative real-time PCR in vitro diagnosti..