의료기기 이야기

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..

동국대학교 바이오헬스의료기기규제과학과에서 국내 SaMD 연구개발 동향, 규제 요구사항을 통한 SaMD 제품화 전략 과정 교육을 실시한다. ▶ 일시: 2023년 10월 18일(수) 09시 50분 ~ 16시 30분 ▶ 장소: 포포인츠 바이 쉐라톤 조선 서울역, 20층 세미나실 (서울 용산구 한강대로 366) ▶ 비용: 무료 ▶ 선착순 50명 ▶ 교육대상: 의료기기 산업계 재직자 또는 의료기기 분야에 관심이 있는 자 ▶ 접수방법: 동국대학교 규제과학연구교육센터 교육 홈페이지에서 수강신청 또는 포스트내 QR코드 규제과학연구교육센터 (donggukmdredu.org) 규제과학연구교육센터 donggukmdredu.org

미 FDA에서 510(k) 허가를 위한 서류 제출방식 가이던스를 발간하였다. ▶ 적용시점 FDA is identifying October 1, 2023 as the date on which the 510(k) electronic submission requirements will take effect. ▶ Scope This guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s that enable submission of the 510(k) electronic submission solely in electronic format. The el..

FDA에서 최초로 암 유형의 소인을 평가하기 위한 DNA 테스트에 대한 시판 승인을 하였다. - 업체: Invitae Corporation (미국) - 제품명: Invitae Common Hereditary Cancer Panel - 허가: FDA De Novo (DEN210011) - 제품성능: 9,000개의 임상샘플과 99% 이상의 정확도 - 검체: 혈액 - 47 genes - 검사기간: 10~21일 (보통 14일) FDA Grants First Marketing Authorization for a DNA Test to Assess Predisposition for Dozens of Cancer Types | FDA FDA Grants First Marketing Authorization for a ..

▶ FDA에서 사이버보안관련 가이드라인을 발표하면서 자주하는 질문에 대해 같이 안내함 Cybersecurity in Medical Devices Frequently Asked Questions (FAQs) | FDA Cybersecurity in Medical Devices Frequently Asked Questions (FAQs) Answers to frequently asked questions about cybersecurity in medical devices. www.fda.gov

▶ FDA에서 의료기기 사이버보안과 관련된 가이드라인을 발표함 ▶ 적용해야 되는 인허가 프로세스: 510(k), De Novo, PMA, PDP, IDE, HDE, BLA, IND ▶ 적용제품: Software, Hardware and firmware ▶ 생산 전, 생산 후 단계를 고려하여 품질경영시스템 (QSR)에도 반영 되어야 함 ▶ 인허가를 위해 필요한 서류와 점검 단계를 설명 Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions | FDA Cybersecurity: Quality System Considerations and Premarket Submissions This..