의료기기 이야기

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..

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 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..

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..

FDA에서 'Digital Health' 제품관련 자주하는 질문에 대한 공식적인 답변을 게재 12개 자주하는 질문에 대해 답변 Digital Health Frequently Asked Questions (FAQs) | FDA Digital Health Frequently Asked Questions (FAQs) We encourage you to review our list of FAQs on this page and explore the FDA’s many publicly available resources online to help answer your general questions. www.fda.gov

FDA에서 이전부터 적용해 왔던 ISO 10993-1 관련 가이던스 발행 평가시 고려사항, 필요항목, Flow Chart 등에 관하여 자세히 설명 Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" | FDA FDA’s Biocompatibility Guidance on Use of ISO 10993-1 This guidance provides clarification and updated information on the use of ISO 10993-1 to support PMAs, ..

FDA에서 '23andme' 회사에서 발행하는 'BRCA1/BRCA2 (Selected Variants)' 개인게놈서비스 유전건강위험보고서의 마케팅을 승인 이 보고서를 바탕으로 관련 분야 전문가 (Healthcare professional)와 논의 필요 함 암검진이나 건강관리를 위해 이 보고서의 결과를 사용해서는 안 되며, 치료결정에도 사용해서는 안 됨. 개인게놈서비스: PGS (Personal Genome Service) 유전건강위험보고서: Genetic Health Risk Report FDA Roundup: September 1, 2023 | FDA FDA Roundup: September 1, 2023 The U.S. Food and Drug Administration is providing an..

FDA에서 AR (Augmented Reality)와 VR (Virtual Reality) 기술을 이용한 의료기기에 대한 고려 (또는 질문)사항을 정리 환자, 의료 관계자를 나누어 이점과 위험과 관련된 정보를 제공 Augmented Reality and Virtual Reality Medical Devices: Questions to Consider | FDA Augmented Reality and Virtual Reality Devices: Questions to Consider Medical extended reality (XR) has the potential to improve your health care. XR devices deliver new types of treatments and to..