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[Emergo, UL] FDA Expands Unannounced Inspections at Foreign Manufacturing Plants Beyond India and China Pilot

The U.S. Food and Drug Administration (FDA) has announced (May 6) that the Office of Inspections and Investigations (OII) will expand its program (pilot) of unannounced inspections beyond India and China. As we reported earlier this year, the FDA has the authority to perform both announced and unannounced inspections. In general, inspections of relevant entities in the U.S. have been unannounced..

Including representative and intended users for a human factors (HF) validation test provides invaluable data for manufacturers because participants’ performance data can demonstrate a product’s expected safety and effectiveness once it is in the market. However, it can also be extremely difficult, or nearly impossible, to recruit exact users for a particular product due to the rarity of a condi..

The U.S. Food and Drug Administration (FDA) has opened the test submission phase of the new Electronic Submission Gateway NextGen system (ESG NextGen) in preparation for the official launch at 9:00 a.m. ET on April 14, 2025. The testing phase will conclude after April 11, and the existing (legacy ESG) system will be disabled at midnight Eastern time (ET) on April 12. No submissions can be made i..

(출처: 한국의료기기산업협회)G밸리의료기기개발지원센터와 지에스컨설팅에서 서울 및 G밸리 내 의료기기 제조업체, 초기 스타트업, 재직자를 대상으로 의료기기 기업대상 2025년 상반기 교육을 실시한다. ▶ 모집기간 : ~ 2025년 5월 3일까지▶ 교육일정 : 2025년 5월 8일(목)부터 6월 26일(목)까지 매주 목요일 14:00 ~ 17:00 ▶ 교육장소 : G밸리의료기기개발지원센터 서울 구로구 디지털로26길 111, JNK디지털타워 1층 (지하철 2호선 구로디지털단지역 2번 출구에서 도보 12분) ▶ 교육신청 : 의료기기 기업대상 2025년 상반기 교육 (바로가기) ..

The first three months of 2025 have ended and our team has been ardently sharing regulatory news. No particular regulatory update was heralded as groundbreaking (other than news of an agreement between the Malaysia Medical Device Authority (MDA) and China NMPA to ease regulatory requirements for certain classes of devices). Progress from the International Medical Device Regulators Forum (IMDRF) ..

Court decision on LDTsOn March 31, 2025, the US District Court (Eastern District of Texas, Sherman Division) ruled that the FDA’s Final Rule on Laboratory Developed Tests (LDTs) published in 2024, which phases out enforcement discretion and phases in standard medical device requirements, be vacated and set aside. This court determined that Congress has vested authority of test services to the Ce..

Addressing potential usability issues early in the human factors engineering (HFE) process can save your team time and money over the course of development while providing evidence of a robust human factors process to regulatory agencies. Cognitive walkthroughs are a powerful method to identify potential usability issues in early development stages when initial decisions about design directions ..

Importance of reviewing warning lettersBy reviewing relevant U.S. Food and Drug Administration (FDA) warning letters, manufacturers can better understand areas of frequent concern related to quality management systems (QMS) and regulatory affairs. This can allow companies to focus on areas of highest risk as they continually assess and improve their internal procedures and processes. It also hel..

(출처: 한국의료기기협동조합)고대의료원 임상연구자원실에서 FDA 의료기기 관련 AI 규제 가이드라인 초안 지침을 번역/요약하여 발표하였다. ▶ 주요내용기기설명사용자인터페이스 & 라벨링위험평가데이터관리검증 (Validation)기기 성능 모니터링 사이버보안Public Submission Summary  [고려대의료원] FDA, 의료기기 관련 AI 규제 가이드라인 초안 지침 발표 – 한국의료기기협동조합 [고려대의료원] FDA, 의료기기 관련 AI 규제 가이드라인 초안 지침 발표 medinet.or.kr

Background on eSTARThe electronic submission template and resource (eSTAR) template can be used to submit US FDA Premarket Notifications (510(k)s), De Novos, and Traditional Premarket Applications (PMAs). eSTAR was compulsory for 510(k) submissions starting in October 2023. eSTAR will be required for De Novos starting in October 2025.eSTAR version 5.5eSTAR Version 5.5 was released (February 12)...