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▶ Introduction The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related to an equivalent device in the clinical evaluation required for a device under conformity assessment. Whilst carrying out a clinical investigation is the most direct way to generate clinical data concerning the safety an..

▶ Introduction The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical purpose that are listed in Annex XVI as from the date of application of the Commission Implementing Regulation (EU) 2022/2346, hereinafter referred to as the common specifications (CS). Products without an intended medical purpose t..

유럽연합에서 소프트웨어와 결합할 수 있는 하드웨어 또는 하드웨어 구성요성에 따라 규제사항의 적용 및 조항에 대한 가이던스를 발표하였다 (MDCG 2023-4). [소프트웨어 (MDSW)와 결합 가능한 하드웨어 조건 리스트] 1. A회사에서 생체신호를 획득하는 HW 또는 HW components를 만들고, 이와 연동이 되는 SW도 제작하는 경우 2. A회사에서 생체신호를 획득하는 HW 또는 HW components를 만들고, B회사에서 HW 또는 HW components와 연동이 되는 SW를 제작하는 경우 3. A회사에서 스마트폰 또는 웨어러블 디바이스를 통한 생체신호를 측정하여 SW에 전달되는 경우 4. A회사에서 스마트폰 또는 웨어러블 디바이스에서 측정된 생체신호를, B회사의 SW (App)에 전달되는..

[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..

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..

▶ 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..

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, ..