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In its August 22 webinar, the U.S. Food and Drug Administration (FDA) discussed the Stage 1 requirements imposed on laboratory-developed test (LDT) manufacturers.U.S. FDA Final Rule on LDTsLDTs are in vitro diagnostic devices (IVDs) that are designed, manufactured and used within a single clinical laboratory and were placed under enforcement discretion in 1976 with the medical device amendments ..

Background - EURL designation 2023 In July 2022, the European Commission launched a call for the designation of EU reference laboratories in 8 categories of class D devices. Applicant laboratories had six months to prepare and submit applications to their Member State. The Commission reviewed the applications based on the following elements specified in the call: the applicant laboratories must ..

In Vitro Diagnostic (IVD) devices are a critical component of healthcare, as they help users diagnose conditions and formulate an appropriate treatment plan for a patient. In some cases, they may also be used for care management for certain diseases. In the U.S., IVDs are regulated like other medical devices and divided into one of three classes, each with its own general expectations for a spec..

On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs). These EURLs will be involved in conformity assessment of high-risk (class D) IVDs as well as carry out certain advisory tasks. The designated EURLs together cover the following categories of class D IVDs: Hepatitis and..