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BackgroundMedical device manufacturers must conduct appropriate testing to demonstrate that their devices are appropriately safe and effective before sale in the US. In many cases some animal and/or microorganism testing, such as to demonstrate biocompatibility, is required to obtain U.S market authorization.In February 2024, the U.S. Food and Drug Administration (FDA) noted concern that some th..

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 ..

Emergo에서 아래와 같이 웨비나를 개최한다. ▶ 주제: In-house tests under EU IVDR - How to best meet your IVDR deadlines ▶ 일시: 2024년 02월 28일 CST 9시 (한국시간: 02월 29일 자정) The In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 is not only affecting legal manufacturers (companies) but also clinical laboratories using in-house tests. Though not all requirements apply to clinical laboratories, they must ma..