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By Allyson B. Mullen, Gail H. Javitt, and Philip Won | The FDA has issued a new proposed rule on laboratory-developed tests (LDTs), expressly defining LDTs as a type of in vitro diagnostic (IVD) device, and subject to device regulations, including registration and listing, premarket review, and more. The FDA is accepting comments on the proposed rule through December 4. |
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Risk Tool Selection With ICH Q9(R1) In Mind | By Amanda McFarland and Ryan Murray, ValSource, Inc. | This article focuses on the formality concept discussed in the revision of ICH Q9 Quality Risk Management released earlier in 2023. The authors provide a helpful overview of what risk tools are appropriate to use during certain types of scenarios, and what the team composition should look like. |
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| The Nuts And Bolts Of Brushless DC Motors | White Paper | Canon USA, Inc. Optoelectronic Components | An overview of BLDC motors, their basic components, how they operate, how they differ, and where they are used. |
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| Specialty LCP Compounds For Electronics Integration | White Paper | Celanese | In this article, Young Kim, Ph.D., senior principal engineer/chemist, Don DeMello, principal engineer field development, and Philip Wilson, Ph.D., marketing director medical, all of Celanese, discuss the benefits of recent advances in liquid crystal polymer for connected medical devices. |
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