2024年12月20日 · An overview of how the FDA regulates in vitro diagnostic products (IVD). Manufacturers can find detailed information about complying with the Federal, Food, Drug and Cosmetic Act (FD&C Act).

2024年11月13日 · In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be...

2025年1月21日 · A companion diagnostic device can be in vitro diagnostic (IVD) device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic...

2025年3月3日 · In vitro diagnostic (IVD) devices play a crucial role in modern healthcare by aiding in the detection, diagnosis, and management of a range of diseases. The U.S. Food and Drug Administration (USFDA) regulates these devices to ensure their safety and efficacy. IVD devices can be classified into two groups based on intended use, distribution, and regulatory oversight: IVD-Kit and IVD Non-Kit.

IVD tests include all clinical assays sold commercially as kits or devices that are used to analyze human specimens. IVD tests are therefore subject to FDA regulation, and sponsors must have premarket approval or clearance prior to marketing IVDs.

For purification of intracellular RNA from whole blood to be used for in vitro diagnostic (IVD) tests. Coupled with the PAXgene Blood RNA Tube, constitutes the FDA-cleared, CE-marked PAXgene Blood RNA System; Compliance with EU IVD Directive 98/79/EC; Efficient purification of high-quality intracelluar RNA; Standardized sample processing prior ...

Designed, validated, and regulated for clinical use, Illumina diagnostic (IVD) products include sequencing instruments, assays, library prep kits, and software. The first CE-marked IVD kitted solution for comprehensive genomic profiling (CGP) of DNA and RNA variants, plus MSI and TMB, for multiple solid tumor types.

2022年1月31日 · IVDs are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and may also be biological products subject to section 351 of the Public Health Service Act (PHS Act). Like other medical devices, IVDs are subject to premarket and postmarket controls.

Decision Summaries are attached to entries in FDA’s In Vitro Diagnostic Product Database. To find a Decision Summary for a particular product, This database search obtains information on all In...

2025年1月24日 · Key Understanding of US FDA IVD-Kit and IVD Non-Kit Device Process; Essential Framework for Compliance in Technical Documentation Under EU MDR 2017/745