US regulators recommend “codevelopment” approach for IVD companion Dx products

By Stewart Eisenhart, Emergo Group The US Food and Drug Administration is recommending steps for both manufacturers and its own staff regarding contemporaneous market authorization for therapeutic products and IVD companion diagnostics. In new draft guidance, the agency notes that “codevelopment” of therapeutic products along with IVD companion diagnostics is necessary to “facilitate innovation in precision medicine;” codevelopment as the FDA defines the term encompasses principles for product development, market authorization as well as clinical trial planning. Typically, a therapeutic product that requires an IVD device to perform safely and effectively will not receive premarket authorization if that IVD either hasn’t already obtained FDA clearance or approval, or if the IVD has not also been submitted for contemporaneous premarket review. General recommendations for codevelopment “Therapeutic products and IVDs typically are developed on different schedules, are subject to different regulatory requirements, and have different points of interaction with the appropriate review centers at FDA,” notes the guidance. “The merging of the two development processes to facilitate the contemporaneous marketing authorization of a therapeutic product and its corresponding IVD companion diagnostic requires that the sponsors of both products have a general understanding of both processes.” Given the substantially different premarket review pathways for therapeutic prod...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Blog Emergo Group Source Type: news