CDRH Accelerates Software Development To Improve Collaboration With Industry
This article was originally published in The Gray Sheet
FDA’s device center hopes the effort, which is intended to model a quicker-turnaround “Silicon Valley” approach to system development, will help reduce time-to-market for new devices, and simplify some post-market surveillance efforts.
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FDA’s device center launched the second round of its entrepreneurs-in-residence program, bringing in outside experts to the center to focus on streamlining data collection and the approval-to-reimbursement pathway.
A proposed FDA regulation for a Unique Device Identification System is critical to the future of post-market safety surveillance, the agency says. The UDI system aims to reduce medical errors, and provide an array of other benefits for supply chain management. Makers of high-risk class III products will have one year to place UDI codes on devices. The UDI mandate will extend to moderate-risk class II devices two years later and to some low-risk class I devices two years after that.
Participants expect the program to tangibly reduce time to market and improve companies’ prospects for raising money.