CDRH Focusing On New PMA Pathway, Clinical Trials Program In 2014/2015 Priorities
This article was originally published in The Pink Sheet Daily
CDRH Director Jeffrey Shuren discussed the device center’s two-year strategic priorities with “The Gray Sheet.” The center plans to rebalance pre-market and post-market data collection, when appropriate, and improve the processes for starting up clinical trials in the U.S.
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In an interview, CDRH Director Jeffrey Shuren detailed plans for new guidance documents and process changes at the device center focused on IDE reviews, clinical testing requirements and pre-submission interactions with payers based on recommendations from the center’s entrepreneurs-in-residence program.
Variability runs high in FDA’s process for approving new device trials, but the agency is open to recommendations for improvements coming out of its entrepreneurs-in-residence program, says Chip Hance, a former Abbott executive participating in the program.
Topics include anticipated guidance efforts, as well as emphasis on the work of the center’s nascent entrepreneurs-in-residence program.