Shuren: CDRH Initiatives Underway
Posted: March 11, 2010
CDRH is not only taking actions related to the 2010 priorities announced earlier this year, but is also working towards a better understanding of standards. “Standards are an important part of the lifecycle of a device,” said Jeffrey Shuren, MD, CDRH’s new director, at AAMI’s 20th annual International Conference on Medical Device Standards and Regulation yesterday. Standards also help facilitate improvements in product design and raise the bar for safety and effectiveness. As part of Shuren’s effort to increase collaboration and provide more transparency, the new director announced that CDRH staff will be undergoing “rigorous” training to understand the use of standards as part of its 2010 strategy. 
 
A lack of predictability is the number one concern from industry, said Shuren, and standards increase predictability by providing specific performance points. Standards also remove guesswork and more clearly define expectations for what manufacturers must do upfront. With 834 standards currently recognized by CDRH (note: earlier in the day, Carol Herman cited this number as being close to or more than 900), 20% of staff engages in standards-related work as some part of their job. The growing number of standards recognition makes staff training even more critical for facilitating a healthy dialogue with industry. Shuren said that the training should help address inconsistencies in how CDRH staff handles standards.
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