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510(k) Regulations. Is there room for improvement? Sure...But Don’t Throw the Baby Out With the Bath Water

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
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on Friday, 08 February 2013
Regulatory Compliance 2 Comments

510k_productsThe recent Institute of Medicine (I of M) report brings an old idiom to life: “Don’t throw the Baby out with the Bath Water!” According to the IOM, “...The current process is untenable.”  I applaud that Dr. Jeff Shuren, Director, CDRH, FDA, has announced his support for the current 510(k) regulations to demonstrate “substantial equivalence” to a device on the market.

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