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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
User is currently offline
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.

FDA Town Hall Meeting in San Francisco, September 2011

by Jack Dhuwalia
Jack Dhuwalia
Jack is an expert trouble-shooter specializing in the medical industry. He has b
User is currently offline
on Tuesday, 16 August 2011
510(k) Regulation 2 Comments

Jack is working on preparing for the next town hall meeting in San Francisco in September with Dr. Shuren and other FDA people. Any comments or input for this meeting would be appreciated. Just add to this post, or send an email to This e-mail address is being protected from spambots. You need JavaScript enabled to view it.

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