JD Consulting Blog
Updates from Jack Dhuwalia
FDA Town Hall Meeting in San Francisco, September 2011
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.
510(k) Regulations. Is there room for improvement? Sure...But Don’t Throw the Baby Out With the Bath Water
The 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.
Effective Design Control
JD Consulting helped to develop a design control system that not only helped the client with their product development process, but also passed FDA inspection.
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