Article preview from "The Gray Sheet"- February 27, 2012
The device center is dropping seven controversial 510(k) reform-related proposals, including creating a “class IIb” category of devices, following pushback from industry. But some of the matters are under consideration on Capitol Hill.
Article preview from "The Gray Sheet"- February 27, 2012
CDRH will not independently move forward with any of the seven controversial 510(k) reform recommendations that were sent to the Institute of Medicine for consideration last year, Center Director Jeffrey Shuren said in an interview. But some have reemerged in Congress, he added.
The seven proposals, including creating a new “class IIb” category of moderate-risk devices and developing guidance detailing when a device should no longer be used as a 510(k) predicate, were among the recommendations
raised by CDRH’s 510(k) working group in 2010. But after strong criticism from industry, FDA decided to refer the proposals to the IOM committee reviewing the 510(k) program.
When IOM failed to address the proposals in its August 2011 report, their status became ambiguous.
Now Shuren confirms that they are off the table at CDRH, unless Congress says differently.
Continued...
To read this article in its entirety, Purchase now as a PDF and receive it immediately via email. Or get it FREE when you subscribe to Medtech Insight Newsletter.
About Medtech Insight
Medtech Insight newsletter provides insights into the technology and market developments (devices, instrumentation, biomaterials, gene therapy, tissue engineering, etc.) impacting a wide range of surgical and non-surgical clinical practices.
Plus:
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512
Comments