Will Class IIb See The Light Of Day? FDA Sends Mixed Messages

Article preview from "The Gray Sheet"- September 26, 2011

It remains unclear how FDA will move forward with its most controversial 510(k) reform proposals, such as creating a separate class IIb category for more complex devices, with mixed messages from the agency on whether the proposals are still on the table.

Will Class IIb See The Light Of Day? FDA Sends Mixed Messages

Article preview from "The Gray Sheet"- September 26, 2011

During closed-door user fee negotiations Aug. 9, FDA assured industry representatives it has “no current plans” to implement the seven most controversial 510(k) reform recommendations it first proposed in its August 2010 preliminary 510(k) report and later punted to the Institute of Medicine for input.

“Industry asked FDA to comment on workload impacts of the seven items that FDA referred to IOM,” the meeting minutes, released last week, state. “FDA replied that there are no current plans to implement these recommendations.”

But publicly, FDA is indicating that the jury is still out on class IIb. The agency will announce its plans regarding that and the other controversial recommendations by the end of October.

“Regarding class IIb … we have not yet made an official decision,” an FDA spokeswoman told "The Gray Sheet" Sept. 22. “We intend to announce by the end of October what we plan to do regarding both the IOM's recommendations and those recommendations from our reports we had deferred a decision on to allow the IOM to weigh in on if they so chose.”

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