Changing The Paradigm: 510(k) Draft Guidance May Raise New Questions

Article preview from "The Gray Sheet"- January 9, 2012

New concepts such as “primary predicates” and “reference devices” may be more confusing than clarifying, former FDA staffers say.

Changing The Paradigm: 510(k) Draft Guidance May Raise New Questions

Article preview from "The Gray Sheet"- January 9, 2012

Device industry watchers say FDA’s new overarching draft guidance on the 510(k) pre-market review program introduces new concepts that may add confusion, not clarity, to device makers planning to bring new products to market.

FDA issued the hotly anticipated draft guidance on Dec. 27, 2011. Once finalized, it will replace aging documents that have long defined the 510(k) pathway, by which most devices reach the U.S. market.

According to FDA, the new document, titled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” was informed by the top-to-bottom assessment of the 510(k) program that the agency began in 2009.

The draft addresses many of the key topics that have sparked debate during the 510(k) reform process, including when clinical data might be needed in 510(k) submissions, how a device’s “indications for use” relate to potential changes in its “intended use” and how to rely on multiple predicates. It also puts new emphasis on ensuring that “510(k) Summaries” submitted with the pre-market notification applications are accurate and up to date.

 

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