February 2011

A Polsinelli Shughart Update

CDRH Innovation Initiative Aims To Improve Medical Device Review Procedures

On February 8, 2011, FDA’s Center for Devices and Radiological Health (CDRH) announced its “Innovation Pathway” effort and released a white paper entitled “CDRH Innovation Initiative.” The Initiative is, in part, a response to external criticism that CDRH has been clogging the medical device pipeline. It is also, in part, the result of a multi-year, internal review at CDRH to improve its medical device reviewing procedures. Industry actors, watchdog groups and members of Congress have all been waiting to see how CDRH is planning to address their various safety and efficiency concerns. The “CDRH Innovation Initiative” offers a glimpse of the agency’s thinking. Its stated purpose is to lay a foundation for a number of actions which will “encourage innovation, streamline regulatory and scientific device evaluation, and expedite the delivery of novel, important, safe and effective innovative medical devices to patients.”

Innovation Pathway Overview

CDRH proposes a number of actions to help speed innovative devices to market:

1. Establish a priority review program for innovative products
2. Establish a voluntary program to certify medical device testing centers
3. Develop an educational curriculum and new science to promote development and review of medical devices
4. Expand efforts to predict device trends so that CDRH will be prepared
5. Develop and utilize a network of experts for consultation on a case-by-case basis
6. Inaugurate the “Center Science Council,” a new group to oversee devices on the “innovation pathway”
7. Streamline the existing de novo pathway

What Does This Mean?

Regulatory uncertainty is one of the most significant barriers when a company seeks to introduce a medical device into the market. It affects everything, including the ability to obtain start-up financing, product design and marketability. CDRH’s Innovation Initiative could either represent a real advance in assisting innovator companies or – in the absence of adequate resources or proper development – offer no real improvement. Device companies should seek to ensure this new program makes appropriate policy and resource allocation choices and stay up-to-date on new developments.

What You Should Do Now

The Agency is seeking public input on the innovation pathway. Individuals and companies may submit comments to FDA’s public docket. In addition, CDRH will be holding a public workshop on March 15, 2011 at its headquarters on the White Oak campus in Maryland. CDRH is interested in comments regarding eligibility criteria, suitable technologies, reviewing deadlines, clinical test center certification and any additional actions. Device company representatives should consider submitting comments or attending the public workshop in order to better understand the implications.

For More Information

If you have questions about the CDRH Initiative or need additional information, please contact:

• Jason W. Sapsin at 720.931.1175 or jsapsin@polsinelli.com

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