March 2011

A Polsinelli Shughart Update

510(k) Reform

On January 19, 2011, FDA’s Center for Devices and Radiological Health (CDRH) identified 25 actions it would take regarding the 510(k) process to foster medical device innovation while maintaining the safety and effectiveness of medical technologies. These represent the distillation of more than 50 action steps recommended through the agency’s internal review process. FDA uses 510(k) premarket notification reviews to clear approximately 3,000 medical devices each year.

CDRH Director Dr. Jeffrey Shuren has acknowledged industry criticism that the program is “unpredictable, inconsistent and opaque,” and FDA's own internal concerns that the 510(k) program has not evolved sufficiently to deal with “the increasingly complex devices under review.”

Main Points

The 25 steps identified by CDRH can be described as falling into three, broad categories – communication, process improvement and oversight/auditing.

1. Communication - The Center intends to promulgate eight sets of new draft guidance by the end of 2011, covering subjects including device modifications; clinical trials; de novo classifications; appeals; and pre-submission interactions between industry and the agency. Additionally, CDRH will also hold public meetings and expand the use of “Notice to Industry Letters.”
2. Process Improvement - Evaluate and, as necessary, adjust CDRH staffing models; enhance training within the Center and for industry; develop a network of external experts; and improve “knowledge management” within CDRH.
3. Oversight/Auditing - CDRH intends to form a “Center Science Council” to help the Center respond to new scientific information, audit 510k decisions and advise on clinical trials; improve the collection and analysis of post-market information; and audit and reform the IDE process.

What Does This Mean?

The 510(k) process has become increasingly burdensome, slow and unpredictable, resulting in the erection of a substantial barrier to entry into the medical device market. CDRH’s proposals, therefore, constitute an important, highly public recognition of the difficulties encountered by companies as they travel the 510(k) pathway. 2011 promises to be an extremely challenging year for medical device companies as the agency attempts simultaneously to keep pace with incoming 510(k) notifications while proposing and implementing process reforms and new policies.

What You Should Do Now

Active industry engagement with the agency will be critical throughout 2011 in order to help shape a meaningful course of 510(k) reform. New draft guidance documents will begin to be posted in June and continue through the remainder of the year. These should be carefully reviewed and, as appropriate, commented on. Companies should consider ways of participating in the public meetings, which will be used to evaluate some of the more controversial 510(k) improvements which have not yet been formally adopted by the agency. Finally, companies should be aware of both the potentially disruptive and positive effects of CDRH’s 510(k) improvements to existing and planned 510(k) submissions.

For More Information

If you have questions about 510(k) Reform or need additional information, please contact:

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

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