Sunday, October 2, 2011

Secretary Speaks at AdvaMed2011

The need to sustain U.S leadership in medical technology was voiced at the “AdvaMed2011: The MedTech Conference” held September 26-28 in Washington D.C. “For decades, the medical device industry has been a shining example of American innovation and creativity” said Kathleen Sebelius, HHS Secretary speaking at the conference luncheon on September 28th.

She praised the development of medical products from coronary stents to dialysis technology to cutting edge imaging. Other technology recently cleared by FDA, includes the first test to diagnose the early stages of Q fever, an emerging infectious disease among U.S. soldiers serving in Iraq and worldwide and the first ever mammography device to provide 3D images for breast cancer screening and diagnostic purposes.

The Secretary pointed out that the medical device sector is one of the few areas of the American economy that consistently runs a trade surplus and exports are expected to continue to grow. The Department of Commerce projects that the growth of exports will continue to grow at an annual rate of 5 to 10 percent.

Secretary Sebelius discussed FDA’s plans for the future. The government needs to work with the medical device industry to ensure the timely approval of safe and effective medical devices. To does this, the agency must continue to streamline and modernize FDA processes and procedures and make device approval and clearance not just scientifically rigorous but also clear, consistent, and predictable.

As announced, FDA is creating a network of external experts to help resolve complex scientific issues related to the development of medical devices and to improve the business process for information technology. The agency plans to establish an “Innovation Pathway” to streamline the regulatory pathway for breakthrough medical devices

FDA is also working with Medicare and Medicaid to establish a process for doing premarket evaluations and reduce the time and uncertainty surrounding coverage decisions for these programs.

According to the Secretary, steps taken by FDA in 2011 so far include:

• In January 2011 FDA announced 25 steps the agency will take in 2011 to improve the predictability, consistency, and transparency in their programs

• FDA has established an internal Center Science Council to actively monitor quality and performance in the agency

• FDA has published a series of draft guidances for both industry and staff to help address confusion and uncertainty about key parts of the premarket review, clinical trial programs, and how the agency should make benefit-risk determinations

• FDA has launched a new training program for new reviewers

To specifically address mobile medicine applications, Bakul Patel, Policy Advisor on mHealth and Medical Devices for the Center for Devices and Radiological Health at FDA took part in an AdvaMed panel on wireless health.

The recent FDA public workshop on September 12-12, 2011 was held to listen to comments on mobile medicine applications. With the FDA Guidance document on Mobile Medicine Applications released July 2011, FDA is examining what their regulatory authority should be concerning software applications for use on mobile platforms.

As Patel explained, FDA held the workshop to hear various approaches on not only mobile medical applications but also to discuss the issue of accessories related to mobile medical applications. The FDA also has to give consideration to Clinical Decision Support (CDS) in terms of defining stand-alone CDS software.

For more information on the AdvaMed2011 Conference, go to