Wednesday, October 6, 2010

FDA & Health Innovation

How wireless consumer electronics are affecting the delivery of healthcare and the role that FDA will play to regulate health innovation was a key topic at the ATA 2010 Mid-Year Meeting held September 26-28 in Baltimore.

Today’s wireless technology involving smart phones and home devices, EHRs, and information exchanges are emerging as critical tools to deliver medical services. To deal with the issues, FDA is reviewing their policies along with their regulatory responsibilities.

Bakul Patel, Policy Advisor for FDA’s Center for Devices and Radiological Health (CDRH) emphasized how important it is to keep unsafe and ineffective new technologies out of the marketplace but on the other hand, we need to use a balanced approach and find smarter ways to regulate.

According to Patel, the CDRH is re-examining the most commonly used premarket review pathway for devices entering the market. Specifically, this is known as the premarket notification 510(k) medical device review program. However, some are questioning whether the program can meet its goals.

The 510(k) Working Group has been charged with evaluating the program and is exploring actions that CDRH could take to improve 510(k) decision-making. Presently CDRH has plans to issue preliminary findings and recommendations for public comments on the process in the coming weeks.

Patel reports that CDRH is taking major steps to collaborate with others in the federal government. The Council on Medical Device Innovation composed of NIH, CMS, CDC, AHRQ, DOD, DARPA and VA is looking at unmet public health needs, identifying regulatory inefficiencies, and looking at what the federal partners can do to foster innovations and yet appropriately regulate the technology. Also, FDA recently signed an information-sharing Memorandum of Understanding with CMS will enable the two agencies to better coordinate their work.

FDA is also collaborating with universities on projects involving innovation. On October 26, 2010, FDA will host a workshop “Innovation, Technology Transfer, and Scientific Interchange: Leveraging Academic and FDA Collaborations to Resolve Unmet Public Health Needs” will be held in Silver Spring Maryland. This is the first Medical Devices Technology Innovation Partnership Project and is co-sponsored by the University of Virginia, Howard University, Johns Hopkins University, University of Maryland both at College Park and Baltimore, and the University of Pennsylvania. For more information, email Sophia Smith at

In August, CDRH released two preliminary reports on how to provide for smarter medical device oversight. The reports were developed by two internal groups, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. These groups made recommendations on steps to take to balance the public health approach, foster medical device innovation, enhance regulatory predictability, and improve patient safety.

Jeffrey Shuren, M.D., J.D, Director for CDRH highlighted in his August “Message as Center Director, ten recommendations contained in the reports:

• Streamline the premarket pathway for lower-risk novel devices
• Enhance science-based professional development for CDRH staff
• Establish a network of external experts to better inform the review of cutting-edge technologies
• Increase the predictability of 510(k) data needs by establishing a new “class llb”
• Create a new “Notice to Industry” tool to more rapidly communicate changes in premarket expectations
• Clarify the meaning of key terms in the 510(k) “substantial equivalence” review standard to improve the consistency, transparency, and timeliness of the review process
• Establish a Center Science Council as a new governance model to assure quality and consistency in CDRH’s science-based decision making
• Require the up-front submission of more complete safety and effectiveness information to support the review of 510(k) devices
• Create a searchable online public database to provide more detailed, up-to-date medical device information to industry, the healthcare community, and patients
• Clarify CDRH’s 510(k) rescission authority and the circumstances under which a device should not be used as a predicate

To download information on the reports, go to