Jeffrey Shuren, M.D., J.D., Director

FDA’s Center for Devices and Radiological Health

MassMEDIC FDA Update Conference

Dec. 1, 2010

In August 2010, FDA’s Center for Devices and Radiological Health, or CDRH, released for public comment the preliminary reports from the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. These committees were established in September 2009 to address critical challenges facing the Center and our external constituencies. In recent years, concerns have been raised by all constituencies about how well the current 510(k) program was meeting its two public health goals of facilitating medical device innovation and assuring that medical devices are safe and effective. In particular, industry had raised concerns that the 510(k) program had become less predictable, consistent and transparent thereby stifling innovation and sending companies and jobs overseas, and that CDRH reviewers had become less responsive and more risk averse. Consumer, third-party payers, and some health care professional groups were concerned that, for some devices, the 510(k) program did not provide adequate assurances of safety and effectiveness nor did it provide sufficient information for health care providers and patients to make well-informed treatment or diagnostic decisions. CDRH employees expressed concerns that the current 510(k) program failed to adapt to the increasing complexity of devices, and that reviewers’ ability to make well-informed decisions was undermined by the poor quality of 510(k) submissions. In addition, an increasing workload was straining an already overburdened program.

The 510(k) Working Group was charged with evaluating how well the 510(k) program was meeting its two public health goals and exploring actions CDRH should take to strengthen it. In addition, the Institute of Medicine, or IOM, is conducting an independent evaluation of the 510(k) program, and is expected to issue its report in mid-2011. The Task Force on the Utilization of Science was charged with making recommendations on how the Center can quickly incorporate new science — including evolving information, novel technologies, and new scientific methods — into its decision making in as predictable a manner as is practical. The Task Force and Working Group made a total of fifty-five recommendations addressing improvements to the 510(k) program and CDRH’s use of new science.

We have solicited and received a range of perspectives in developing the reports and on the recommendations contained in these reports at two public meetings and three town hall meetings, through three open public dockets and many meetings with stakeholders over the past several months. While there has not always been agreement on the best approaches for CDRH to take moving forward, there is widespread recognition that there is significant room for improvement. Seventy-six comments were submitted from medical device companies, representatives of the medical device industry, venture capitalists, healthcare professional organizations, third-party payers, patient and consumer advocacy groups, foreign regulatory bodies, trial lawyers, and others.

We have carefully analyzed and considered the comments received on all of the recommendations. The comments reflected support, in some cases with a caveat or suggested modification, for the majority of the recommendations contained in both reports, especially those related to enhanced guidance and standard operating procedures, greater transparency and clarification of review requirements, and increased training for Center staff and industry. Some recommendations received comments reflecting concerns from the majority of the constituencies represented.

In the coming weeks we plan to issue a summary of the comments we received and our response to them as well as a chart of our implementation plan that provides: i) a list of the recommendations we intend to implement or begin to implement in 2011; ii) the projected timeline for completing implementation of certain recommendations in 2011; iii) the achievement of major implementation milestones in 2011 for other recommendations; and iv) our plan to defer a final decision on selected recommendations pending feedback from the IOM. For those recommendations that we are referring to the IOM, we will delay a final decision on implementation to give the IOM Committee an opportunity to provide feedback should they decide to address these recommendations in their report or through another communication.

In the coming year we will focus our efforts on making significant progress to implement those actions that will have the greatest impact on fostering medical device innovation, enhancing regulatory predictability, and improving patient safety.

Our mission is to both protect and promote the public health. Critical to our success is to benefit patients by facilitating medical device innovation. However, we recognize that we have not been doing all we can do to help bring breakthrough devices to patients. The 510(k) and Science Reports clearly show that there is room for improvement on the part of CDRH. Our intent behind these reports is to provide a blueprint for a smarter medical device program with the tools CDRH needs to drive innovation and bring important technologies to patients quickly.

We are committed to meet these shared objectives through an interactive premarket review process that is predictable, consistent, transparent, and timely.

We want safe and effective devices on the market and we want patients to have timely access to them because we are doctors, nurses and other healthcare professionals, and we, our friends, and our families are also patients.

For the past several months we have been engaged in a continuous dialogue. While this dialogue needs to be ongoing, and we will keep up our end of the bargain through meetings such as today’s and additional town hall meetings next year, it is time to move forward and take targeted and measured steps that will best serve all of us, particularly patients. In that spirit I yield the floor back to you to discuss what you want to talk about.