The Future of Medical Devices
Earlier this year, FDA announced plans to increase consistency and clarity in the medical device review process—including our standards for safety and effectiveness—and encourage innovation within the medical device community. These reforms—which included 25 actions that CDRH, the Agency’s medical device center, will take in 2011 to improve the predictability, consistency, and transparency of its premarket review programs—are an important first step to encourage innovation and address some of the barriers that can impede a product’s timely progress to market while assuring that devices are both safe and effective. These actions were designed to increase the ability of innovating companies to attract investors, estimate costs, and bring safe and effective products to market more quickly.
Following continued discussions with the medical device community, FDA is moving forward with several new actions through the CDRH Medical Device Innovation Initiative to help accelerate and reduce the time and cost of development, assessment, and review of innovative medical devices. By establishing a new expedited review pathway, providing better training and incentives to staff, and offering increased clarity to industry, CDRH will reduce product review times and increase consistency in the review process.
New Expedited Review Program
Under the current framework at FDA, pioneering treatments and diagnostics are typically reviewed under the premarket authorization (PMA) pathway, which is often time-consuming and costly. To help prevent unnecessary delays, the Agency recently created a new, expedited review program called the Innovation Pathway that will provide a more streamlined path to market for important technologies. Under this program, CDRH will commit time and resources earlier in the product development process so scientific issues and regulatory hurdles can be identified early on and unnecessary delays can be avoided. Clinical trial protocols will be developed by the sponsor and CDRH through an interactive process and have flexibility built in to allow for repeat testing and redesign, which will reduce the cost and time of development and ensure an efficient review.
Understanding Emerging Technologies
The ability to effectively identify, anticipate, and respond to technological innovation and scientific breakthroughs is particularly challenging in the medical device realm because of the tendency of these devices to emerge and evolve rapidly. To increase FDA’s preparedness in this area, CDRH will identify emerging trends in science and technology by enhancing its current horizon scanning methodology, an approach that incorporates information from a broad range of sources, such as reviewing important scientific literature and accounting for public health needs, seeking input from manufacturers and other stakeholders, and considering technologies funded by other government agencies. In addition, CDRH, in an effort to enhance its scientific capabilities, is in the process of developing a Network of Experts to serve as a resource to address scientific questions and provide better understanding of emerging technologies in fields where FDA reviewers may not be immediately familiar.
FDA’s Center for Devices and Radiological Health is participating in a pilot agency program sponsored by the White House Office of Science and Technology Policy that brings innovation experts into federal agencies to collaborate on improving business models that will empower positive change, including economic growth, job creation, and leadership in innovation technology. The EIR program allows CDRH to engage with more than a dozen outside experts who bring state-of-the art thinking in business process and medical device innovation, decision science, and information technology. Five of these entrepreneurial experts will work alongside staff and management to build an early working version of the Innovation Pathway program, a priority premarket review program whose principal focus is on technologies that demonstrate the potential to revolutionize disease treatment, diagnosis, or health care delivery and that target unmet medical needs.
Increasing Consistency through Improved Training
To help increase consistency between review teams for medical devices, all new reviewers are now required to participate in a Reviewer Certification Program. This program will provide new staff with training on the fundamental review principles and practices that are essential at CDRH.
The Agency is also developing an Experiential Learning Program that will provide staff with real-world training experiences as they visit manufacturers, research and health care facilities, and academic institutions. This will allow staff to see devices while they are being manufactured, as well as during actual clinical use. This comprehensive understanding of the device technology and use will inform the review process in a meaningful way.
Providing Additional Clarity to Industry
Companies often rely on FDA’s written guidances to clarify key elements of the medical device development pathway and ensure they are providing FDA with the necessary information to determine a product’s safety and effectiveness. CDRH is developing a series of additional guidances to address important questions by industry in certain areas. These include: a guidance to streamline the de novo process (released on September 30, 2011), which can facilitate the development and review of innovative, lower-risk devices; a guidance on first-in-human studies that will describe the circumstances under which such studies can occur earlier in the development pathway and allow for iterative changes to the device without having to apply for a new Investigational Device Exemption; a guidance on criteria for approving and not approving clinical trials, including feasibility studies and pivotal trials; and a guidance (released on August 15, 2011) on the factors used in making benefit-risk determinations for device approval and clearance.