Recently, the Food and Drug Administration (FDA) announced the “Medical Device Innovation Initiative,” which proposes actions that the Center for Devices and Radiological Health (CDRH) could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices safely and based on sound science. These actions include:
- Facilitate the development and regulatory evaluation of innovative medical devices;
- Strengthen the U.S. research infrastructure and promote high-quality regulatory science; and
- Prepare for and respond to transformative innovative technologies and scientific breakthroughs.
Much of the emphasis on medical devices comes as the FDA recently overhauled its recommendations and policies regarding the 510(k) approval pathway.
Consequently, FDA last week held a public meeting on the “Innovation Initiative” to solicit public feedback on select actions. Specifically, FDA sought input on a number of identified challenges associated with incentivizing innovation, and the proposed solutions. In addition, the agency requested comments on the Innovation Pathway proposed under the initiative.
According to an article from MassDevice, FDA kicked off the program by choosing a robotic arm being developed by the military as its pilot candidate, granting priority review to a Defense Advanced Research Projects Agency project to create a “brain-controlled, upper-extremity prosthetic.” The DARPA team is looking to “restore near-natural arm, hand and finger function to patients suffering from spinal cord injury, stroke or amputation,” according to the FDA.
The article noted how the “new regulatory pathway, which is slated to undergo public review before more projects are selected, is the CDRH’s push to boost the development of “pioneering medical devices” that’s “designed to encourage cutting-edge technologies among medical device manufacturers.”
CDRH Director Jeffrey Shuren noted that, “Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions.” As a result, he asserted that “CDRH’s Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs.”
FDA also noted that on April 7, 2011, it will convene a workshop in Silver Spring, Maryland, on how to create a database of medical device labeling and pictures without revealing any device makers’ proprietary information. The aim is a repository of data for the public, researchers, and the medical device industry. It was noted that there “might also be a photo of the device and any acceptable accessories.” FDA also anticipated that the repository would not include service and technical manuals, nor would it supply any proprietary information.
In response to FDA’s new Innovation Initiative and public meeting, Sharon Segal, vice president of technology and regulatory affairs for the Advanced Medical Technology Association (AdvaMed), issued a statement commending FDA for giving all stakeholders the opportunity to offer input.
Ms Segal noted that while AdvaMed “supports the goals of the Innovation Initiative, we believe that early and consistent interaction and the focus on a cooperative effort to get safe and effective products developed and reviewed quickly should be available to all innovative products, especially those that currently qualify for expedited review.” Accordingly, she noted that “FDA has a number of tools already available to achieve these objectives and they should be used more broadly and effectively.”
In addition, the statement noted how “FDA already has identified several steps it intends to take to bring greater speed and consistency to the current review process, including greater reviewer training, development of more guidance documents, and streamlining the de novo process.” AdvaMed stated that it “supports these initiatives and believes FDA should continue to focus on these process improvements to help address the unacceptable delays and inconsistencies which have plagued its review process in recent years and have needlessly delayed patient access to life-saving, life-enhancing medical technology.”