Under pressure to finds ways to foster innovation, FDA launched the Innovation Pathway, a priority review program for new, breakthrough medical devices. The first submission to be reviewed is a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. FDA also announced plans to seek further public comment before the Pathway can be used more broadly.

Sharon Segal, vice president of technology and regulatory affairs for the AdvaMed, issued the following statement regarding FDA’s public meeting on the initiative in March. “AdvaMed appreciates FDA providing the opportunity for all stakeholders to offer input on its Innovation Initiative. We also commend the agency for its recognition that an efficient and predictable regulatory system is important for improved patient care and for America’s world-leading role in medical innovation.

“While we support 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. FDA has a number of tools already available to achieve these objectives and they should be used more broadly and effectively.”

The proposed Innovation Pathway program is part of a broader effort under way in FDA’s Center for Devices and Radiological Health (CDRH) designed to encourage cutting-edge technologies among medical device manufacturers. The initiative will also seek to strengthen the nation’s research infrastructure for developing breakthrough technologies and advancing quality regulatory science. Proposed actions include

• establishing a voluntary, third-party certification program for US medical device test centers designed to promote rapid improvements to new technologies during a product’s development and clinical testing stages;
• creating a publicly available core curriculum for medical device development and testing to train the next generation of innovators; and
• using more device experience and data collected outside the US.

In addition, CDRH intends to engage in formal horizon scanning–monitoring medical literature and scientific funding in a systematic way to predict where technology is heading. CDRH will include public input in this process to prepare for and respond to transformative innovative technologies and scientific breakthroughs.

“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,” said Segal.

“We support these initiatives and believe FDA should continue to focus on these process improvements to help address the unacceptable delays and inconsistencies that have plagued its review process in recent years and have needlessly delayed patient access to life-saving, life-enhancing medical technology.”

“Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions,” said CDRH Director Jeffrey Shuren, MD, JD. “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 has accepted its first submission from the Defense Advanced Research Projects Agency (DARPA) to review a brain-controlled, upper-extremity prosthetic designed to restore near-natural arm, hand, and finger function to patients suffering from spinal cord injury, stroke, or amputation. The arm system uses a microchip implanted on the surface of the brain to record neuronal activity and decode the signals to actuate motor neurons that control the prosthesis. DARPA and FDA have signed a Memorandum of Understanding addressing both the development and review of this project.

The proposed Innovation Pathway program is designed to review products that are truly pioneering technologies with the potential of revolutionizing patient care or health care delivery. Selected products would receive an Innovation Pathway memorandum from CDRH containing a proposed roadmap and timeline for device development, clinical assessment, and regulatory review. Products in the program would be assigned a case manager, and their important scientific issues would be identified and addressed earlier in the development process. They might be able to qualify for flexible clinical trial protocols.

Applications would be reviewed by the Center Science Council, a new oversight body currently being developed within CDRH comprised of senior managers and experienced scientists, who would facilitate this device development and evaluation process. According to FDA, enrollment in the program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and determine their appropriateness for marketing. Because of the transformative nature of the devices that would be eligible for this pathway, CDRH expects them to generally be approval pathways intended for either high-risk or novel products.

FDA could conduct premarket reviews of products in the program within 150 days, nearly half the time it currently takes the FDA to review most premarket approval applications. CDRH has set up a public docket to solicit public comment on the initiative.