- SPECIAL REPORTS
“At best, the recalls have led to temporary fixes without addressing the systemic and underlying concerns,” he says. “Recalls produced patches on top of patches.”
To speed the development of safer, more effective infusion pumps and other devices, the CDRH has launched the Medical Device Innovation Initiative. Introduced in February, the initiative aims to facilitate the development and evaluation of new medical devices; strengthen the nation’s research infrastructure; and respond quickly to scientific breakthroughs.
To achieve these goals, the CDRH plans to:
• establish an Innovation Pathway, a priority review program for pioneering medical devices.
• establish a voluntary, third-party certification program for U.S. medical device test centers.
• create a publicly available core curriculum for medical device development and testing.
• include data collected outside the United States when reviewing new medical devices.
• monitor medical literature and scientific funding in a systematic way to predict where technology is heading.
• develop a network of experts to assist in addressing scientific questions about emerging technologies.
To qualify for expedited review under the Innovation Pathway, a device must meet at least one of the following criteria:
• significantly improve upon currently available treatments or diagnostic methods.
• treat or diagnose a life-threatening or irreversibly debilitating disease or condition.
• address an unmet public health need.
• address an issue relevant to national security.
If a product is accepted for review under the pathway, the CDRH would provide the manufacturer with a proposed roadmap and time line for device development, clinical assessment and regulatory review. The product would be assigned a case manager, and important scientific issues would be identified and addressed earlier in the development process. The device could also qualify for flexible clinical trial protocols.
Applications would be reviewed by the Center Science Council, a new oversight body being developed within CDRH comprised of senior managers and experienced scientists. Enrollment in the Innovation Pathway program would not change the scientific or regulatory standards that CDRH would use to evaluate device submissions and determine their appropriateness for marketing.
Once the device completes preclinical and clinical stages of development, it would be submitted for regulatory review. Reviewers would have 150 days to complete their review, nearly half the time it currently takes the FDA to review most premarket approval applications.
The first device that will be evaluated under the new pathway is 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. Funded by the Defense Advanced Research Projects Agency, 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.
For more information, visit www.fda.gov/deviceinnovation.