In February 2011, the FDA's Center for Devices and Radiological Health (CDRH) proposed the Innovation Pathway, a priority review program designed to help safe, breakthrough medical devices reach patients in a timely manner by improving collaboration between FDA and medical device innovators. The Innovation Pathway was designed to:
- Shorten the time and reduce the costs from concept to commercialization for innovative medical devices.
- Transform how FDA does business with innovators and improve the Agency’s pre-market programs.
- Provide a vehicle to test new processes and decision and analytic tools.
- Solicit and accelerate innovation focused on high priority unmet health needs.
Enrollment in the Innovation Pathway program did not change the scientific or regulatory standards that CDRH uses to evaluate device submissions and determine their appropriateness for marketing. Instead, Innovation Pathway served as a living laboratory to test new tools and methods for breakthrough devices that we may also apply to other technologies to enhance all of our device pre-market programs.
The Innovation Pathway programs were guided by the following principles:
Principle #1: Shorten the Total Time to Market For Safe & Effective Medical Devices
The Innovation Pathway looks at the total amount of time it takes for a specific device to get on the U.S. market. Specifically, Innovation Pathway supports early and frequent collaboration between the innovators and FDA staff to reduce the time and cost of the entire device development process.
Principle #2: Transform the “User Experience”
The Innovation Pathway expands upon the methods of collaboration within FDA’s pre-submission processes to improve how FDA staff and innovators can work together as one team. By applying the guiding principles of the “Collaboration Phase Playbook” these earlier interactions also allow FDA the opportunity to better understand the technology and develop regulatory strategies, including incorporating the Benefit-Risk guidance and the assessment of patient perspectives during the earliest phases of the device development process.
Principle #3: Make Decisions that Facilitate Forward Progress
The Innovation Pathway is designed to provide a decision support process to assist the reviewers and innovators with clarity on how decisions are made, perhaps even discovering new parameters that will allow new data and safety and effectiveness information to emerge more quickly.
The Innovation Pathway recognized the unique nature of transformative innovative product development. By identifying appropriate clinical endpoints or outcomes and key scientific questions, CDRH can seek advice from external experts early in the device development process and provide a more timely and efficient regulatory review.
In 2011, the FDA accepted its first submission for the Innovation Pathway 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.
With help from our Entrepreneurs in Residence, the second version of Innovation Pathway, called “Innovation Pathway 2.0” (IP 2.0) launched in April 2012, with new and modified tools and methods. To test IP 2.0, CDRH selected three products from the Innovation Challenge: End-Stage Renal Disease, a pilot focused on developing innovative technology to improve the treatment of end-stage kidney disease. The sponsors of these products collaboratively discussed their technology with CDRH reviewers and worked with the Center on the development of a benefit-risk profile to help guide future studies and map out a regulatory path forward (a Data Development Plan) for their product. IP 2.0 also supported communications and interactions between the sponsors, FDA and the Centers for Medicare & Medicaid Services (CMS). The Innovation Challenge and IP 2.0 program successfully concluded in November 2014 with all three participating developers reporting that the program established an environment of trust that stimulated technical enhancements and significantly shortened their devices pathway to market.
Innovation Pathway piloted principles that could yield significant benefits to patients in the U.S. by giving them first-in-the-world access to medical devices by improving how FDA staff and innovators work together and ultimately shortening the overall time and cost it takes for the development, assessment and review of medical devices of public health importance.
In April 2014, the FDA proposed a new program – Expedited Access Pathway Program (EAP). EAP is a voluntary program within CDRH that builds on the Innovation Pathway and FDA’s experience with early and more interactive engagement between with device manufacturers. Through EAP, patients will have more timely access to these medical devices by expediting their development, assessment and review, while preserving FDA’s statutory standard for PMA approval (reasonable assurance of safety and effectiveness).
In addition to EAP, the FDA also published the guidance – Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval. This guidance clarifies FDA’s current policy on balancing premarket and postmarket data collection. Specifically, in some circumstances the FDA may consider it acceptable to collect certain data in the postmarket setting instead of in the premarket setting to improve patient access to safe and effective medical devices that are important to the public health.
Processes and tools from Innovation Pathway are also evident in the following guidance documents:
- Types of Communication During the Review of Medical Device Submissions
- The Pre-Submission Program and Meetings with Food and Drug Administration Staff
- Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies