FDA Innovation Pathway – Tech that Address Unmet Med. Needs

Below is a copy from the FDA webpage on Innovation Pathway.

Innovation Pathway

Background on CDRH Innovation

On Feb. 8, 2011, the FDA’s Center for Devices and Radiological Health launched its Innovation Initiative, which proposed actions the agency could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices in a way that maintains or improves patient safety and is based on sound science.

As part of that Initiative, the FDA proposed the Innovation Pathway, a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery. The FDA also announced a pilot submission — a brain-controlled, upper-extremity prosthetic — for review under the Pathway.

After considering public comments received on the Innovation Initiative — and extensive review of our experience from the pilot submission, the FDA is introducing the Innovation Challenge, a call for voluntary submission of innovative device applications for End-Stage Renal Disease (ESRD).

Regulatory decisions that improve patient access to safe and effective,  innovative medical devices

Developing a New Approach to Device Review
Background on CDRH Innovation

Bringing breakthrough, safe and effective medical devices to patients quickly, safely and efficiently improves lives and health care. To help reach patients with these devices as quickly as possible, the FDA created the Innovation Pathway — a priority program for technologies that address unmet medical needs in disease treatment, diagnosis and health care delivery.

The Innovation Pathway aims to shorten the overall time it takes for the development, assessment, and review of breakthrough medical devices. Some key areas of focus include the development of new decision tools to help the FDA assess and characterize benefits and risks to patients, and new collaborative ways for the FDA and innovators to share ideas about new device concepts. Where applicable, these new approaches, practices, and tools will be used in other pre-market programs.

Developing a New Approach to Device Review

Developing the Innovation Pathway is an evolving process that entails the FDA approaching medical device review using new paradigms — rapidly testing them, applying what works and learning from what doesn’t. A team of experts are analyzing each step of the premarket pathways for medical devices and exploring ways to bring about more patient-centric, predictable and swifter decisions that can also address the unique scientific challenges that innovative technology often brings. The team has begun developing new tools and processes, including:

A decision-framing tool to help reviewers and sponsors quickly determine product classification and regulatory direction;
A decision-framing tool to help reviewers and sponsors determine requirements for first-in-human clinical trials; and
A collaborative workspace where FDA staff, medical device developers, patients, scientists and industry can discuss the technology, intended use and the unmet public health need.

These tools, and others in development, present the FDA with the opportunity to commit its time and resources much earlier in product development. By front-loading these resources, the FDA can identify and resolve new scientific and regulatory challenges that may accompany an emerging technology that raises new or novel scientific questions. As a result, patients will receive safe and effective products more quickly and device makers can bring important technologies to market more predictably, faster, and at a lower cost.

In order to use and evaluate the new tools and processes, the FDA is inviting innovators who have ideas for medical devices that diagnose or treat End-Stage Renal Disease (ESRD) to volunteer for our Innovation Challenge. When proven successful, the FDA plans to integrate these new approaches into its other premarket programs when applicable.

Additional Information

FDA Innovation Pathway – Tech that Address Unmet Med. Needs