FDA has launched a pilot program to help it develop the final guidance on qualifying medical device development tools (MDDT).

The Aug. 15 document, titled “Pilot Program for Qualification of Medical Device Development Tools,” builds on FDA’s Nov. 2013 draft guidance for plans to improve the device approval process by creating a system for FDA to formally qualify development tools for any company to use. Experience with the MDDT pilot program will help inform FDA’s final guidance on the MDDT qualification processes, FDA explains.

Experience with the pilot program will help inform FDA’s final document on the MDDT qualification processes.

The agency defines an MDDT as a scientifically validated method that aids in device development and regulatory evaluation. Examples include clinical outcome assessments such as patient-reported outcomes or clinical outcomes, biomarker tests or imaging methods, nonclinical “bench” or animal models. (See [A#01131118006].)

“This proposed voluntary qualification process is intended to enable submitters of MDDT proposals chosen for this pilot program to work closely with FDA to determine the amount and type of evidence and other information needed to support qualification for a specific tool and context of use,” FDA explains in the document.

FDA says it plans to prioritize proposals for the pilot based on public health need or the proposed tool’s potential to impact multiple device development programs. In reviewing proposals for the pilot, FDA will especially consider the feasibility and development timeline of the tool as well as its burden on FDA resources.

FDA expects that manufacturers will be more likely to rely on an MDDT that has already been accepted and qualified through this voluntary process than tools that FDA might not accept in a regulatory submission.

“The proposed MDDT qualification process supports the FDA’s plan to advance regulatory science--the science of developing new tools, methods and approaches to assess the safety, effectiveness, performance, and quality of medical devices,” the agency explains. “Advancements in regulatory science help to bridge the gap between research and discovery of medical devices and the actual delivery of the device to patients. The proposed qualification process also supports FDA’s strategic priority of strengthening the clinical trial enterprise by potentially increasing the efficiency of the clinical studies.”

Following release of the draft guidance in 2013, AdvaMed and other manufacturers told FDA that its proposed qualification program, as described, might struggle to attract submissions because developers would want to keep the intellectual property protection and compensation for the tools they develop before making them publicly available.(See [A#01140303014].)

FDA says it will keep proprietary information confidential and that the MDDT pilot program “places no requirements on licensing/cost/degree of access to intellectual property associated with a tool, nor does it consider restrictions related to patent claims.

In the pilot program document, FDA explains that it “intends to make public the context of use, summary of evidence, and basis of the qualification determination (analogous to summaries of approved devices)” and that submitters must agree to make the tools accessible to the public through sales, open source, etc. and cannot restrict them to certain private entities, such as a single manufacturer.

However, the agency also says it will keep proprietary information confidential and that the MDDT pilot program “places no requirements on licensing/cost/degree of access to intellectual property associated with a tool, nor does it consider restrictions related to patent claims. An MDDT submitter may include and protect proprietary methods as long as access to the tool is not restricted to certain private entities.”

FDA will begin accepting nominations to the pilot program on Sept. 14.

FDA Launches Pilot Program To Qualify Medical Device Development Tools

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