A draft guidance issued Nov. 13 by FDA seeks to speed up the approval pathway for medical devices by introducing a voluntary process to get development tools validated so that any company that wishes can use them.

The draft defines a medical device development tool (MDDT), as a scientifically validated method that aids in device development and regulatory evaluation. Such tools can include a clinical outcome assessment relying on subjective measures, such as patient-reported or clinician-reported rating scales; a test used to objectively detect or measure a biomarker; or a non-clinical assessment method or model, such as an in vitro, animal or computational model.

The tools are intended to help CDRH eliminate redundant reviews of a test. Once a tool has been qualified by FDA for a specific context, it can be used by any medical device developer within that context, the agency says. While companies would never be required to use a qualified MDDT, device reviewers will always accept the tools for the qualified context without needing to reconfirm its suitability.

The intent of the voluntary qualification program, FDA says, is to “(1) enable faster, more efficient development of important life-saving and health promoting medical devices, (2) promote the development of tools to facilitate more timely device evaluation, (3) provide a mechanism to better leverage advances in regulatory science, (4) and more quickly and more clearly communicate to stakeholders important advances in regulatory science that may be leveraged to speed device development and regulatory evaluation.”

Medical Device Development Tools Guidance Goals

Enable faster, more efficient development of important life-saving and health promoting medical devices.
Promote the development of tools to facilitate more timely device evaluation.
Provide a mechanism to better leverage advances in regulatory science.
More quickly and more clearly communicate to stakeholders important advances in regulatory science that may be leveraged to speed device development and regulatory evaluation.

Source: “Medical Device Development Tools” draft guidance, Nov. 13, 2013.

FDA hopes the program will facilitate collaboration between companies and other organizations to work together to develop MDDTs, increasing the efficiency of tool development.

The agency says the guidance has been in development since early this year. Its focus dovetails closely with the Medical Device Innovation Consortium, which was formed in December 2012 as a public-private partnership between the device industry, academics and regulatory agencies, including FDA. (See Also see "Medical Device Innovation Consortium Launches, Aims To Start Projects In 2013" - Medtech Insight, 10 December, 2012..)

MDIC was created around that idea of collaboration among companies and others to establish more useful regulatory science tools. To start, the consortium has started a pilot using computer modeling and simulation to ensure faster development and approval of medical devices. (See Also see "Medical Device Innovation Consortium Advances Regulatory Science Projects" - Medtech Insight, 7 October, 2013.).

While MDIC was not involved in the guidance development, MDIC CEO William Murray said, “The specific Medical Device Development Tools draft guidance is aligned with the mission of the MDIC as we seek to leverage advances in regulatory science to expedite the development assessment and review of safe and innovative medical devices for the benefit of patients.”

He added, “As a voluntary process, the MDDT provide a means for the work product of pre-competitive collaboration to be recognized in the review process. There are several activities within MDIC’s modeling and simulation project in which we will seek to use the MDDT process to qualify a tool used in non-clinical assessment.”

FDA says it may eventually initiate a pilot program for MDDT qualification submissions, which they say would inform the effort to finalize this guidance.

The guidance also provides step-by-step guidance on the process for MDDT qualification, including an optional pre-qualification stage and a qualification determination stage. The considerations for qualification include description of the MDDT, its context of use, strength of evidence, and assessment of advantages and disadvantages.

The guidance’s appendix has a sample outline of a MDDT qualification submission.

Comments on the draft guidance are due Feb. 12.

FDA Expects Guidance On Validating Device Development Tools To Speed Approvals

More from Regulation

More from Policy & Regulation