FDA launches pilot program for qualification of medical device development tools

Medical device evaluation can only be as effective as the tools used to conduct the evaluation. The FDA has begun seeking applications for the Medical Device Development Tools (MDDT) Pilot Program to validate and review such tools in preparation for a final guidance on the topic.

The FDA defines a medical device development tool as "a scientifically validated tool--a clinical outcome assessment, a test used to detect or measure a biomarker or nonclinical assessment method or model--that aids device development and regulatory evaluation," according to the November 2013 draft guidance entitled "Medical Device Development Tools."

Clinical outcome assessments fall into three categories: subjective, patient- or clinician-reported clinical outcome assessments like the NIH Stroke Score; objective biomarker tests including medical imaging tests and assays for measuring the level of a hormone; and nonclinical assessment models including computer models and in vitro models. The up to 15 tools selected for participation in the pilot program will have a chance to receive FDA "qualification."

"The decision to qualify an MDDT means that after reviewing relevant available scientific evidence, CDRH [the FDA's device arm] intends to consider the MDDT a valid tool within the defined context of use and to rely on assessments using the MDDT for regulatory purposes," the draft guidance states. FDA will publish qualified tools' context of use, summary of evidence and the justification for the decision.

The pilot program's website says the agency "will keep proprietary information confidential, and places no requirements on licensing, pricing, or intellectual property." However, the qualified tool must be publicly accessible and cannot be restricted to single manufacturers or other single private entities.

The FDA says the pilot program will facilitate the more timely development of reliable medical device development tools for use by manufacturers and the agency itself. Nominations can be sent to [email protected] There is no submission fee. Detailed information about the pilot program, as well as the nomination process and submission content, can be found in the Federal Register.

Nominations will accepted until the publication of the final guidance.

- here's the pilot program website
- read more details in the Federal Register
- see the draft guidance on device development tools (PDF)