Medical Device Development Tools Final Guidance Document

On August 10, 2017, FDA-CDRH published the final guidance document Qualification of Medical Device Development Tools.

A Medical Device Development Tool, MDDT, is a method, material, or measurement used to assess the effectiveness, safety, or performance of a medical device. An MDDT is scientifically validated and can be qualified for use in device evaluation and to support regulatory decision-making such as clinical outcome assessments, assessments of biomarkers, and nonclinical assessment methods or models.

MDDT Qualification is a conclusion, based on FDA review, that within the stated context of use, the MDDT can be relied upon to have a specific interpretation and application in medical product development and regulatory review.

An MDDT that is qualified for a specific context of use may be used by any device sponsor for that use context.

The guidance document describes three types of MDDTs, distinguished primarily by how the tool measures relevant parameters: Clinical Outcome Assessments (COAs), Biomarker Tests (BTs), and Nonclinical Assessment Models (NAMs).

A Clinical Outcome Assessment (COA) can be made through report by a clinician, a patient, a non-clinician observer or through a performance-based assessment.

There are four common types of COAs: patient-reported outcome (PRO) measures, clinician reported outcome (ClinRO) measures, observer-reported outcome (ObsRO) measures, and performance outcome (PerfO) measures.

A Biomarker Test (BT) is a test or instrument used to detect or measure a biomarker.

A Non-clinical Assessment Model (NAM) is a non-clinical test model or method that measures or predicts device function or in vivo device performance.