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USFDA Guidance: Qualification of Medical Device Development Tools

Today (17 July 2023) the USFDA's Center for Devices and Radiological Health (CDRH) released final guidance on "Qualification of Medical Device Development Tools".

The purpose of this document is to provide guidance on a voluntary program for training medical device development tools (MDDTs) for use in evaluating devices regulated by the Center for Devices and Radiological Health (CDRH).

Medical Device Development Tool (MDDT) is a method, material, or measurement used to assess the safety, effectiveness, or performance of a medical device.

An MDDT is scientifically substantiated and can be qualified for use in device evaluation and to support regulatory decision-making within a specified context of use. Examples of MDDTs are non-clinical assessment models (NAMs), biomarker tests (BTs), and clinical outcome assessments (COAs).

It is the purpose of this guidance to make it clear to medical device manufacturers that certification can increase predictability and efficiency in regulatory decision-making by improving predictability in device evaluation. FDA accepts assessments from qualified MDDTs to demonstrate the safety, effectiveness, or performance of a medical device, without the need for reconfirmation of MDDT suitability and utility, as long as they are used within a qualified COU.

In specific, this guidance describes the framework for voluntary submission and qualification of MDDTs, including definitions of relevant terms, criteria for evaluating MDDTs for specific contexts, considerations for qualification, and qualification packages.

The voluntary qualification process consists of two phases, the Proposal Phase and Qualification Phase, which are described below.

  • Proposal Phase: In the proposal phase, CDRH will first review the MDDT Proposal Package in order to determine if a proposed MDDT is eligible for qualification under the MDDT program.

  • Qualification Phase: In the qualification phase, the tool is qualified based on the evidence provided for a specific COU.

To know more about CDRH Qualification Decision Framework etc. check out this LINK.


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