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 1. Eventura World
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 3. The FDA's Qualification of Medical Device Development Tools (MDDT) Program


THE FDA'S QUALIFICATION OF MEDICAL DEVICE DEVELOPMENT TOOLS (MDDT) PROGRAM

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🎤  John E. Lincoln        |  📅  September 9, 2024   |  🕒  11 AM Eastern Time
US 

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WHY YOU SHOULD ATTEND:   

This webinar describes the US FDA's Medical Device Development Tools Program. It
is intended to facilitate device development, timely evaluation of medical
devices, and promote innovation by providing a more efficient and predictable
means for collecting the necessary information to support regulatory submissions
and associated decision-making. 

In July 2023, the US FDA published its final guidance on the MDDT Program. It
describes a voluntary program for the qualification of medical device
development tools (MDDTs) for use in the evaluation of devices regulated by
CDRH.  Specifically, this guidance describes the framework for voluntary
proposal and qualification of an MDDT, including definitions of applicable
terms, criteria for evaluating an MDDT for a specific context of use,
considerations for qualification, and the contents of a qualification package.
CDRH believes that MDDTs will facilitate the development and timely evaluation
of medical devices by providing a more efficient and predictable means for
collecting information to support regulatory submissions and associated
decision-making.













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Description:

An 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 to support
regulatory decision-making. The use of a qualified MDDT by a medical device
manufacturer is voluntary.  Qualification is based upon FDA review of a
developer's submitted MDDT Qualification Package. In general, MDDTs can be
categorized into three types: Non-clinical Assessment Models (NAMs), Biomarker
Tests (BTs), and Clinical Outcome Assessments (COAs). 

 1. A Non-clinical Assessment Model (NAM) is a non-clinical test model or method
    that measures or predicts parameters of interest in regard to device safety,
    effectiveness, or device performance. Qualified NAMs may be used to evaluate
    a new material property, modifications to an existing design, or a device
    feature historically evaluated through other bench, animal, or human
    testing.
 2. A Biomarker Test (BT) is a test or instrument used to detect or measure a
    biomarker. Reliable biomarkers can help reduce uncertainty during device
    development and evaluation by providing predictions about device
    performance.
 3. A Clinical Outcome Assessment (COA) describes or reflects how a person
    feels, functions, or survives and can be reported by a health care provider,
    a patient, a non-clinical observer (such as a parent), or through
    performance of an activity or task.




Areas Covered in the Session :  

 * The US FDA's MDDT Final Rule
 * The 3 types of MDDT's
 * The MDDT Qualification Package
 * The FDA's MDDT Review Process
 * Public Availability of an Approved MDDT 
 * Goal:  Reduction of use of clinicals, other bench, animal or human testing
 * Basic Requirements / FDA Expectations for Tool Usage

 Who Should Attend:

 * Senior management in Devices, Combination Products
 * Quality Assurance Departments
 * Regulatory Affairs Departments
 * Research and Development Departments
 * Manufacturing Departments
 * Engineering Departments
 * Operations Departments
 * Production Departments
 * Medical Device product development teams
 * Consultants



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FDA Medical Device MDDT


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