The FDA's Qualification of Medical Device Development Tools (MDDT) Program

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.

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.

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

Course Director: JOHN E. LINCOLN  

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.