Course Description

Regulatory Framework for In-Vitro Medical Devices in the US

Course Description:

This course offers a clear and comprehensive view of the regulatory framework surrounding in vitro diagnostic (IVD) medical devices in the US.
Despite their technical recognition as a sub-class of medical devices, IVDs face different FDA expectations for pre- and post-market commercialization. This course provides detailed insight into this process, including applicable definitions, classification schemes, market trajectory, pre-market submissions, Clinical Laboratory Improvement Amendments (CLIA) categorization, quality system requirements, and post-market requirements for IVDs, as well as an introduction to the new sub-class of IVDs: companion diagnostics.

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Learning Objectives:

Upon successfully completing this course, students will be able to:

  • Gain a comprehensive overview of IVDs with a focus on the FDA’s specific regulatory requirements, including drafts on companion diagnostics
  • Grasp the essential regulatory requirements applicable to IVD regulations, which includes:
    • Product classification
    • IVD development and pre-market submissions
    • Quality Management Systems (21 CFR 820)
    • Post-market requirements
    • Proposed and current interactions with the FDA

Who Should Enroll:

Regulatory affairs associates, regulatory affairs managers, quality assurance associates, quality assurance managers, quality assurance engineers, manufacturing engineers, supply managers, purchasing managers, design engineers, validation engineers, notified body auditors, regulators, electrical safety engineers, internal auditors, lead auditors, pre-clinical study managers, clinical affairs directors, clinical project managers, export managers, and R&D engineers are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

Those who enroll should have knowledge of the Investigational Device Exemption (IDE) process. Additionally, the WMDO course “Overview of US FDA” is recommended but not required.

Subject Matter Expert:
Sabah Malek

60 min

Release date:

Related resources:

Case studies:

Basic Account: € 177.00
Premium Account: € 133.00

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