Speaker: Dr Rima Padovani

Training Objectives

This training consists of 1 module of 4 hours. The objective of this module is to provide an overview of possible pathways for regulatory approval in the US of In Vitro Diagnostic (IVD) medical devices and to provide an overview of the US market access and differences with the European market. The training is aimed at management and regulatory employees of IVD manufacturers who seek to place their product on the US market.

Training Content

This training outlines the regulatory framework of US Medical Device Regulations (based on the Parts of Title 21 of the Code of Federal Regulations (CFR) and relevant guidance documents) applicable to IVDs.

By attending this training, you will receive in-depth knowledge on the following topics:

  • Regulatory pathways applicable to IVDs in the US, including their classification, and related submission type (Premarket Notification (510(k), De Novo, Premarket Approval (PMA), Humanitarian Device Exemption (HDE)). 
  • Other regulatory pathways relevant to products developed by IVD manufacturers, such as Research Use Only (RUO) and Laboratory Developed Test (LDT).
  • Requirements for performance studies, including analytical performance and clinical performance, discussing key performance parameters (e.g. accuracy, analytical sensitivity and specificity, stability, clinical sensitivity and specificity, positive and negative predictive values, etc.) and related testing methodologies (e.g. use of CLSI standards and, when available, of Special Controls).
  • Regulatory framework of clinical performance studies on IVDs: Investigational Use Only (IUO) vs Investigational Device Exemptions (IDE).
  • Clinical performance studies and specimen sourcing, including the use of prospectively collected specimens, leftover specimens or archived/biobank samples.
  • When relevant, international regulatory guidance documents (such as those published by IMDRF, and WHO) are also integrated in the training.
  • Overview of the differences between the European and US market access

Training Format

  • Presentations with interactive discussions
  • Group and individual exercises
  • End of training assessment


This training is an introductory course; hence no prerequisite is set on regulatory knowledge. A good understanding of IVDs in terms of product development is recommended.


EUR 415 incl. course material and certificate


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