Training Features

Successful US FDA Submission: Practice for medical devices and IVDs

Join our virtual training on 19 and 20 August 2026 to learn how to prepare strong FDA submissions that support a smooth review and help bring your medical device or IVD to the US market with confidence.
Format

Virtual Training

Level

Basic

Date

19 and 20 August 2026

Time

14:00 - 18:00 CET

Duration

2 x 4 hours

Trainer

Tim Joiner

Certificate

Certificate included

Price

€ 1195 or equivalent currency

FDA Submission Pathways, Preparing Successful Applications for the
U.S. Market

Bringing a medical device or in vitro diagnostic (IVD) to the U.S. market requires a thorough understanding of the FDA’s regulatory submission processes. A well-prepared submission is essential for gaining market approval efficiently and avoiding costly delays.

Led by Tim Joiner, this interactive training provides practical insights into the different FDA submission pathways, including 510(k), De Novo, and Premarket Approval (PMA) applications. Participants will learn best practices for preparing a strong submission, engaging with the FDA, and navigating common challenges to ensure a smooth regulatory review. The course also covers key components of successful submissions, common deficiencies, and strategies to streamline the approval process.
Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
Bringing a medical device or an IVD into the U S market requires a clear understanding of how the FDA reviews and evaluates submissions. A well structured application supports an efficient approval process and helps prevent delays that can affect market entry.

This virtual training introduces the main FDA submission routes, including 510 k, De Novo and PMA applications. Participants learn how to prepare complete and well organized submissions, how to work with the FDA during review, and how to avoid common issues that slow down approval. The session also highlights key elements of successful applications and practical strategies that support a smooth and predictable submission process.
Key Learning Objectives
  • Understand the different FDA submission pathways and when to use them
  • Learn how to prepare a high-quality 510(k), De Novo, or PMA submission
  • Gain insights into IVD-specific regulatory requirements for FDA submissions
  • Understand the benefits of FDA Pre-Submission meetings and how to prepare for them
  • Learn best practices for structuring technical documentation and supporting data
  • Identify common mistakes that lead to submission delays and how to avoid them
  • Gain practical strategies for interacting with FDA reviewers and responding to deficiencies
  • Understand the post-market obligations following FDA approval.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in two sessions, lasting 4 hours each, providing a focused and efficient learning experience. The sessions will take place on 19 and 20 August 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held on 25 and 26 February, 19 and 20 May, and 16 and 17 December 2026. More information can be found on the registration pages.
Who Should Attend?
  • Regulatory Affairs professionals responsible for FDA submissions
  • Medical device and IVD manufacturers planning U.S. market entry
  • Quality Assurance professionals preparing compliance documentation
  • Clinical and R&D teams generating data for FDA submissions
  • Professionals handling FDA Pre-Submission meetings and regulatory strategy
  • Post-market surveillance teams ensuring compliance after approval
  • Internal auditors assessing FDA submission readiness within their organization
  • Senior management overseeing FDA submission processes and approvals.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Overview of FDA Submission Pathways – Covers 510(k), De Novo, PMA, and IDE pathways, when to use each, key regulatory considerations, and the role of Breakthrough Device and Safer Technologies (STeP) programs.
  • Preparing a Strong 510(k) Submission – Guidance on determining substantial equivalence, selecting predicate devices, application content and format, and avoiding common rejection reasons.
  • De Novo Classification and PMA Process – When to pursue De Novo for novel devices, PMA requirements for high-risk devices, and FDA review timelines and expectations.
  • IVD-Specific Submission Requirements – Special considerations for in vitro diagnostics, analytical and clinical validation, and requirements for Laboratory Developed Tests (LDTs) and companion diagnostics.
  • Key Elements of a Successful FDA Submission – Technical documentation, test data, labeling and Instructions for Use (IFU), and cybersecurity/software validation for digital health products. 
  • Pre-Submission Meetings with the FDA – Benefits of early engagement, requesting and conducting Pre-Submission (Q-Sub) meetings, and best practices for obtaining actionable FDA feedback.
  • Common Submission Pitfalls and How to Avoid Them – Avoiding incomplete or inconsistent documentation, addressing FDA-identified deficiencies, and responding effectively to Additional Information (AI) requests.
  • FDA Review Process and Post-Submission Actions – Understanding FDA decision-making and timelines, handling reviewer questions, and next steps including post-market compliance.

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

Tim Joiner

Tim Joiner is a Senior Consultant with more than two decades of experience leading quality and regulatory strategies across the medical device and pharmaceutical sectors, specializing in quality management systems, global regulatory compliance, audit readiness, design control, and risk management.