Registration of Medical Devices in the USA – Part 2 - FDA 510(k) (Advanced Course)

This course is intended for:

• Regulatory Affairs Professionals
• Medical Device Regulatory Managers
• Quality Assurance Professionals
• Quality Management System Personnel
• Product Development Engineers
• R&D Specialists
• Regulatory Consultants
• Compliance Managers
• Medical Device Manufacturers and Exporters
• Professionals responsible for FDA market access activities

Module 1: Market Access Through the FDA 510(k) Process

• FDA 510(k) regulatory framework
• Predicate device selection
• Substantial equivalence principles
• FDA clearance process
• Quality system considerations

Module 2: Preparing a 510(k) Submission

• Submission content requirements
• Device description requirements
• Intended use and indications for use
• Performance testing expectations
• Clinical evidence considerations
• FDA guidance documents and consensus standards

Module 3: FDA eSTAR Submission Process

• Structure and functionality of eSTAR
• Submission preparation
• eSTAR validation and verification
• Common submission deficiencies
• Practical eSTAR workshop

Module 4: Traditional and Abbreviated 510(k)

• Traditional 510(k) pathway
• Abbreviated 510(k) pathway
• Summary reports
• Special controls
• Consensus standards
• Declaration of conformity

Module 5: De Novo Classification Process

• Eligibility criteria
• FDA classification principles
• Direct De Novo pathway
• Risk-benefit evaluations
• Special controls
• Submission requirements
• FDA review timelines

Module 6: Special 510(k) and Design Modifications

• FDA change management requirements
• Device modifications requiring new submissions
• Software change evaluations
• Special 510(k) eligibility
• Design control considerations
• Verification and validation expectations

Module 7: Practical Workshops

• Predicate device identification
• Substantial equivalence exercises
• eSTAR completion activities
• Significant change assessment exercises
• Group discussions and case studies

The United States remains one of the world's largest and most important healthcare markets. For medical device manufacturers seeking successful market access, understanding the FDA's premarket submission requirements is critical. This advanced training course provides an in-depth examination of the FDA 510(k) process and the regulatory strategies used to obtain market clearance for medical devices.

Building on the knowledge gained in Part 1, participants will explore the complete lifecycle of a 510(k) submission. The course covers the selection of appropriate predicate devices, preparation of substantial equivalence arguments, regulatory expectations for device descriptions, indications for use, performance testing, and clinical evidence requirements. Participants will also learn how FDA-recognized consensus standards and guidance documents can support an effective submission strategy.

In addition to Traditional and Abbreviated 510(k) submissions, the course examines alternative regulatory pathways, including the De Novo classification process for novel devices that lack a suitable predicate. Participants will gain insight into FDA decision-making, risk-based classification principles, and the preparation of De Novo requests.

The training also addresses one of the most common regulatory challenges faced by manufacturers: determining when product modifications require a new 510(k). Attendees will review FDA guidance on design changes, software modifications, labeling updates, and significant changes that may impact safety or effectiveness. Special 510(k) submissions will also be covered, including eligibility criteria and documentation requirements.

A key feature of this course is its practical workshop component. Participants work through real-world exercises involving predicate identification, substantial equivalence evaluations, and preparation of submission information within the FDA's eSTAR platform, providing valuable hands-on experience that can be directly applied to future regulatory submissions.

Upon completion of this course, you will be able to:

• Understand FDA expectations for successful 510(k) submissions
• Select appropriate predicate devices and justify substantial equivalence
• Differentiate between Traditional, Abbreviated, and Special 510(k) pathways
• Understand when the De Novo pathway should be used
• Apply FDA-recognized consensus standards and guidance documents
• Determine when design or software modifications require a new 510(k)
• Prepare submission content using the FDA eSTAR platform
• Reduce regulatory risks associated with incomplete or inadequate submissions
• Improve regulatory planning and market access strategies for the U.S. market
• Gain practical experience through hands-on workshop exercises

This instructor-led training is delivered in a live virtual classroom environment.

Learning methods include:

• Expert-led presentations
• Practical regulatory examples
• Interactive discussions
• Case studies
• Group exercises
• FDA submission workshops
• eSTAR demonstration and hands-on activities
• Q&A sessions

Participants interact directly with the instructor and peers through webinar technology. Webcam and microphone participation is recommended to maximize engagement.

Participants will be evaluated through:

• Interactive participation during instructor-led discussions
• Group workshop exercises
• Practical FDA 510(k) case studies
• Completion of hands-on eSTAR activities
• Knowledge checks and instructor feedback throughout the course

Participants who attend at least 90% of the total training duration will receive a Certificate of Attendance from TÜV SÜD Academy upon successful participation in the training.

Participants will receive:

• Electronic training materials and presentation slides
• Workshop exercises and practical examples
• Regulatory references and guidance resources discussed during the course
• Supplemental FDA guidance references for further study

Participants are encouraged to have access to a laptop computer or mobile device during the training to fully participate in the eSTAR workshop exercises.

Participants should have:

• Basic knowledge of medical device regulations
• Familiarity with FDA medical device requirements
• Prior experience in Regulatory Affairs, Quality, Compliance, Product Development, or related fields

Required: Successful completion of:

Registration of Medical Devices in the USA - Part 1 (Basic Course)

or equivalent knowledge of FDA market access fundamentals.

Learning Path:

• This training course is part of a modular learning path. After successful participation in the advanced modules, you can acquire this recognized qualification:
  • Manager Regulatory Affairs International - TÜV
• The course deals with internationally valid standards and is also suitable for implementation abroad.

Do I need prior FDA regulatory knowledge to attend?

Yes. Participants should have a foundational understanding of FDA medical device regulations. Completion of Registration of Medical Devices in the USA - Part 1 (Basic Course) is strongly recommended.

What types of FDA submissions are covered?

The course covers Traditional 510(k), Abbreviated 510(k), Special 510(k), and the De Novo Classification Process.

Will I learn how to prepare a 510(k) submission?

Yes. Participants learn the structure, content, and regulatory expectations of a 510(k) submission, including predicate selection, substantial equivalence, testing requirements, and submission documentation.

Does the course include eSTAR training?

Yes. A dedicated workshop provides practical exposure to the FDA's eSTAR electronic submission platform and submission preparation process.

What is a predicate device and why is it important?

A predicate device is a legally marketed device used to establish substantial equivalence for a new device. Selecting an appropriate predicate is a critical element of a successful 510(k) submission.

Does the course explain when a new 510(k) is required for design changes?

Yes. The course reviews FDA guidance on product modifications, software changes, labeling updates, and other changes that may require submission of a new 510(k).

Will De Novo submissions be covered?

Yes. Participants will learn when the De Novo pathway is appropriate, how FDA evaluates De Novo requests, and the documentation typically required.

Are practical exercises included?

Yes. The course includes multiple workshop activities involving predicate selection, substantial equivalence analysis, eSTAR completion, and design change assessments.

Is this course suitable for software medical devices?

Yes. The course includes FDA guidance regarding software modifications and determination of when software changes may require a new 510(k) submission.

Will I receive a certificate?

Yes. Participants who attend the training will receive a TÜV SÜD Academy Certificate of Attendance.

Can the knowledge be applied immediately within my organization?

Absolutely. The course is designed around practical FDA requirements, current regulatory guidance, and real-world submission activities that participants can immediately apply to ongoing projects.

Does this course cover FDA inspections or Quality System Regulations?

The course discusses the relationship between FDA clearance activities and quality system requirements, including considerations related to design controls and post-clearance inspections, but its primary focus is the premarket submission process.

Train with Industry Experts

Learn from specialist instructors at TÜV SÜD Academy—recognized leaders with deep expertise in their fields. For over 35 years, our global network of 2,500+ trainers has delivered practical, real-world knowledge that you can apply immediately. Our courses are continuously updated to reflect the latest regulatory changes and industry best practices, ensuring you gain relevant, up-to-date skills with every session.