Advanced Module on Regulatory Pathways for Medical Devices in the U.S.
If you want to launch a medical device on the U.S. market, you need to understand the appropriate regulatory pathway with the FDA, because only by following the correct procedure will you obtain the necessary market authorization. This seminar provides a comprehensive overview of the various approval processes for medical devices in the U.S. and shows you how to identify the right path for your product.
You will learn about the structure and workflow of the 510(k) process, discover the different options available, and understand how to meet the formal requirements, including electronic submission via eSTAR. You will also gain insights into the review process, communication with the FDA, and how to handle follow-up inquiries.
In addition, the Q-Submission program, the De Novo Request, and alternative procedures such as PMA, HDE, and IDE will be presented. For cases where classification is unclear, you will learn when and how to submit a 513(g) Request for Classification.
- Content
- Overview: 510(k)
- Fundamentals, objectives, and regulatory significance of the 510(k) process
- Types of 510(k) procedures
- Traditional, Special, and Abbreviated 510(k) – Differences and use cases
- Formalities and eSTAR
- Electronic submission, formats, deadlines, and common pitfalls
- Review process
- Process, communication with the FDA, and evaluation criteria
- Responses to inquiries
- Strategies for successful interaction during the review process
- The Q-Submission Program
- Options for preliminary consultation with the FDA and practical tips for pre-submissions
- De Novo Request
- Requirements, process, and benefits for innovative products
- PMA / HDE / IDE
- Overview of alternative and highly regulated approval procedures
- When nothing else works: 513(g) – Request for Classification
- Procedure for unclear classification and use as a guide
- Your Benefits
- You will be familiar with the various FDA approval processes and will be able to choose the right path for your product.
- You will understand the requirements and procedures of the 510(k) process and know how to use eSTAR effectively.
- You will be able to confidently respond to FDA inquiries and actively participate in the review process.
- You will learn how to resolve uncertainties early on using the Q-Submission program and the 513(g) inquiry.
- You will receive practical guidance on planning and executing submissions.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Regulatory Affairs Managers
- Quality Management Representatives
- Medical device manufacturers and authorized representatives
- Staff in development, regulatory affairs, and project management
- Service providers and consultants specializing in regulatory strategy and FDA compliance
