Bringing a medical device to the U.S. market requires selecting the appropriate FDA regulatory pathway. Choosing incorrectly can result in delays, additional data requests, or the need to re-submit under a different pathway.

This webinar provides a structured overview of the FDA’s primary device submission routes, including:

• 510(k) Premarket Notification
• Premarket Approval (PMA)
• Investigational Device Exemption (IDE)
• De Novo Classification
• Device exemptions and classification considerations

Attendees will gain clarity on how devices are categorized, what documentation is generally required, and how submission pathways differ in review expectations and regulatory standards.

The session is designed to support professionals who are involved in planning, preparing, reviewing, or overseeing medical device submissions.

After this webinar attendees will be able to answer—

• What are the primary FDA regulatory pathways for medical devices?
• When is a 510(k) submission required?
• What distinguishes a PMA from a 510(k)?
• When may a device qualify for exemption?
• How does the De Novo pathway apply to novel devices?
• What factors influence proper device classification?
• What are the general submission expectations for each pathway?

This webinar benefits the following agencies:

• Medical device manufacturers
• Regulatory consulting firms
• Clinical research organizations
• Quality and compliance departments
• Product development teams

Who should attend?

• Regulatory Affairs professionals
• Quality Assurance and Compliance managers
• Clinical and R&D teams
• Product development professionals
• Executive leadership overseeing regulatory strategy
• Anyone involved in preparing or supporting FDA device submissions