Food and Drug Administration (FDA) 510(k) clearance is a requirement to market medical device products in the United States. Consequently, medical device companies must determine the best regulatory path to bring their products to market, as well as what is needed to complete the 510(k) process, and when a 510(k) must be submitted.
This course provides participants with an overview of the FDA regulatory approval process, with a focus on avoiding regulatory issues and unnecessary expenses. Participants will also learn how to submit a successful Premarket Notification 510(k) Submission for a device or a device change as quickly and efficiently as possible and ensure a 510(k) submission can be quickly reviewed and cleared by the FDA in order to stay ahead of the competition.
Who Should Attend
This course is designed for individuals involved with medical device development, as well as those who would like to learn about the FDA regulatory approval process for medical devices.
Upon completion of this course, participants will have a solid understanding of the FDA regulatory approval process for medical devices, including the Premarket Notification 510(k) Submission Process, as well as Labeling, Marketing, and Post-market Responsibilities.
- Overview FDA regulatory classifications and requirements
- Primary routes to market: Premarket Approvals (PMAs), 510(k) and exemptions
- Elements of 510(k) and definitions
- 513(g) requests for designation
- Selecting a predicate: Substantial Equivalence and Scientific Validity
- General 510(k) principles on what to expect
- 510(k) structure: traditional, abbreviated, and special
- Modifications to devices and resubmission
- The FDA Review Process
The Premarket Notification 510(k) Submission Process
- The Regulatory Landscape: PMA vs. 510(k)
- The Process: What is expected and when a 510(k) is needed
- Modifications – Understand when a device needs a new 510(k) submission
- Labeling, Marketing, and Post-market Responsibilities
Combination lecture and classroom exercises
Available at QSG’s training facilities and on-site at your organization
Course instructor: Lori Kahler – Consultant, Quality/Regulatory Systems