This medical device 510(k) training will explain the basics of 510(k) submissions and discuss tips, strategies and tools to develop and execute an approval strategy ensuring the fastest possible path to market.
All functional groups who have product development and approval responsibility or need to understand the basics of product approvals should attend.
Why Should You Attend:
This webinar will provide the tools and understanding you will need for a successful 510(k) submission. It will cover how to develop a submission strategy, and how to complete the component parts of a 510(k) submission. It will address the different types of 510(k) submissions, and when to utilize each type of submission. We will discuss the principle of substantial equivalence, how to identify a suitable predicate device, and how to effectively demonstrate equivalence. A critical part of the submission process is responding to FDA questions; this webinar will provide you with proven responses to speed your path to market. Attending this session will help you avoid the most common pitfalls in 510(k) submissions and avoid costly delays in your product approvals.All functional groups who have product development and approval responsibility or need to understand the basics of product approvals should attend.
Areas Covered in the Seminar:
- Overview of the Medical Device Approval Regulations
- Types of 510(k) pathways
- How to identify a predicate device
- Defining the Indented Use
- Making the case for substantial equivalence
- Device Labeling and Instructions for Use
- When to submit a 510(k) for device changes
- How to address requests for additional information
- How to avoid a not-substantially equivalent (NSE) determination
- How to obtain the broadest approval possible
Who Will Benefit:
- Regulatory Affairs
- Quality Assurance
- Compliance
- Research and development
- Quality Engineering
- Risk Managers
- Executive Management
- Controllers
- Risk Management
- Supply Chain Managers
Course Provider
Chris Cook,
