This presentation will review methods for finding predicates, using guidance documents and interacting with the agency. Participants will learn about the different types of 510(k) submissions and the benefits and drawback of using the 3rd party.
Targeted to the small company with limited RA/QA resources, or to the new RA/QA professional, this webinar will introduce the basic concepts and best practices of the 510(k) submission process. We will also discuss other communication tools such as the request for information (513g) and preIDE meeting.
Targeted to the small company with limited RA/QA resources, or to the new RA/QA professional, this webinar will introduce the basic concepts and best practices of the 510(k) submission process. We will also discuss other communication tools such as the request for information (513g) and preIDE meeting.
Areas Covered in the Seminar:
- Best Practices in 510(k) Submissions
- Strategies for finding predicate devices.
- The three types of 510(k) submission and when they’re used.
- The benefits and drawbacks of using the 3rd party review process.
- Agency communication tools.
- What do I do if clinical data are reqiured for my 510(k)
Who Will Benefit:
- Regulatory Affairs
- Quality Assurance/Control
- Engineering
- Research & Development
- Quality Systems Management
- Documentation Management
- VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs
Course Provider
William G Mclain,
