This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures.
This Medical device training will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company’s regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate.
This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance.
- When to submit a 510(k) for a new or modified product.
- Types of 510(k) submissions and when to use each.
- What is the submission process.
- What is contained in a 510(k) submission package.
- How to know whether clinical data is required.
- How is the submission package assembled.
- User fees and 510(k) submissions.
- How to interact with the FDA and the reviewer.
- What to do if you make a change to your device.
- Research & Development Departments
- Engineering Departments
- Quality Assurance Departments
- Regulatory Affairs Departments
- New Product Development
- Marketing Departments
- Mid-level and Senior Management
- Project Leaders
- Professionals involved with premarket notification to the FDA