The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications

Each 510(k) submission poses a new set of challenges and new variations, depending on the type of device, the risk level, and its history. Therefore, it is essential to have a strong understanding of the most up-to-date 510(k) submission requirements and how they relate to your device for the most efficient submission process. This course will elaborate device classification, overview the 510(k) program, and discuss FDA submissions.

Why Should You Attend:

The process of compiling and submitting a 510(k) for medical device companies, especially small companies, can be ambiguous. It requires considerable investment of time and resources. Toiling through this process can be overwhelming and also a constant struggle with bureaucratic hurdles. Understanding how this process works and the reasoning behind the FDA’s decision making process can not only save time and money, but also position the company in market advantage.

This webinar will give you a better understanding of FDA’s current position regarding the 510(k) process and provide you with the resources necessary to develop a better regulatory strategy. It will detail the process of demonstration of substantial equivalence, the 510(k) process, and also highlight best practices for premarket notification 510(k) submissions.

Areas Covered in the Webinar:

• Device classification as it relates to 510(k)s
• Device classification
• Overview of 510(k) program
• Content of a 510(k)
• 510(k) submission process
• 510(k) decisions

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Regulatory Affairs
• Quality Assurance
• Compliance
• Research and Development
• Quality Engineering
• Risk Managers
• Executive Management
• Risk Management