Course Description:
This interactive one and a half day seminar will cover the basics and advanced knowledge of the 510(k) program. It will provide insights on what FDA looks for in 510(k) submissions and common mistakes companies make in drafting 510(k)s. The course will include observations and commentary on CDRH's new proposals for the 510(k) program such as:
Draft Guidance for Industry and Food and Drug Administration Staff.
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].
The general/specific intended use guidance document and the FDA's approach to interpreting it using real examples.
This seminar will also address the positives and negatives of pre-IDE meetings and how to approach them. Finally, it will address how to appeal adverse 510(k) decisions, whether it is an NSE decision or an Additional Information letter.
This interactive one and a half day seminar will cover the basics and advanced knowledge of the 510(k) program. It will provide insights on what FDA looks for in 510(k) submissions and common mistakes companies make in drafting 510(k)s. The course will include observations and commentary on CDRH's new proposals for the 510(k) program such as:
Draft Guidance for Industry and Food and Drug Administration Staff.
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].
The general/specific intended use guidance document and the FDA's approach to interpreting it using real examples.
This seminar will also address the positives and negatives of pre-IDE meetings and how to approach them. Finally, it will address how to appeal adverse 510(k) decisions, whether it is an NSE decision or an Additional Information letter.
