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Draft Guidance for Industry and Food and Drug Administration Staff.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.Learning Objectives:
The FDA’s new narrow view of “general versus specific intended use,” under which the FDA now considers almost every new indication for a 510(k) device to be a new intended use such that the agency can then conclude the applicant has no legally marketed predicate device to which it can claim Substantial Equivalence and must file an onerous PMA for;
Permission structure for FDA review staff to inappropriately consider clinical utility/benefit and, in the case of in vitro diagnostics, clinical truth and operational truth, as part of the Substantial Equivalence criteria, which is inconsistent with the statute and the ReGen opinion;
Allowing FDA review staff to inappropriately consider statutes and regulatory matters extraneous to the Substantial Equivalance decision (e.g., cGMP/Quality Systems, MDR, FD&C Act advertising and promotion, and OSHA regulations or CDC guidance);
Inappropriately applying risk mitigation and “assurance case” principles to the criteria for 510(k) clearance;
More restrictively interpreting when a device has a new technological characteristic and when those technological characteristics raise new questions of safety and effectiveness.
Responding to AI letters and appealing NSE decisions.